Digestive Endoscopy 2015; 27: 381–387
doi: 10.1111/den.12387
Original Article
Comparison between double-guidewire technique and transpancreatic sphincterotomy technique for difficult biliary cannulation Long Huang, Qing-sheng Yu, Qi Zhang, Ju-da Liu and Zhen Wang Department of No. 1 Surgery, The First Hospital Affiliated to Anhui Chinese Medical University, Hefei, China Background and Aim: The aim of the present study was to compare the effectiveness and complications of the doubleguidewire technique (DWT) with the transpancreatic sphincterotomy (TPS) technique. Methods: From January 2013 to December 2014, 366 consecutive endoscopic retrograde cholangiopancreatography (ERCP) procedures were carried out. Of 366 procedures, 354 procedures were carried out in patients with native major papilla biliary cannulation. A total of 279 consecutive therapeutic ERCP were included in the study and data of included patients were collected retrospectively. One hundred and thirty-seven procedures (49.1%) were done with DWT and 142 procedures (50.9%) were done with TPS for patients with difficult cannulation. The results and complications of ERCP were compared. Results: Success rate of first-attempt cannulation was 62.0% in the DWT group and 81.0% in the TPS group (P = 0.00). Final rate of
INTRODUCTION
S
ELECTIVE CANNULATION OF the biliary duct is the most important step for successful treatment of biliary tract diseases during endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, despite various accessory devices, the standard biliary cannulation technique has been reported to fail in approximately 5–20% cases.1 As the technique developed, several supplementary techniques have been recommended to facilitate access to the common bile duct (CBD) in cases of standard biliary cannulation failure. These are known to significantly increase not only the success rate of selective biliary cannulation but also the complication rate.2
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Corresponding: Long Huang, Department of No. 1 Surgery, The First Hospital Affiliated to Anhui Chinese Medical University, no. 117 Meishan Road, Hefei 230031, Anhui Province, China. Email: [email protected] Received 12 June 2014; accepted 22 September 2014.
successful cannulation of the two biliary cannulation techniques was 86.9% and 90.8%, respectively (P = 0.09). Cannulation time in the DWT group was 7.8 ± 1.7 min compared with 3.7 ± 2.3 min in the TPS group (P = 0.00). Overall incidence of post-ERCP pancreatitis (PEP), hemorrhage, perforation and cholangitis was 1.8%, 1.1%, 0.4% and 1.1%, respectively. Adverse event rate was 2.19% in the DWT group and 7.04% in the TPS group (P = 0.04).
Conclusions: DWT and TPS procedures were safe and effective. Overall cannulation rate was similar between the groups. Although DWT had a longer cannulation time, it could be considered the preferred technique in patients with failed standard cannulation for lower adverse event rate. Keywords: biliary cannulation, complication, double-guidewire technique, endoscopic retrograde cholangiopancreatography (ERCP), precut technique
Commonly, a precutting technique is used to allow biliary access when the standard cannulation technique failed. There are three types of precutting technique: needle-knife papillotomy, suprapapillary fistulotomy and transpancreatic sphincterotomy (TPS). In terms of effectiveness and efficiency of the precutting technique, TPS, which need not avoid pancreatic duct cannulation unintentionally, is an effective method especially for difficult biliary cannulation.3 Furthermore, more advanced techniques have also been developed to aid biliary access if it is unsuccessful with standard devices.4 For surgically altered gastrointestinal anatomy, some special skills should be considered.5,6 Enterography route, which crosses the greater curvature of the stomach and the ‘lower entrance’ at the site of the gastrojejunal anastomosis, along the efferent loop, and goes through the ‘middle entrance’ at the site of the Braun anastomosis to reach Vater’s papilla, is optimal for patients with Billroth II gastroenterostomy and Braun anastomosis.7,8 For patients with cholecystolithiasis and choledocholithiasis, the rendezvous technique is appropriate, accompanied by laparoscopic cholecystectomy.9 Rendezvous technique can
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reduce pancreatic enzyme leakage compared with conventional ERCP cannulation technique.10 In 2003, the early double-guidewire technique (DWT) was reported in the adult literature for cases associated with low complication and high success rates.11 In terms of DWT procedure, this technique is a useful aid for the endoscopist attempting to selectively cannulate the CBD in difficult cases. Further study will be needed to establish the safety of advanced techniques in the pediatric population.12 However, there is no consensus on the type of advanced techniques to achieve safe and successful CBD cannulation. This may be because of multiple confused attempts to achieve CBD cannulation causing excess edema and papillary trauma. What is the best treatment strategy if the pancreatic duct is repeatedly unintentionally cannulated with the guidewire and biliary cannulation is not achieved? The DWT and TPS procedures are all suitable for this situation. So far, data on advanced techniques are still limited. The aim of this retrospective study was to compare the results and complications of DWT with TPS for difficult biliary cannulation in a study with a large number of subjects.
METHODS Patients and techniques
A
T ANHUI CHINESE Medical Research Institute of Surgery, 366 consecutive endoscopic retrograde cholangiopancreatography (ERCP) procedures were carried out (Fig. 1). Of 366 procedures, 354 procedures were done in patients with native major papilla biliary cannulation. A total of 279 consecutive therapeutic ERCP procedures using the DWT or TPS technique by one experienced endoscopist from January 2012 to December 2013 were carried out. The most suitable cannulation technique for included patients was selected by the endoscopist according to the major papilla. Patients were excluded if they had any other cannulation techniques, such as needle knife sphincterotomy, except DWT and TPS techniques. Eighty-seven ERCP procedures with successful standard biliary cannulation or diagnostic ERCP procedures were excluded. All clinical data were collected in the study. Before ERCP, all patients or their relatives provided informed consent and the investigation was carried out in accordance with the principles of the Helsinki Declaration of 1975, as revised in 2013. The Institutional Review Board of the Anhui Provincial Traditional Chinese Hospital approved the study protocol. All included patients were classified into two groups: double-guidewire technique group (DWT) and transpancreatic sphincterotomy group (TPS) according to the method
Digestive Endoscopy 2015; 27: 381–387
ERCP procedures (n = 366) Native major papilla biliary cannulation (n = 354)
Patients received endoscopic sphincterotomy before admission (n = 12)
Native major papilla using DWT or TPS (n = 270)
Patients with previous endoscopic sphincterotomy using DWT or TPS (n = 9)
ERCP using DWT or TPS technique (n = 279)
DWT Received (n = 137)
TPS Received (n = 142)
Total success cannulation (n = 119) Complication (n = 3)
Total success cannulation (n = 129) Complication (n = 10)
Figure 1 Flow diagram of endoscopic retrograde cholangiopancreatography (ERCP) procedures. DWT, double-guidewire technique; TPS, transpancreatic sphincterotomy.
of biliary cannulation. All ERCP procedures were done using an Olympus video duodenoscope (JF-260V; Olympus Corporation, Tokyo, Japan). All cases were started with a standard ERCP catheter (double lumen sphincterotome, Ultratome XL; Boston Scientific, Natick, MA, USA) preloaded with contrast. A guidewire (0.035-inch Jagwire; Boston Scientific, Miami, FL, USA) was used to aid biliary cannulation (initial standard cannulation). However, if biliary cannulation failed after 10 min and the pancreatic duct was repeatedly unintentionally cannulated with the guidewire, supplementary cannulation techniques (including DWT and TPS) were used. The TPS procedure was applied with the Endocut mode in the ERBE system (120 W cut; 15 W coagulation; ERBE USA, Atlanta, GA, USA), which automatically adjusts the amount of cutting and coagulating current, depending on the tissue resistance. Also, the ERBE settings were used for all sphincterotomies. Sedation for the procedures consisted of a combination of meperidine and diazepam with raceanisodamine as needed for duodenal relaxation. Treatment for patients with biliary obstruction, such as common bile duct cancer, pancreatic cancer or biliary stricture, was placement of a stent with planned exchanges every 3–6 months. For the purpose of preventing post-ERCP pancreatitis (PEP), pancreatic stent was not placed conventionally unless the pancreatic duct was cannulated more than five times.
© 2014 The Authors Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society
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Double-guidewire technique 383
Surgery techniques
RESULTS
Double-guidewire technique was carried out with a guidewire inserted into the pancreatic duct. Then, with the former wire positioned in the pancreatic duct, the sphincterotome catheter was exchanged off the pancreatic duct guidewire and reintroduced down the endoscopic channel alongside it. The second wire was inserted at the ampullary orifice above the former pancreatic wire in the 11 o’clock direction. Finally, attempt at biliary cannulation was undertaken. TPS was conducted as follows. A guidewire was inserted deeply into the pancreatic duct; then a standard traction sphincterotome was wedged into the pancreatic orifice, and the sphincterotomy was carried out with a cutting wire along the biliary direction at 11 o’clock. The incision was made through the septum between the pancreatic and biliary duct with the aim of exposing the bile duct orifice. After transpancreatic sphincterotomy, attempt at biliary cannulation was undertaken.
B
Definition of outcomes Successful initial cannulation using standard cannulation technique was defined as free and deep placement of the sphincterotome into the CBD within 10 min. Standard cannulation was said to have failed when the bile duct was not cannulated after multiple attempts on the papilla. Changing to different cannulas and sphincterotomes could be used during the standard cannulation technique according to the endoscopist’s experience. All 279 patients included in this study had failed cannulation using the standard cannulation technique. The overall success rate was defined as eventual successful biliary cannulation. Cannulation time was measured from the time the cannulating device was inserted into the endoscopic channel to free and deep cannulation of the CBD. Definitions of complications after ERCP procedures were the same as those reported by Cotton et al.13 All included patients were contacted by telephone and specifically questioned regarding postoperative complications after ERCP procedures. All data of included patients were recorded in detail.
Data analysis Statistical analysis was done using Statistical Package for the Social Sciences (SPSS, Version 13.0, Chicago, IL, USA). Continuous variables were reported as means ± standard deviation (SD) or ranges. Comparison between groups was carried out using the t-test for measurement data and using χ2-test with or without Fisher’s exact test for categorical variables. Statistical significance was accepted at the 5% level by a two tailed test.
ETWEEN JANUARY 2012 and December 2013, a total of 366 ERCP procedures were carried out by one experienced endoscopist. Eighty-seven ERCP procedures with successful standard biliary cannulation or diagnostic ERCP procedures were excluded. Of the 87 procedures, 84 were native papillas, and three had previous endoscopic sphincterotomies or interventions. Of 279 ERCP procedures (135 male, 144 female; mean age 60.8 years) included in the study, 137 procedures were classified in the DWT group and 142 procedures were classified in the TPS group. Characteristics of the DWT and TPS groups are summarized in Table 1. A total of nine cases received endoscopic sphincterotomy before admission. There was no statistically significant difference between the two groups for any of these parameters. Factors affecting the difficulty of biliary cannulation were also compared, and there was also no significant difference (Table 1). Success rate of first-attempt cannulation after DWT and TPS procedures was 62.0% and 81.0%, respectively (P = 0.00; Table 2). Overall cannulation success rate was similar between the groups (86.9% vs 90.8%, P = 0.09). Success rate was 88.9% (240/270) in native papilla cannulation and 88.9% (8/9) in papilla with previous endoscopic sphincterotomy. Cannulation time in the DWT group was 7.8 ± 1.7 min compared with 3.7 ± 2.3 min in the TPS group (P = 0.00).
Complications Overall complications occurred in three cases in the DWT group and in 10 cases in the TPS group (2.2% vs 7.0%, P = 0.04; Table 2). The overall incidence of cholangitis, pancreatitis, hemorrhage and perforation was 1.1%, 1.8%, 1.1% and 0.4%, respectively. There was no significant difference in the rate of each type of complication between cannulation techniques. As for patients with successful native papilla cannulation using the standard cannulation technique, one case (1.2%) developed cholangitis and the other case (1.2%) developed mild pancreatitis. Total complications of successful native papilla cannulation using the standard cannulation technique revealed no significant difference compared with the DWT procedure (2.38% vs 2.19, P = 0.35) and the TPS procedure (2.38% vs 7.04%, P = 0.08). The most severe complication in ERCP procedures was pancreatitis, which occurred in one case (0.73 %) in the DWT group versus four cases (2.82 %) in the TPS group; no statistically significant difference was found (P = 0.16). Five patients developed PEP and all patients recovered after medical treatment. One patient had hypoxia and died soon after emergency measures. One patient received surgical management after perforation and was discharged 25 days after the operation.
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Table 1 Clinical characteristics of patients undergoing ERCP Data Gender Male Female Age (years, mean ± SD) Surgical history and ERCP, n (%) Cholecystectomy Sphincterotomy Billroth II gastrectomy Procedure, n (%) Elective Emergency Indications, n (%) Choledocholithiasis Biliary stricture CBD cancer Pancreatic cancer Gallbladder cancer Papillary duodenal cancer Biliary leak Biliary pancreatitis SOD Miscellaneous Factors affecting cannulation Peripapillary duodenal diverticulum Billroth II gastrectomy Previous endoscopic sphincterotomy
All patients
DWT, n (%)
TPS, n (%)
P-value
135 144 60.8 (10.4)
61 76 59.3 (18.2)
74 68 62.7 (15.7)
0.20 0.20 0.34
73 (26.2) 5 (1.8) 1 (0.4)
32 (23.4) 2 (1.5) 0
41 (28.9) 3 (2.1) 1 (0.7)
0.06 0.32 0.51
271 (97.1) 8 (2.9)
134 (97.8) 3 (2.2)
137 (96.5) 5 (3.5)
0.23 0.23
120 (43.0) 7 (2.5) 26 (9.3) 20 (7.2) 13 (4.7) 21 (7.5) 8 (2.9) 33 (11.8) 11 (3.9) 20 (7.2)
59 (43.1) 4 (2.9) 12 (8.8) 9 (6.6) 6 (4.4) 10 (7.3) 5 (3.6) 15 (10.9) 6 (4.4) 11 (8.0)
61 (43.0) 3 (2.1) 14 (9.9) 11 (7.7) 7 (4.9) 11 (7.7) 3 (2.1) 18 (12.7) 5 (3.5) 9 (6.3)
0.97 0.27 0.16 0.17 0.22 0.18 0.21 0.13 0.23 0.16
34 (12.2) 1 (0.4) 9 (3.2)
16 (11.7) 0 5 (3.6)
18 (12.7) 1 (0.7) 4 (2.8)
0.14 0.51 0.24
CBD, common bile duct; DWT, double-guidewire technique; ERCP, endoscopic retrograde cholangiopancreatography; SOD, sphincter of Oddi dysfunction; TPS, transpancreatic sphincterotomy.
Table 2 Success and complication rates of DWT and TPS for difficult biliary cannulation Data
Native papilla cannulation with SCT, n (%)
DWT, n (%)
TPS, n (%)
P-value (DWT vs TPS)
Initial attempt Overall success of cannulation Average time to cannulation, mean (SD) Total complications Cholangitis Pancreatitis Hemorrhage Perforation Death Pancreatitis severity Mild Moderate Severe
75 (89.3)*† 84 (100.0)* 5.6 (1.3)*† 2 (2.38) 1 (1.19) 1 (1.19) 0 0 0
85 (62.0) 119 (86.9) 7.8 (1.7) 3 (2.19) 1 (0.73) 1 (0.73) 0 1 (0.73) 0
115 (81.0) 129 (90.8) 3.7 (2.3) 10 (7.04) 2 (1.41) 4 (2.82) 3 (2.11) 0 1 (0.70)
0.00 0.09 0.00 0.04 0.38 0.16 0.13 0.49 0.51
1 (0.73) 0 0
2 (1.41) 2 (1.41) 0
0.38 0.26 NA
1 (1.19) 0 0
*Compared with DWT, P < 0.05. † Compared with TPS, P < 0.05. DWT, double-guidewire technique; NA, not applicable; SCT, standard cannulation technique; SD, standard deviation; TPS, transpancreatic sphincterotomy.
© 2014 The Authors Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society
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DISCUSSION
N
OWADAYS, LITTLE IS found in the literature with respect to the success of cannulation and complications of the varying cannulation techniques. To our knowledge, the present study is the first comparison between DWT and TPS techniques regarding the success rate and complications. Grade of cannulation difficulty for a given ERCP procedure may differ when different methods are used, so the question of how to evaluate the grade of cannulation difficulty has remained.14 However, time to cannulation is a more objective and more accurate assessment tool for grading cannulation difficulty than the number of attempts, so we recorded data of cannulation time in order to evaluate the difficulty of different methods.15 Selective cannulation of CBD can be difficult, so multiple strategies have been developed to overcome this situation. It is important to have in mind that the goal of all techniques is to decrease the rate of PEP.16 Some risk factors associated with PEP have been found, and new techniques to prevent PEP have been revealed. Placement of prophylactic pancreatic stents may lower the incidence of PEP in high-risk patients and alleviate the severity of this condition.17 The guidewire-assisted cannulation technique increased the primary cannulation rate and reduced the risk of PEP, and therefore appeared to be the most appropriate first-line cannulation technique.18–20 In most cases, standard biliary cannulation was the initial attempt to achieve deep cannulation; however, even the most experienced endoscopists occasionally failed to cannulate the CBD by this standard technique. The precut technique was the most commonly used approach for difficult biliary cannulation as it could be conducted conveniently during the initial ERCP procedure.21,22 There are many studies concerning precut sphincterotomy techniques that suggest precut sphincterotomy could increase the success rate of biliary cannulation.23 TPS technique is a relatively new precut technique among the various precut techniques, which was first described in 1995. Previous studies have found that TPS is a safe and effective procedure in patients with difficult bile duct access.24 However, the use of the precut technique for achieving deep cannulation of the bile duct is not recommended for inexperienced endoscopists as it is claimed to increase post-ERCP complications.25 Compared to standard cannulation, DWT may replace standard cannulation or become the salvage procedure in cases of unsuccessful biliary cannulation as a result of its high success rate with an acceptable incidence of PEP.26,27 For patients with periampullary duodenal diverticulum, DWT may offer a safe and effective method in biliary cannulation compared to TPS.28
In our study, the initial success rate of TPS at first ERCP attempt (81.0%) was higher than DWT (62.0%), and the difference between the two procedures was statistically significant (P = 0.00). However, the overall success rate between the TPS and DWT groups was 90.8% and 86.9% respectively, and there was no significant difference between them. As the definition of the initial attempt was less than 10 min, the long cannulation time for DWT may be one possible reason resulting in this outcome. Early studies reported DWT resulted in a significant reduction in unintentional pancreatic cannulation but did not translate into a reduction in pancreatitis.29 However, in terms of PEP, the results in the present study revealed a similar adverse event rate between the DWT procedure and the TPS procedure. Considering the differences between the two techniques, the static guidewire positioned temporarily in the pancreatic duct could not increase the risk of PEP. However, as in the DWT procedure, the TPS procedure also need not unintentionally avoid pancreatic duct cannulation. Thus, compared to DWT, an exchange accessory, including the needle knife or other wire, was not required and the procedure was carried out with a standard traction sphincterotome and was easy to control.30 However, the precut sphincterotomy technique was associated with a risk of post-ERCP complications, especially ERCP-induced pancreatitis.31 It is assumed that PEP is related to a prolonged period of pancreatic cannulation and repeated pancreatic cannulation attempts.32 As is widely known, complications after ERCP can be attributed to several factors, including endoscopist skill and technique, but how to improve cannulation techniques in order to avoid postoperative complications has remained a problem.33,34 In our study, the incidence of complications after the DWT and TPS procedures was 2.2% and 7.0%, respectively. The incidence of PEP after the procedures was 0.7% and 2.8%, respectively. In terms of complications, the precut procedure should be reserved by experts in high-risk patients with a strong indication for sphincterotomy when the standard technique fails. Meanwhile, the DWT group revealed a lower complication rate compared to the TPS group. There are some limitations of the present study. First, this study was a retrospective and single-center investigation. This means it contains accidental errors (small mistakes of the operator, distribution of various kinds of diseases etc.) and biases. Second, this was a comparative study, and not a rigorous randomized controlled trial. Therefore, the risk of bias exists in some parts of our investigation, and this could lead to bias of outcome to some extent. However, despite the preliminary limitation of these problems, the present study would be more consummate if we consider the following.
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First, a randomized controlled trial concerning DWT and TPS techniques is needed to provide more evidence. Second, more centers could join the study and share their information. Finally, information about hospital charges and hospital stays could be collected. In summary, the DWT and the TPS procedures are safe and effective for difficult biliary cannulation. The overall cannulation rate was similar between the groups. Although the DWT technique had a longer cannulation time, DWT could be considered as the preferred technique in patients with failed standard cannulation for a lower adverse event rate.
Digestive Endoscopy 2015; 27: 381–387
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ACKNOWLEDGMENT
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E WOULD LIKE to acknowledge the support of the Department of No. 1 Surgery, The First Hospital Affiliated to Anhui Chinese Medical University, Hefei, China.
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CONFLICT OF INTERESTS
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UTHORS DECLARE NO conflict of interests for this article. 15
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troscope for patients with Billroth II Gastrectomy. Gastroenterol. Res. Pract. 2013; 2013: 146867. Swahn F, Nilsson M, Arnelo U, Löhr M, Persson G, Enochsson L. Rendezvous cannulation technique reduces post-ERCP pancreatitis: a prospective nationwide study of 12,718 ERCP procedures. Am. J. Gastroenterol. 2013; 108: 552–9. Swahn F, Regnér S, Enochsson L et al. Endoscopic retrograde cholangiopancreatography with rendezvous cannulation reduces pancreatic injury. World J. Gastroenterol. 2013; 19: 6026–34. Gyokeres T, Duhl J, Varsanyi M et al. Double guide wire placement for endoscopic pancreaticobiliary procedures. Endoscopy 2003; 35: 95–6. Noel R, Enochsson L, Swahn F et al. A 10-year study of rendezvous intraoperative endoscopic retrograde cholangiography during cholecystectomy and the risk of post-ERCP pancreatitis. Surg. Endosc. 2013; 27: 2498–503. Cotton PB, Lehman G, Vennes J et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest. Endosc. 1991; 37: 383–93. Tian C, Gamboa A, Chaudhury B, Willingham FF, Keilin S, Cai Q. Cannulation time is a more accurate measure of cannulation difficulty in endoscopic retrograde cholangiopancreatography than the number of attempts. Gastroenterol. Rep. (Oxf.) 2013; 1: 193–7. Ozaslan E, Ozaslan NG, Purnak T, Ozkaya G. The impact of sphincterotome design on selective cannulation of the common bile duct. J. Gastroenterol. Hepatol. 2013; 28: 1573–7. Artifon EL, Moura RN, Otoch JP. Difficult cannulation: what should I do before EUS guided access? Rev. Gastroenterol. Peru. 2014; 34: 53–7. Shi QQ, Ning XY, Zhan LL, Tang GD, Lv XP. Placement of prophylactic pancreatic stents to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients: A meta-analysis. World J. Gastroenterol. 2014; 20: 7040–48. Tse F, Yuan Y, Moayyedi P, Leontiadis GI. Guide wire-assisted cannulation for the prevention of post-ERCP pancreatitis: a systematic review and meta-analysis. Endoscopy 2013; 45: 605– 18. Tanaka R, Itoi T, Sofuni A et al. Is the double-guidewire technique superior to the pancreatic duct guidewire technique in cases of pancreatic duct opacification? J. Gastroenterol. Hepatol. 2013; 28: 1787–93. Inoue H, Yamada R, Takei Y. Double guidewire in one catheter’ method for a difficult endoscopic retrograde cholangiopancreatography cannulation (with video). Dig. Endosc. 2013; 25: 550– 51. Zhang QS, Han B, Xu JH, Bao WM, Tao JL, Zhang Y. Needle knife precut papillotomy and fistulotomy for difficult biliary cannulation during endoscopic retrograde cholangiopancreatography. Digestion 2013; 88: 95–100. Zhu JH, Liu Q, Zhang DQ, Feng H, Chen WC. Evaluation of early precut with needle-knife in difficult biliary cannulation during ERCP. Dig. Dis. Sci. 2013; 58: 3606–10.
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23 Kobayashi G, Fujita N, Imaizumi K et al. Wire-guided biliary cannulation technique does not reduce the risk of post-ERCP pancreatitis: multicenter randomized controlled trial. Dig. Endosc. 2013; 25: 295–302. 24 Choudhary A, Winn J, Siddique S et al. Effect of precut sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review and meta-analysis. World J. Gastroenterol. 2014; 20: 4093–101. 25 Webb K, Saunders M. Endoscopic management of malignant bile duct strictures. Gastrointest. Endosc. Clin. N. Am. 2013; 23: 313–31. 26 Ito K, Horaguchi J, Fujita N et al. Clinical usefulness of doubleguidewire technique for difficult biliary cannulation in endoscopic retrograde cholangiopancreatography. Dig. Endosc. 2014; 26: 442–9. 27 Takenaka M, Fujita T, Sugiyama D et al. What is the most adapted indication of prophylactic pancreatic duct stent within the high-risk group of post-endoscopic retrograde cholangiopancreatography pancreatitis? Using the propensity score analysis. J. Hepatobiliary Pancreat. Sci. 2014; 21: 275–80. 28 Mohammad Alizadeh AH, Afzali ES, Shahnazi A et al. ERCP features and outcome in patients with periampullary duodenal diverticulum. ISRN Gastroenterol. 2013; 2013: 217261.
29 Chandran S, Nikfarjam M. The utility of upfront double wire guided biliary cannulation following early unintentional pancreatic cannulation in patients undergoing ERCP. Indian J. Gastroenterol. 2013; 32: 324–9. 30 Liu F, Liu J, Li Z. New role of the dual knife for precut papillotomy in difficult bile duct cannulation. Dig. Endosc. 2013; 25: 329–32. 31 Baron TH, Irani S. Prevention of post-ERCP pancreatitis. Minerva Med. 2014; 105: 129–36. 32 DiMagno MJ, Spaete JP, Ballard DD, Wamsteker EJ, Saini SD. Risk models for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP): smoking and chronic liver disease are predictors of protection against PEP. Pancreas 2013; 42: 996–1003. 33 Katsinelos P, Lazaraki G, Chatzimavroudis G et al. Risk factors for therapeutic ERCP-related complications: an analysis of 2,715 cases performed by a single endoscopist. Ann. Gastroenterol. 2014; 27: 65–72. 34 Liao YS, Zhao Q, Fan Y, Wu J. Proximal migration of a 5 French pancreatic stent during bile stone extraction: A successful retrieval using mini-snare. Niger. J. Clin. Pract. 2014; 17: 384–6.
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doi: 10.1111/den.12387
Original Article
Comparison between double-guidewire technique and transpancreatic sphincterotomy technique for difficult biliary cannulation Long Huang, Qing-sheng Yu, Qi Zhang, Ju-da Liu and Zhen Wang Department of No. 1 Surgery, The First Hospital Affiliated to Anhui Chinese Medical University, Hefei, China Background and Aim: The aim of the present study was to compare the effectiveness and complications of the doubleguidewire technique (DWT) with the transpancreatic sphincterotomy (TPS) technique. Methods: From January 2013 to December 2014, 366 consecutive endoscopic retrograde cholangiopancreatography (ERCP) procedures were carried out. Of 366 procedures, 354 procedures were carried out in patients with native major papilla biliary cannulation. A total of 279 consecutive therapeutic ERCP were included in the study and data of included patients were collected retrospectively. One hundred and thirty-seven procedures (49.1%) were done with DWT and 142 procedures (50.9%) were done with TPS for patients with difficult cannulation. The results and complications of ERCP were compared. Results: Success rate of first-attempt cannulation was 62.0% in the DWT group and 81.0% in the TPS group (P = 0.00). Final rate of
INTRODUCTION
S
ELECTIVE CANNULATION OF the biliary duct is the most important step for successful treatment of biliary tract diseases during endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, despite various accessory devices, the standard biliary cannulation technique has been reported to fail in approximately 5–20% cases.1 As the technique developed, several supplementary techniques have been recommended to facilitate access to the common bile duct (CBD) in cases of standard biliary cannulation failure. These are known to significantly increase not only the success rate of selective biliary cannulation but also the complication rate.2
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Corresponding: Long Huang, Department of No. 1 Surgery, The First Hospital Affiliated to Anhui Chinese Medical University, no. 117 Meishan Road, Hefei 230031, Anhui Province, China. Email: [email protected] Received 12 June 2014; accepted 22 September 2014.
successful cannulation of the two biliary cannulation techniques was 86.9% and 90.8%, respectively (P = 0.09). Cannulation time in the DWT group was 7.8 ± 1.7 min compared with 3.7 ± 2.3 min in the TPS group (P = 0.00). Overall incidence of post-ERCP pancreatitis (PEP), hemorrhage, perforation and cholangitis was 1.8%, 1.1%, 0.4% and 1.1%, respectively. Adverse event rate was 2.19% in the DWT group and 7.04% in the TPS group (P = 0.04).
Conclusions: DWT and TPS procedures were safe and effective. Overall cannulation rate was similar between the groups. Although DWT had a longer cannulation time, it could be considered the preferred technique in patients with failed standard cannulation for lower adverse event rate. Keywords: biliary cannulation, complication, double-guidewire technique, endoscopic retrograde cholangiopancreatography (ERCP), precut technique
Commonly, a precutting technique is used to allow biliary access when the standard cannulation technique failed. There are three types of precutting technique: needle-knife papillotomy, suprapapillary fistulotomy and transpancreatic sphincterotomy (TPS). In terms of effectiveness and efficiency of the precutting technique, TPS, which need not avoid pancreatic duct cannulation unintentionally, is an effective method especially for difficult biliary cannulation.3 Furthermore, more advanced techniques have also been developed to aid biliary access if it is unsuccessful with standard devices.4 For surgically altered gastrointestinal anatomy, some special skills should be considered.5,6 Enterography route, which crosses the greater curvature of the stomach and the ‘lower entrance’ at the site of the gastrojejunal anastomosis, along the efferent loop, and goes through the ‘middle entrance’ at the site of the Braun anastomosis to reach Vater’s papilla, is optimal for patients with Billroth II gastroenterostomy and Braun anastomosis.7,8 For patients with cholecystolithiasis and choledocholithiasis, the rendezvous technique is appropriate, accompanied by laparoscopic cholecystectomy.9 Rendezvous technique can
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reduce pancreatic enzyme leakage compared with conventional ERCP cannulation technique.10 In 2003, the early double-guidewire technique (DWT) was reported in the adult literature for cases associated with low complication and high success rates.11 In terms of DWT procedure, this technique is a useful aid for the endoscopist attempting to selectively cannulate the CBD in difficult cases. Further study will be needed to establish the safety of advanced techniques in the pediatric population.12 However, there is no consensus on the type of advanced techniques to achieve safe and successful CBD cannulation. This may be because of multiple confused attempts to achieve CBD cannulation causing excess edema and papillary trauma. What is the best treatment strategy if the pancreatic duct is repeatedly unintentionally cannulated with the guidewire and biliary cannulation is not achieved? The DWT and TPS procedures are all suitable for this situation. So far, data on advanced techniques are still limited. The aim of this retrospective study was to compare the results and complications of DWT with TPS for difficult biliary cannulation in a study with a large number of subjects.
METHODS Patients and techniques
A
T ANHUI CHINESE Medical Research Institute of Surgery, 366 consecutive endoscopic retrograde cholangiopancreatography (ERCP) procedures were carried out (Fig. 1). Of 366 procedures, 354 procedures were done in patients with native major papilla biliary cannulation. A total of 279 consecutive therapeutic ERCP procedures using the DWT or TPS technique by one experienced endoscopist from January 2012 to December 2013 were carried out. The most suitable cannulation technique for included patients was selected by the endoscopist according to the major papilla. Patients were excluded if they had any other cannulation techniques, such as needle knife sphincterotomy, except DWT and TPS techniques. Eighty-seven ERCP procedures with successful standard biliary cannulation or diagnostic ERCP procedures were excluded. All clinical data were collected in the study. Before ERCP, all patients or their relatives provided informed consent and the investigation was carried out in accordance with the principles of the Helsinki Declaration of 1975, as revised in 2013. The Institutional Review Board of the Anhui Provincial Traditional Chinese Hospital approved the study protocol. All included patients were classified into two groups: double-guidewire technique group (DWT) and transpancreatic sphincterotomy group (TPS) according to the method
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ERCP procedures (n = 366) Native major papilla biliary cannulation (n = 354)
Patients received endoscopic sphincterotomy before admission (n = 12)
Native major papilla using DWT or TPS (n = 270)
Patients with previous endoscopic sphincterotomy using DWT or TPS (n = 9)
ERCP using DWT or TPS technique (n = 279)
DWT Received (n = 137)
TPS Received (n = 142)
Total success cannulation (n = 119) Complication (n = 3)
Total success cannulation (n = 129) Complication (n = 10)
Figure 1 Flow diagram of endoscopic retrograde cholangiopancreatography (ERCP) procedures. DWT, double-guidewire technique; TPS, transpancreatic sphincterotomy.
of biliary cannulation. All ERCP procedures were done using an Olympus video duodenoscope (JF-260V; Olympus Corporation, Tokyo, Japan). All cases were started with a standard ERCP catheter (double lumen sphincterotome, Ultratome XL; Boston Scientific, Natick, MA, USA) preloaded with contrast. A guidewire (0.035-inch Jagwire; Boston Scientific, Miami, FL, USA) was used to aid biliary cannulation (initial standard cannulation). However, if biliary cannulation failed after 10 min and the pancreatic duct was repeatedly unintentionally cannulated with the guidewire, supplementary cannulation techniques (including DWT and TPS) were used. The TPS procedure was applied with the Endocut mode in the ERBE system (120 W cut; 15 W coagulation; ERBE USA, Atlanta, GA, USA), which automatically adjusts the amount of cutting and coagulating current, depending on the tissue resistance. Also, the ERBE settings were used for all sphincterotomies. Sedation for the procedures consisted of a combination of meperidine and diazepam with raceanisodamine as needed for duodenal relaxation. Treatment for patients with biliary obstruction, such as common bile duct cancer, pancreatic cancer or biliary stricture, was placement of a stent with planned exchanges every 3–6 months. For the purpose of preventing post-ERCP pancreatitis (PEP), pancreatic stent was not placed conventionally unless the pancreatic duct was cannulated more than five times.
© 2014 The Authors Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society
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Surgery techniques
RESULTS
Double-guidewire technique was carried out with a guidewire inserted into the pancreatic duct. Then, with the former wire positioned in the pancreatic duct, the sphincterotome catheter was exchanged off the pancreatic duct guidewire and reintroduced down the endoscopic channel alongside it. The second wire was inserted at the ampullary orifice above the former pancreatic wire in the 11 o’clock direction. Finally, attempt at biliary cannulation was undertaken. TPS was conducted as follows. A guidewire was inserted deeply into the pancreatic duct; then a standard traction sphincterotome was wedged into the pancreatic orifice, and the sphincterotomy was carried out with a cutting wire along the biliary direction at 11 o’clock. The incision was made through the septum between the pancreatic and biliary duct with the aim of exposing the bile duct orifice. After transpancreatic sphincterotomy, attempt at biliary cannulation was undertaken.
B
Definition of outcomes Successful initial cannulation using standard cannulation technique was defined as free and deep placement of the sphincterotome into the CBD within 10 min. Standard cannulation was said to have failed when the bile duct was not cannulated after multiple attempts on the papilla. Changing to different cannulas and sphincterotomes could be used during the standard cannulation technique according to the endoscopist’s experience. All 279 patients included in this study had failed cannulation using the standard cannulation technique. The overall success rate was defined as eventual successful biliary cannulation. Cannulation time was measured from the time the cannulating device was inserted into the endoscopic channel to free and deep cannulation of the CBD. Definitions of complications after ERCP procedures were the same as those reported by Cotton et al.13 All included patients were contacted by telephone and specifically questioned regarding postoperative complications after ERCP procedures. All data of included patients were recorded in detail.
Data analysis Statistical analysis was done using Statistical Package for the Social Sciences (SPSS, Version 13.0, Chicago, IL, USA). Continuous variables were reported as means ± standard deviation (SD) or ranges. Comparison between groups was carried out using the t-test for measurement data and using χ2-test with or without Fisher’s exact test for categorical variables. Statistical significance was accepted at the 5% level by a two tailed test.
ETWEEN JANUARY 2012 and December 2013, a total of 366 ERCP procedures were carried out by one experienced endoscopist. Eighty-seven ERCP procedures with successful standard biliary cannulation or diagnostic ERCP procedures were excluded. Of the 87 procedures, 84 were native papillas, and three had previous endoscopic sphincterotomies or interventions. Of 279 ERCP procedures (135 male, 144 female; mean age 60.8 years) included in the study, 137 procedures were classified in the DWT group and 142 procedures were classified in the TPS group. Characteristics of the DWT and TPS groups are summarized in Table 1. A total of nine cases received endoscopic sphincterotomy before admission. There was no statistically significant difference between the two groups for any of these parameters. Factors affecting the difficulty of biliary cannulation were also compared, and there was also no significant difference (Table 1). Success rate of first-attempt cannulation after DWT and TPS procedures was 62.0% and 81.0%, respectively (P = 0.00; Table 2). Overall cannulation success rate was similar between the groups (86.9% vs 90.8%, P = 0.09). Success rate was 88.9% (240/270) in native papilla cannulation and 88.9% (8/9) in papilla with previous endoscopic sphincterotomy. Cannulation time in the DWT group was 7.8 ± 1.7 min compared with 3.7 ± 2.3 min in the TPS group (P = 0.00).
Complications Overall complications occurred in three cases in the DWT group and in 10 cases in the TPS group (2.2% vs 7.0%, P = 0.04; Table 2). The overall incidence of cholangitis, pancreatitis, hemorrhage and perforation was 1.1%, 1.8%, 1.1% and 0.4%, respectively. There was no significant difference in the rate of each type of complication between cannulation techniques. As for patients with successful native papilla cannulation using the standard cannulation technique, one case (1.2%) developed cholangitis and the other case (1.2%) developed mild pancreatitis. Total complications of successful native papilla cannulation using the standard cannulation technique revealed no significant difference compared with the DWT procedure (2.38% vs 2.19, P = 0.35) and the TPS procedure (2.38% vs 7.04%, P = 0.08). The most severe complication in ERCP procedures was pancreatitis, which occurred in one case (0.73 %) in the DWT group versus four cases (2.82 %) in the TPS group; no statistically significant difference was found (P = 0.16). Five patients developed PEP and all patients recovered after medical treatment. One patient had hypoxia and died soon after emergency measures. One patient received surgical management after perforation and was discharged 25 days after the operation.
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Table 1 Clinical characteristics of patients undergoing ERCP Data Gender Male Female Age (years, mean ± SD) Surgical history and ERCP, n (%) Cholecystectomy Sphincterotomy Billroth II gastrectomy Procedure, n (%) Elective Emergency Indications, n (%) Choledocholithiasis Biliary stricture CBD cancer Pancreatic cancer Gallbladder cancer Papillary duodenal cancer Biliary leak Biliary pancreatitis SOD Miscellaneous Factors affecting cannulation Peripapillary duodenal diverticulum Billroth II gastrectomy Previous endoscopic sphincterotomy
All patients
DWT, n (%)
TPS, n (%)
P-value
135 144 60.8 (10.4)
61 76 59.3 (18.2)
74 68 62.7 (15.7)
0.20 0.20 0.34
73 (26.2) 5 (1.8) 1 (0.4)
32 (23.4) 2 (1.5) 0
41 (28.9) 3 (2.1) 1 (0.7)
0.06 0.32 0.51
271 (97.1) 8 (2.9)
134 (97.8) 3 (2.2)
137 (96.5) 5 (3.5)
0.23 0.23
120 (43.0) 7 (2.5) 26 (9.3) 20 (7.2) 13 (4.7) 21 (7.5) 8 (2.9) 33 (11.8) 11 (3.9) 20 (7.2)
59 (43.1) 4 (2.9) 12 (8.8) 9 (6.6) 6 (4.4) 10 (7.3) 5 (3.6) 15 (10.9) 6 (4.4) 11 (8.0)
61 (43.0) 3 (2.1) 14 (9.9) 11 (7.7) 7 (4.9) 11 (7.7) 3 (2.1) 18 (12.7) 5 (3.5) 9 (6.3)
0.97 0.27 0.16 0.17 0.22 0.18 0.21 0.13 0.23 0.16
34 (12.2) 1 (0.4) 9 (3.2)
16 (11.7) 0 5 (3.6)
18 (12.7) 1 (0.7) 4 (2.8)
0.14 0.51 0.24
CBD, common bile duct; DWT, double-guidewire technique; ERCP, endoscopic retrograde cholangiopancreatography; SOD, sphincter of Oddi dysfunction; TPS, transpancreatic sphincterotomy.
Table 2 Success and complication rates of DWT and TPS for difficult biliary cannulation Data
Native papilla cannulation with SCT, n (%)
DWT, n (%)
TPS, n (%)
P-value (DWT vs TPS)
Initial attempt Overall success of cannulation Average time to cannulation, mean (SD) Total complications Cholangitis Pancreatitis Hemorrhage Perforation Death Pancreatitis severity Mild Moderate Severe
75 (89.3)*† 84 (100.0)* 5.6 (1.3)*† 2 (2.38) 1 (1.19) 1 (1.19) 0 0 0
85 (62.0) 119 (86.9) 7.8 (1.7) 3 (2.19) 1 (0.73) 1 (0.73) 0 1 (0.73) 0
115 (81.0) 129 (90.8) 3.7 (2.3) 10 (7.04) 2 (1.41) 4 (2.82) 3 (2.11) 0 1 (0.70)
0.00 0.09 0.00 0.04 0.38 0.16 0.13 0.49 0.51
1 (0.73) 0 0
2 (1.41) 2 (1.41) 0
0.38 0.26 NA
1 (1.19) 0 0
*Compared with DWT, P < 0.05. † Compared with TPS, P < 0.05. DWT, double-guidewire technique; NA, not applicable; SCT, standard cannulation technique; SD, standard deviation; TPS, transpancreatic sphincterotomy.
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DISCUSSION
N
OWADAYS, LITTLE IS found in the literature with respect to the success of cannulation and complications of the varying cannulation techniques. To our knowledge, the present study is the first comparison between DWT and TPS techniques regarding the success rate and complications. Grade of cannulation difficulty for a given ERCP procedure may differ when different methods are used, so the question of how to evaluate the grade of cannulation difficulty has remained.14 However, time to cannulation is a more objective and more accurate assessment tool for grading cannulation difficulty than the number of attempts, so we recorded data of cannulation time in order to evaluate the difficulty of different methods.15 Selective cannulation of CBD can be difficult, so multiple strategies have been developed to overcome this situation. It is important to have in mind that the goal of all techniques is to decrease the rate of PEP.16 Some risk factors associated with PEP have been found, and new techniques to prevent PEP have been revealed. Placement of prophylactic pancreatic stents may lower the incidence of PEP in high-risk patients and alleviate the severity of this condition.17 The guidewire-assisted cannulation technique increased the primary cannulation rate and reduced the risk of PEP, and therefore appeared to be the most appropriate first-line cannulation technique.18–20 In most cases, standard biliary cannulation was the initial attempt to achieve deep cannulation; however, even the most experienced endoscopists occasionally failed to cannulate the CBD by this standard technique. The precut technique was the most commonly used approach for difficult biliary cannulation as it could be conducted conveniently during the initial ERCP procedure.21,22 There are many studies concerning precut sphincterotomy techniques that suggest precut sphincterotomy could increase the success rate of biliary cannulation.23 TPS technique is a relatively new precut technique among the various precut techniques, which was first described in 1995. Previous studies have found that TPS is a safe and effective procedure in patients with difficult bile duct access.24 However, the use of the precut technique for achieving deep cannulation of the bile duct is not recommended for inexperienced endoscopists as it is claimed to increase post-ERCP complications.25 Compared to standard cannulation, DWT may replace standard cannulation or become the salvage procedure in cases of unsuccessful biliary cannulation as a result of its high success rate with an acceptable incidence of PEP.26,27 For patients with periampullary duodenal diverticulum, DWT may offer a safe and effective method in biliary cannulation compared to TPS.28
In our study, the initial success rate of TPS at first ERCP attempt (81.0%) was higher than DWT (62.0%), and the difference between the two procedures was statistically significant (P = 0.00). However, the overall success rate between the TPS and DWT groups was 90.8% and 86.9% respectively, and there was no significant difference between them. As the definition of the initial attempt was less than 10 min, the long cannulation time for DWT may be one possible reason resulting in this outcome. Early studies reported DWT resulted in a significant reduction in unintentional pancreatic cannulation but did not translate into a reduction in pancreatitis.29 However, in terms of PEP, the results in the present study revealed a similar adverse event rate between the DWT procedure and the TPS procedure. Considering the differences between the two techniques, the static guidewire positioned temporarily in the pancreatic duct could not increase the risk of PEP. However, as in the DWT procedure, the TPS procedure also need not unintentionally avoid pancreatic duct cannulation. Thus, compared to DWT, an exchange accessory, including the needle knife or other wire, was not required and the procedure was carried out with a standard traction sphincterotome and was easy to control.30 However, the precut sphincterotomy technique was associated with a risk of post-ERCP complications, especially ERCP-induced pancreatitis.31 It is assumed that PEP is related to a prolonged period of pancreatic cannulation and repeated pancreatic cannulation attempts.32 As is widely known, complications after ERCP can be attributed to several factors, including endoscopist skill and technique, but how to improve cannulation techniques in order to avoid postoperative complications has remained a problem.33,34 In our study, the incidence of complications after the DWT and TPS procedures was 2.2% and 7.0%, respectively. The incidence of PEP after the procedures was 0.7% and 2.8%, respectively. In terms of complications, the precut procedure should be reserved by experts in high-risk patients with a strong indication for sphincterotomy when the standard technique fails. Meanwhile, the DWT group revealed a lower complication rate compared to the TPS group. There are some limitations of the present study. First, this study was a retrospective and single-center investigation. This means it contains accidental errors (small mistakes of the operator, distribution of various kinds of diseases etc.) and biases. Second, this was a comparative study, and not a rigorous randomized controlled trial. Therefore, the risk of bias exists in some parts of our investigation, and this could lead to bias of outcome to some extent. However, despite the preliminary limitation of these problems, the present study would be more consummate if we consider the following.
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First, a randomized controlled trial concerning DWT and TPS techniques is needed to provide more evidence. Second, more centers could join the study and share their information. Finally, information about hospital charges and hospital stays could be collected. In summary, the DWT and the TPS procedures are safe and effective for difficult biliary cannulation. The overall cannulation rate was similar between the groups. Although the DWT technique had a longer cannulation time, DWT could be considered as the preferred technique in patients with failed standard cannulation for a lower adverse event rate.
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ACKNOWLEDGMENT
W
E WOULD LIKE to acknowledge the support of the Department of No. 1 Surgery, The First Hospital Affiliated to Anhui Chinese Medical University, Hefei, China.
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CONFLICT OF INTERESTS
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UTHORS DECLARE NO conflict of interests for this article. 15
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