JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES Volume 24, Number 5, 2014 ª Mary Ann Liebert, Inc. DOI: 10.1089/lap.2013.0546
Full Reports
Laparoscopic Versus Endoscopic Management of Choledocholithiasis in Patients Undergoing Laparoscopic Cholecystectomy: A Meta-analysis Jun-guo Liu, MS,1 Yi-jun Wang, MS,1 Gui-ming Shu, PhD,1 Cheng Lou, PhD,1 Jinjuan Zhang, PhD,1 and Zhi Du, MD, PhD1,2
Abstract
Aim: To compare the clinical effectiveness of the treatment of choledocholithiasis by laparoscopic common bile duct (CBD) exploration and by endoscopic sphincterotomy (EST). Materials and Methods: A meta-analysis of studies about CBD stones was performed to analyze EST in comparison with laparoscopic CBD exploration procedures. Trials were identified by searching the Medline, EMBASE, PubMed, CBM, and CNKI databases from January 1990 to December 2012 for laparoscopic CBD exploration or EST for CBD stones. Results: Fifteen studies were identified in the meta-analysis. The incidence of bleeding or pancreatitis in the EST group was higher than that in the laparoscopic group. However, the incidence of bile leakage in the EST group was lower than that in the laparoscopic group. The differences in cases of retained stones or total complications were not statistically significant between the laparoscopic and EST groups (P > .05). There were more successful cases in the laparoscopic group than in the EST group (P < .05). Hospital cost was less in the laparoscopic group than in the EST group (P < .05). Mean operation time and hospital stay in the laparoscopic group were shorter than those in the EST group (P < .05). Conclusions: To some degree, laparoscopic treatment of the CBD may be a better way of removing stones than EST.
Introduction
C
ommon bile duct (CBD) stones are a common surgical disease. Traditional surgery, with a higher complication rate, is gradually being replaced by minimally invasive surgery. Minimally invasive surgery, which is a new user-friendly advanced surgical method, can effectively reduce or avoid surgical trauma and iatrogenic complications to the patient. Endoscopic sphincterotomy (EST) and laparoscopic CBD exploration (LCBDE), which are both minimally invasive treatments of CBD stones, are two main surgical procedures except for open surgery.1 Laparoscopic exploration of the CBD is becoming more popular, although EST remains the usual treatment for bile duct stones. However, loss of the biliary sphincter causes permanent duodenobiliary reflux, and recurrent stone disease and biliary neoplasia may be a consequence.2 In this article, we search the clinical literature on the application of laparoscopic and endoscopic treatment of CBD 1
stones, in China and abroad, and conduct systematic reviews. Using the evidence-based medicine method, 15 researched article in the clinical literature were examined in a metaanalysis in order to provide a more reasonable clinical basis for the clinical treatment options. Materials and Methods Search strategy and identification of studies
A literature search was performed in the following electronic databases (from January 1990 to December 2012): Medline, EMBASE, PubMed, CBM, and CNKI. The free-text search terms ‘‘common bile duct stone,’’ ‘‘endoscopic sphincterotomy (EST),’’ ‘‘laparoscopic,’’ and ‘‘complication’’ were used. Additionally, the citation lists of all relevant publications, review articles, and included studies were hand-searched. Language limitations in English and Chinese were applied.
Department of Surgery and 2Key Laboratory of Artificial Cells, Tianjin Third Central Hospital, Tianjin, China.
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In the case of overlap between two reports, only the most detailed report was included. Reports about treatments obtained with noncommercial electrodes and treatments with palliative intent (intentional partial debulking) were excluded. When appropriate, authors were contacted to obtain more details about the cases they reported. Data extraction and quality assessment
Data were extracted by three independent observers using standardized forms. The recorded data included the number of patients and complications.The quality of all selected articles was ranked in accordance with the score according to the randomized controlled clinical trial quality evaluation standard (Table 1). Study selection criteria
Inclusion criteria for this analysis were as follows: 1. All selected patients with CBD stones (with or without gallstones) 2. Studies about cases of retained stones, cases of successful clearance of stones, mean operation time, hospital stay, hospital cost, and complications (pancreatitis, bleeding, bile leakage and intestinal perforation, stone recurrence, duodenal papillary stenosis, stenosis of bile duct, reflux cholangitis) 3. Randomized controlled study with years of research carried out or published 4. Clear definition on the sample size, such as number of cases in the EST group and in the laparoscopic group 5. Specific details of the outcome parameters such as cases of retained stones, cases of successful clearance of stones, mean operation time, hospital stay, hospital cost, and complications 6. Based on laparoscopic surgical techniques (choledochoscope exploration, laparoscopic choledocholithotomy, and T-tube drainage) and EST-based surgical procedures 7. Randomized controlled study
Statistical analysis
The dichotomous data results for some of the studies eligible for meta-analysis were expressed as an odds ratio (OR) with 95% confidence intervals (CIs). These results were combined for meta-analysis using the Mantel–Haenszel model, when using the fixed-effects method, and the Der Simonian and Laird method, when using the random-effects method. When the outcome of interest was of continuous data, the differences were pooled across the studies, which provided information on this outcome parameter, resulting in a weighted mean difference (WMD) with 95% CI. The inverse variance method and the DerSimonian and Laird method were used when the fixed- or random-effects method, respectively, was applied. All results were combined for meta-analysis with Review Manager software (2003, Version 4.2 for Windows; The Nordic Cochrane Centre [Copenhagen, Denmark] and The Cochrane Collaboration [London, United Kingdom]). Studyto-study variation was assessed by using the chi-squared statistic (the hypothesis tested was that the studies are all drawn from the same population [i.e., from a population with the same effect size]). A fixed-effects model was used where no heterogeneity was present, whereas in the presence of significant heterogeneity, a random-effects model was applied. A funnel plot analysis and Egger’s test were performed in order to detect the presence of publication bias. Statistical significance was set at a P level of .05. Results Description of trials included in the meta-analysis
According to exclusion and selected criteria of historical data, 15 articles,3–17 including 7 articles3–7,15,16 from Chinese journals, were selected for meta-analysis, including 708 cases in the laparoscopic group and 702 patients in the EST group. The characteristics of the 15 clinical trials included are shown in Table 1. The total incidences of bile leakage in the EST and laparoscopic groups from eight
Table 1. Methodological Quality of Studies Included in the Meta-analysis Reference
Year
Country
Pi et al.3 Chen et al.4 Dai et al.5 Li6 Liao7 Rhodes et al.8 Nathanson et al.9 Cuschieri et al.10 Rogers et al.11 Noble et al.12 Sgourakis and Karaliotas13 Bansal et al.14 Li15 Shen and Chen16 EIGeidie et al.17
2008 2010 2010 2010 2010 1998 2005 1999 2010 2009 2002 2010 2012 2012 2011
China China China China China United Kingdom Australia United Kingdom United States United Kingdom Greece India China China Egypt
Quality evaluation scorea
Study design Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized
controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled
trial trial trial trial trial trial trial trial trial trial trial trial trial trial trial
3 3 3 3 3 5 5 5 5 5 4 5 3 3 4
a According to the quality of randomized controlled clinical trial evaluation criteria ( Jadad rating scale), a score of q3 indicates highquality research.
LAPAROSCOPIC VS. ENDOSCOPIC CHOLEDOCHOLITHIASIS
studies4–6,8–10,14,15 are, respectively, 0.5% (2 of 439) and 6.3% (28 of 445). Thus, total incidence of bile leakage in the EST group is lower. From six studies,3,8–11,14 the total incidence of bleeding in EST group was 3.7% (8 of 215), but there was none in the laparoscopic group. The total incidences of pancreatitis in the EST and laparoscopic groups from seven studies3–6,12,14,15 are, respectively, 3.6% (12 of 329) and 0.3% (1 of 348). Thus, the incidence of pancreatitis in the EST group is higher. Meta-analysis
Regarding successful cases of treatment, retained stone, total complication, mean operation time, hospital stay, and hospital cost, the laparoscopic group was compared with the EST group in the treatment of CBD stones by meta-analysis (Fig. 1). Successful cases (meaning the operation of each group was performed successfully). There were 13 trials. The chi-
squared test of heterogeneity was not significant (P = .31). Accordingly, a fixed-effect model was used. There was a difference in successful cases between the laparoscopic group (92.7%) and the EST group (89.1%) with a combined OR of 1.55 (95% CI, 1.04, 2.29; P = .03) (Fig. 1A). There were more successful cases in the laparoscopic group than in the EST group (P < .05). Cases of retained stones. There were 13 trials. The chisquared test of heterogeneity was not significant (P = .58). Accordingly, a fixed-effect model was used. There was no difference in the cases of retained stones between the laparoscopic group (5.1%) and the EST group (6%) with a combined OR of 0.87 (95% CI, 0.54, 1.39; P = .58) (Fig. 1B). Total complications. There were 15 trials. The chisquared test of heterogeneity was significant (P = .05). Accordingly, a random-effect model was used. There was no difference in the total complication rate between the laparoscopic group (15.4%) and the EST group (18.8%) with a combined OR of 0.88 (95% CI, 0.64, 1.2; P = .58) (Fig. 1C). Mean operation time (minutes). There were six trials. The chi-squared test of heterogeneity was not significant (P < .05). Accordingly, a random-effect model was used. Mean operation time in the laparoscopic group was shorter than that in the EST group (P < .05) with a WMD of - 61.84 (95% CI, - 114.42, - 9.26; P = .02) (Fig. 1D). Hospital stay (days). There were 12 trials. The chisquared test of heterogeneity was not significant (P < .05). Accordingly, a random-effect model was used. Hospital stay in the laparoscopic group was less than that in the EST group (P < .05) with a WMD of - 3.32 (95% CI, - 5.69, - 0.95; P < .05) (Fig. 1E). Hospital cost (10,000 yuan). There were only four trials from China. The chi-squared test of heterogeneity was not significant (P < .05). Accordingly, a random-effect model was used. Hospital cost in the laparoscopic group was less than that in the EST group (P < .05) with a WMD of - 0.55 (95% CI, - 0.97, - 0.13; P < .05) (Fig. 1F).
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Sensitivity analysis and publication bias
Publication bias may exist when no significant findings remain unpublished, thus artificially inflating the apparent magnitude of an effect. The outcome parameters from cases of retained stones, total complication, hospital stay, mean operation time, and hospital cost were calculated by the fixed-effect model or random-effect model, respectively. The results were similar, and the combined results were highly reliable. However, the result of successful cases was not similar and not reliable. Funnel plots of the study results are shown in Figure 2. The funnel plots for successful cases, cases of retained stones, total complication, hospital stay, and hospital cost following laparoscopic or EST treatment showed basic symmetry, which suggested no publication bias. However, the funnel plots on mean operation time showed publication bias. Discussion
Ludwig Courvoisier performed the first laparotomy for CBD surgery in Switzerland in 1889. Kawai in Japan and Classen and Demling in Germany first reported the first stone extraction through EST in 1974.18 With the continuous development of endoscopic techniques and instruments, traditional surgical concepts and technology have undergone tremendous change, and the concept of minimally invasive surgery is being developed and established. CBD stone extraction by duodenoscopy has become the primary method of treatment of CBD stones and has been recognized as the preferred method for most scholars. Endoscopic stone extraction is an ideal way to deal with residual bile duct stones and avoids re-operation. Other procedures for CBD stone extraction include percutaneous, transhepatic, and intraoperative CBD exploration, whether laparoscopic or open. The availability of equipment and skilled practitioners who are facile with these techniques varies among institutions. The timing of the intervention is often dictated by the clinical situation.19 Therefore, laparotomy CBD exploration is regarded as the last choice when endoscopic or laparoscopic treatment methods failed. Endoscopic surgery has more advantages than traditional surgery—no abdominal incision, the bile duct incision, less pain, faster recovery, walking after surgery immediately, and eating the same day—so it has become a rapidly popular surgical procedure and is widely applied. It should be noted that the Oddi sphincter is the important valve controlling bile and pancreatic juice discharge, and anatomic or functional abnormalities may lead to dysfunction. EST permanently damages Oddi sphincter function, with counterflow of intestinal contents and pancreatic juice into the biliary tract, and it may cause various chemical and bacterial inflammations, resulting in cholangitis.1 Recurrent biliary tract infection is an important pathogenic and precipitating factor in the process of stone formation. EST postoperative complications, such as serious potential bleeding, perforation, and pancreatitis, began to be of concern. From 1% to 3% of the complications required laparotomy, and the long-term postoperative complication rate of EST increased with time after surgery.20 The mortality rate from endoscopic retrograde
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FIG. 1. The fixed-effects model of odds ratio (OR) for (A) successful cases and (B) retained stone cases and the randomeffects model of (C) OR for complications and weighted mean difference (WMD) for (D) mean operation time, (E) hospital stay, and (F) hospital cost after treatment for the laparoscopic group versus the endoscopic sphincterotomy (EST) group. CI, confidence interval; SD, standard deviation. cholangiopancreatography (ERCP) is 0.2%–0.5%.21,22 Heili et al.18 reported a long-term postoperative CBD stone recurrence rate of EST of 2%–16%, acute cholangitis of 1%–6%, papillary stenosis of 1%–7%, etc. Therefore, the actual long-term complication rate after EST should be higher than the above values because some cases have not appeared during follow-up yet. Furthermore, CBD epi-
thelial hyperplasia, goblet cell metaplasia, and Helicobacter adenoid tissue formation can be caused by chronic inflammation, which may be the pathological basis of bile duct cancer lesions. We think it should be clarified that in some cases patients with choledocholithiasis have not yet undergone cholecystectomy, and this should be part of the discussion about hospital stay being longer in the ERCP
LAPAROSCOPIC VS. ENDOSCOPIC CHOLEDOCHOLITHIASIS
FIG. 1.
group. If a patient develops post-ERCP pancreatitis, for example, for which we found there is a higher likelihood of occurrence, his or her hospital stay is going to be longer as cholecystectomy will be delayed. This needs to be addressed if we are going to say one of the advantages of LCBDE is a shorter hospital stay. Laparoscopic biliary surgery is another important new minimally invasive technology. Jacobs, Petelin, Philips, and co-workers reported the experience of carrying out laparoscopic stone extraction in 1991, as recorded by Memon et al.23 The technology has become one of the common surgical methods in the treatment of CBD stones. Because there is no damage to Oddi sphincter function, retaining the integrity of the CBD, fewer complications appear after laparoscopic surgery, and complications of laparoscopic surgery are mild and can often be cured through nonsurgical treatment. Long-term follow-up does not demonstrate a significant risk of CBD stricture or other complications for these procedures.24–26 This technique is also advocated in
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(Continued).
the pediatric population by some practitioners as a way of avoiding an ERCP.27 Meta-analysis of these data has confirmed that the laparoscopic group has some advantages compared with the endoscopic group in successful clearance, mean operation time, hospital stay, and hospital cost. Therefore, we believe that in the treatment of CBD stones, laparoscopic treatment is more effective and more reasonable and should be the first choice for appropriate surgical cases. Although the success rate for stone clearance in isolated ERCP treatment is up to 87%–97%, up to 25% of patients require two or more ERCP treatments.28 This method is associated with morbidity and mortality rates of 5%–11% and 0.7%–1.2%, respectively.29,30 LCBDE was associated with successful stone clearance rates ranging from 85% to 95%, a morbidity rate from 4% to 16%, and a mortality rate of around 0%–2%.31,32 This meta-analysis cannot be stratified further according to other possible confounding factors; therefore, the conclusions
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FIG. 2. Funnel plots for comparison of the laparoscopic group versus the endoscopic sphincterotomy (EST) group: (A) 13 articles in the meta-analysis of successful cases of operation, (B) 13 articles in the meta-analysis of a retained stone, (C) 15 articles in the meta-analysis of complications, (D) 6 articles in the meta-analysis of mean operation time, (E) 12 articles in the meta-analysis of hospital stay, and (F) 4 articles in the meta-analysis of hospital cost. OR, odds ratio; SE, standard error; WMD, weighted mean difference. of this study need more detailed data to be confirmed. In our meta-analysis we only searched the Medline database, PubMed database, China Biological Medicine Database, and Chinese full-text database of academic journals, supplemented by retrospective literature, hand-searching, etc., but only in the English and Chinese languages. The sources of data are narrowed, and the integrity of information is
affected to some degree. Also, there is a reporting bias. But, according to these data and the literature, the laparoscopic group has more obvious advantages than the endoscopic group. At present, laparoscopic treatment of choledocholithiasis has been carried out for a short time, and small numbers of cases are reported. We expect a large sample of randomized controlled trials and reliable methodology to
LAPAROSCOPIC VS. ENDOSCOPIC CHOLEDOCHOLITHIASIS
determine the accuracy of the details of the results and, at the same time through literature updates, to improve the evaluation. Meanwhile, indicators are lack of uniform standards for evaluation such as patient selection, surgical success, complications, etc. Surgeon experience and bias and other factors such as lack of uniform standards for evaluation33 also affect the comparison. However, a facility has to be able to provide both ERCP/ EST and LCBDE with experts available in both to conduct a randomized controlled trial. LCBDE is not readily available at every institution, nor is it routinely taught in the surgical residency or even in an advanced laparoscopic fellowship. However, the reason that ERCP is used more frequently for treating choledocholithiasis is that LCBDE is a more highly and technically demanding operation that should not be undertaken by untrained surgeons, whereas most gastroenterologists trained in ERCP are able to perform stone extraction and sphincterotomy routinely. We do not suggest that the average surgeon when confronted with choledocholithiasis should perform LCBDE rather than ERCP/EST. The average surgeon does not have the technical skills to perform the operation safely. So, the articles we used in this meta-analysis have a strong institutional bias for that reason. Disclosure Statement
No competing financial interests exist. References
1. Christoforidis E, Vasiliadis K, Goulimaris I, et al. A single center experience in minimally invasive treatment of postcholecystectomy bile leak, complicated with biloma formation. J Surg Res 2007;141:171–175. 2. Heo JH, Kang DH, Jung HJ, et al. Endoscopic sphincterotomy plus large-balloon dilation versus endoscopic sphincterotomy for removal of bile-duct stones. Gastrointest Endosc 2007;66:720–726. 3. Pi Y, Chen DJ, Chen ZD, et al. The clinical research of laparoscopic choledochotomy vs endoscopic sphincterotomy combined with laparoscopic cholecystectomy in the treatment of common bile duct stones [in Chinese]. Linchuang Waike Zazhi 2008;16:392–394. 4. Chen CZ, Chen CL, Zeng Y. Clinical research on LCCBDE and EST combined LC treatment on small diameter gallstone and common bile duct stones [in Chinese]. Qiqihaer Yixueyuan Xuebao 2009;30:1285–1286. 5. Dai GQ, Hu H. Clinical research of gallbladder and common bile duct stones treated by LC and LCBDE [in Chinese]. Zhongguo Putongwaike Zazhi 2010;19: 843–845. 6. Li YH. Laparoscopic cholecystectomy combined treatment of gallbladder stone with different methods of common bile duct stones [in Chinese]. Henan Waikexue Zazhi 2010; 16:7–9. 7. Liao LK. Minimally invasive treatment of cholecystolithiasis with choledocholithiasis in controlled clinical study. Zhongguo Yiyao Zhinan 2010;8:60–61. 8. Rhodes M, Sussman L, Cohen L, et al. Randomised trial of laparoscopic exploration of common bile duct versus postoperative endoscopic retrograde cholangiography for common bile duct stones. Lancet 1998;351:159–161.
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9. Nathanson LK, O’Rourke NA, Martin IJ, et al. Postoperative ERCP versus laparoscopic choledochotomy for clearance of selected bile duct calculi: A randomized trial. Ann Surg 2005,242:188–192. 10. Cuschieri A, Lezoche E, Morino M, et al. E.A.E.S. multicenter prospective randomized trial comparing twostage vs single-stage management of patients with gallstone disease and ductal calculi. Surg Endosc 1999;13:952–957. 11. Rogers SJ, Cello JP, Horn JK, et al. Prospective randomized trial of LC + LCBDE vs. ERCP/S + LC for common bile duct stone disease. Arch Surg 2010;45:28–33. 12. Noble H, Tranter S, Chesworth T, et al. A randomized, clinical trial to compare endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy with primary laparoscopic bile duct exploration during cholecystectomy in higher risk patients with choledocholithiasis. J Laparoendosc Adv Surg Tech A 2009;19:713–720. 13. Sgourakis G, Karaliotas K. Laparoscopic common bile duct exploration and cholecystectomy versus endoscopic stone extraction and laparoscopic cholecystectomy for choledocholithiasis. A prospective randomized study. Minerva Chir 2002;57:467–474. 14. Bansal VK, Misra MC, Garg P, et al. A prospective randomized trial comparing two-stage versus single-stage management of patients with gallstone disease and common bile duct stones. Surg Endosc 2010;24:1986–1989. 15. Li FL. Comparison of two treatments on cholelithiasis with common bile duct stone: 82 cases [in Chinese]. Zhongguo Putong Waike Zazhi 2012;8:1019–1020. 16. Shen HJ, Chen GY. Clinical analysis of the therapeutic effect of cholelithiasis and common bile duct by three kind of surgical methods [in Chinese]. Gandanyi Waike Zazhi 2012;1(24):33–35. 17. ElGeidie AA, ElShobary MM, Naeem YM. Laparoscopic exploration versus intraoperative endoscopic sphincterotomy for common bile duct stones: A prospective randomized trial. Dig Surg 2011;28:424–431. 18. Heili MJ, Wintz NK, Fowler DL. Choledocholithiasis: Endoscopic versus laparoscopic management. Am Surg 1999; 65:135–138. 19. Freitas ML, Bell RL, Duffy AJ. Choledocholithiasis: Evolving standards for diagnosis and management. World J Gastroenterol 2006;12:3162–31677. 20. Tranter SE, Thompson MH. Comparison of endoscopic sphincterotomy and laparoscopic exploration of the common bile duct. Br J Surg 2002;89:1495–1504. 21. Ong TZ, Khor JL, Selamat DS, et al. Complications of endoscopic retrograde cholangiography in the post-MRCP era: A tertiary center experience. World J Gastroenterol 2005;11:5209–5212. 22. Rhodes M, Sussman L, Cohen L, et al. Randomised trial of laparoscopic exploration of common bile duct versus postoperative endoscopic retrograde cholangiography for common bile duct stones. Lancet 1998;351:159–161. 23. Memon MA, Hassaballa H, Memon MI. Laparoscopic common bile duct exploration: The past, the present, and the future. Am J Surg 2000;179:309–315. 24. Riciardi R, Islam S, Canete JJ, et al. Effectiveness and long-term results of laparoscopic common bile duct exploration. Surg Endosc 2003;17:19–22. 25. Petelin JB. Laparoscopic common bile duct exploration. Surg Endosc 2003;17:1705–1715. 26. Roush TS, Traverso LW. Management and long-term follow-up of patients with positive cholangiograms
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during laparoscopic cholecystectomy. Am J Surg 1995; 169:484–487. Bonnard A, Seguier-Lipszyc E, Liguory C, et al. Laparoscopic approach as primary treatment of common bile duct stones in children. J Pediatr Surg 2005;40: 1459–1463. Suc B, Escat J, Cherqui D, et al. Surgery vs endoscopy as primary treatment in symptomatic patients with suspected common bile duct stones: A multicenter randomized trial. French Associations for Surgical Research. Arch Surg 1998;133:702–708. Freeman ML, Nelson DB, Sherman S, et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996; 335:909–918. Loperfido S, Angelini G, Benedetti G, et al. Major early complications from diagnostic and therapeutic ERCP: A prospective multicenter study. Gastrointest Endosc 1998; 48:1–10. Rojas-Ortega S, Arizpe-Bravo D, Marı´n Lo´pez ER, et al. Transcystic common bile duct exploration in the manage-
ment of patients with choledocholithiasis. J Gastrointest Surg 2003;7:492–496. 32. Thompson MH, Tranter SE. All-comers policy for laparoscopic exploration of the common bile duct. Br J Surg 2002;89:1608–1612. 33. Cohen S, Bacon BR, Berlin JA, et al. National Institutes of Health State-of-the-Science conference statement: ERCP for diagnosis and therapy, January 14–16, 2002. Gastrointest Endosc 2002;56:803–809.
Address correspondence to: Zhi Du, MD, PhD Key Laboratory of Artificial Cells Third Central Hospital Jintang Road No. 83 Tianjin 300170 China E-mail: [email protected]
Full Reports
Laparoscopic Versus Endoscopic Management of Choledocholithiasis in Patients Undergoing Laparoscopic Cholecystectomy: A Meta-analysis Jun-guo Liu, MS,1 Yi-jun Wang, MS,1 Gui-ming Shu, PhD,1 Cheng Lou, PhD,1 Jinjuan Zhang, PhD,1 and Zhi Du, MD, PhD1,2
Abstract
Aim: To compare the clinical effectiveness of the treatment of choledocholithiasis by laparoscopic common bile duct (CBD) exploration and by endoscopic sphincterotomy (EST). Materials and Methods: A meta-analysis of studies about CBD stones was performed to analyze EST in comparison with laparoscopic CBD exploration procedures. Trials were identified by searching the Medline, EMBASE, PubMed, CBM, and CNKI databases from January 1990 to December 2012 for laparoscopic CBD exploration or EST for CBD stones. Results: Fifteen studies were identified in the meta-analysis. The incidence of bleeding or pancreatitis in the EST group was higher than that in the laparoscopic group. However, the incidence of bile leakage in the EST group was lower than that in the laparoscopic group. The differences in cases of retained stones or total complications were not statistically significant between the laparoscopic and EST groups (P > .05). There were more successful cases in the laparoscopic group than in the EST group (P < .05). Hospital cost was less in the laparoscopic group than in the EST group (P < .05). Mean operation time and hospital stay in the laparoscopic group were shorter than those in the EST group (P < .05). Conclusions: To some degree, laparoscopic treatment of the CBD may be a better way of removing stones than EST.
Introduction
C
ommon bile duct (CBD) stones are a common surgical disease. Traditional surgery, with a higher complication rate, is gradually being replaced by minimally invasive surgery. Minimally invasive surgery, which is a new user-friendly advanced surgical method, can effectively reduce or avoid surgical trauma and iatrogenic complications to the patient. Endoscopic sphincterotomy (EST) and laparoscopic CBD exploration (LCBDE), which are both minimally invasive treatments of CBD stones, are two main surgical procedures except for open surgery.1 Laparoscopic exploration of the CBD is becoming more popular, although EST remains the usual treatment for bile duct stones. However, loss of the biliary sphincter causes permanent duodenobiliary reflux, and recurrent stone disease and biliary neoplasia may be a consequence.2 In this article, we search the clinical literature on the application of laparoscopic and endoscopic treatment of CBD 1
stones, in China and abroad, and conduct systematic reviews. Using the evidence-based medicine method, 15 researched article in the clinical literature were examined in a metaanalysis in order to provide a more reasonable clinical basis for the clinical treatment options. Materials and Methods Search strategy and identification of studies
A literature search was performed in the following electronic databases (from January 1990 to December 2012): Medline, EMBASE, PubMed, CBM, and CNKI. The free-text search terms ‘‘common bile duct stone,’’ ‘‘endoscopic sphincterotomy (EST),’’ ‘‘laparoscopic,’’ and ‘‘complication’’ were used. Additionally, the citation lists of all relevant publications, review articles, and included studies were hand-searched. Language limitations in English and Chinese were applied.
Department of Surgery and 2Key Laboratory of Artificial Cells, Tianjin Third Central Hospital, Tianjin, China.
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In the case of overlap between two reports, only the most detailed report was included. Reports about treatments obtained with noncommercial electrodes and treatments with palliative intent (intentional partial debulking) were excluded. When appropriate, authors were contacted to obtain more details about the cases they reported. Data extraction and quality assessment
Data were extracted by three independent observers using standardized forms. The recorded data included the number of patients and complications.The quality of all selected articles was ranked in accordance with the score according to the randomized controlled clinical trial quality evaluation standard (Table 1). Study selection criteria
Inclusion criteria for this analysis were as follows: 1. All selected patients with CBD stones (with or without gallstones) 2. Studies about cases of retained stones, cases of successful clearance of stones, mean operation time, hospital stay, hospital cost, and complications (pancreatitis, bleeding, bile leakage and intestinal perforation, stone recurrence, duodenal papillary stenosis, stenosis of bile duct, reflux cholangitis) 3. Randomized controlled study with years of research carried out or published 4. Clear definition on the sample size, such as number of cases in the EST group and in the laparoscopic group 5. Specific details of the outcome parameters such as cases of retained stones, cases of successful clearance of stones, mean operation time, hospital stay, hospital cost, and complications 6. Based on laparoscopic surgical techniques (choledochoscope exploration, laparoscopic choledocholithotomy, and T-tube drainage) and EST-based surgical procedures 7. Randomized controlled study
Statistical analysis
The dichotomous data results for some of the studies eligible for meta-analysis were expressed as an odds ratio (OR) with 95% confidence intervals (CIs). These results were combined for meta-analysis using the Mantel–Haenszel model, when using the fixed-effects method, and the Der Simonian and Laird method, when using the random-effects method. When the outcome of interest was of continuous data, the differences were pooled across the studies, which provided information on this outcome parameter, resulting in a weighted mean difference (WMD) with 95% CI. The inverse variance method and the DerSimonian and Laird method were used when the fixed- or random-effects method, respectively, was applied. All results were combined for meta-analysis with Review Manager software (2003, Version 4.2 for Windows; The Nordic Cochrane Centre [Copenhagen, Denmark] and The Cochrane Collaboration [London, United Kingdom]). Studyto-study variation was assessed by using the chi-squared statistic (the hypothesis tested was that the studies are all drawn from the same population [i.e., from a population with the same effect size]). A fixed-effects model was used where no heterogeneity was present, whereas in the presence of significant heterogeneity, a random-effects model was applied. A funnel plot analysis and Egger’s test were performed in order to detect the presence of publication bias. Statistical significance was set at a P level of .05. Results Description of trials included in the meta-analysis
According to exclusion and selected criteria of historical data, 15 articles,3–17 including 7 articles3–7,15,16 from Chinese journals, were selected for meta-analysis, including 708 cases in the laparoscopic group and 702 patients in the EST group. The characteristics of the 15 clinical trials included are shown in Table 1. The total incidences of bile leakage in the EST and laparoscopic groups from eight
Table 1. Methodological Quality of Studies Included in the Meta-analysis Reference
Year
Country
Pi et al.3 Chen et al.4 Dai et al.5 Li6 Liao7 Rhodes et al.8 Nathanson et al.9 Cuschieri et al.10 Rogers et al.11 Noble et al.12 Sgourakis and Karaliotas13 Bansal et al.14 Li15 Shen and Chen16 EIGeidie et al.17
2008 2010 2010 2010 2010 1998 2005 1999 2010 2009 2002 2010 2012 2012 2011
China China China China China United Kingdom Australia United Kingdom United States United Kingdom Greece India China China Egypt
Quality evaluation scorea
Study design Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized Randomized
controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled controlled
trial trial trial trial trial trial trial trial trial trial trial trial trial trial trial
3 3 3 3 3 5 5 5 5 5 4 5 3 3 4
a According to the quality of randomized controlled clinical trial evaluation criteria ( Jadad rating scale), a score of q3 indicates highquality research.
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studies4–6,8–10,14,15 are, respectively, 0.5% (2 of 439) and 6.3% (28 of 445). Thus, total incidence of bile leakage in the EST group is lower. From six studies,3,8–11,14 the total incidence of bleeding in EST group was 3.7% (8 of 215), but there was none in the laparoscopic group. The total incidences of pancreatitis in the EST and laparoscopic groups from seven studies3–6,12,14,15 are, respectively, 3.6% (12 of 329) and 0.3% (1 of 348). Thus, the incidence of pancreatitis in the EST group is higher. Meta-analysis
Regarding successful cases of treatment, retained stone, total complication, mean operation time, hospital stay, and hospital cost, the laparoscopic group was compared with the EST group in the treatment of CBD stones by meta-analysis (Fig. 1). Successful cases (meaning the operation of each group was performed successfully). There were 13 trials. The chi-
squared test of heterogeneity was not significant (P = .31). Accordingly, a fixed-effect model was used. There was a difference in successful cases between the laparoscopic group (92.7%) and the EST group (89.1%) with a combined OR of 1.55 (95% CI, 1.04, 2.29; P = .03) (Fig. 1A). There were more successful cases in the laparoscopic group than in the EST group (P < .05). Cases of retained stones. There were 13 trials. The chisquared test of heterogeneity was not significant (P = .58). Accordingly, a fixed-effect model was used. There was no difference in the cases of retained stones between the laparoscopic group (5.1%) and the EST group (6%) with a combined OR of 0.87 (95% CI, 0.54, 1.39; P = .58) (Fig. 1B). Total complications. There were 15 trials. The chisquared test of heterogeneity was significant (P = .05). Accordingly, a random-effect model was used. There was no difference in the total complication rate between the laparoscopic group (15.4%) and the EST group (18.8%) with a combined OR of 0.88 (95% CI, 0.64, 1.2; P = .58) (Fig. 1C). Mean operation time (minutes). There were six trials. The chi-squared test of heterogeneity was not significant (P < .05). Accordingly, a random-effect model was used. Mean operation time in the laparoscopic group was shorter than that in the EST group (P < .05) with a WMD of - 61.84 (95% CI, - 114.42, - 9.26; P = .02) (Fig. 1D). Hospital stay (days). There were 12 trials. The chisquared test of heterogeneity was not significant (P < .05). Accordingly, a random-effect model was used. Hospital stay in the laparoscopic group was less than that in the EST group (P < .05) with a WMD of - 3.32 (95% CI, - 5.69, - 0.95; P < .05) (Fig. 1E). Hospital cost (10,000 yuan). There were only four trials from China. The chi-squared test of heterogeneity was not significant (P < .05). Accordingly, a random-effect model was used. Hospital cost in the laparoscopic group was less than that in the EST group (P < .05) with a WMD of - 0.55 (95% CI, - 0.97, - 0.13; P < .05) (Fig. 1F).
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Sensitivity analysis and publication bias
Publication bias may exist when no significant findings remain unpublished, thus artificially inflating the apparent magnitude of an effect. The outcome parameters from cases of retained stones, total complication, hospital stay, mean operation time, and hospital cost were calculated by the fixed-effect model or random-effect model, respectively. The results were similar, and the combined results were highly reliable. However, the result of successful cases was not similar and not reliable. Funnel plots of the study results are shown in Figure 2. The funnel plots for successful cases, cases of retained stones, total complication, hospital stay, and hospital cost following laparoscopic or EST treatment showed basic symmetry, which suggested no publication bias. However, the funnel plots on mean operation time showed publication bias. Discussion
Ludwig Courvoisier performed the first laparotomy for CBD surgery in Switzerland in 1889. Kawai in Japan and Classen and Demling in Germany first reported the first stone extraction through EST in 1974.18 With the continuous development of endoscopic techniques and instruments, traditional surgical concepts and technology have undergone tremendous change, and the concept of minimally invasive surgery is being developed and established. CBD stone extraction by duodenoscopy has become the primary method of treatment of CBD stones and has been recognized as the preferred method for most scholars. Endoscopic stone extraction is an ideal way to deal with residual bile duct stones and avoids re-operation. Other procedures for CBD stone extraction include percutaneous, transhepatic, and intraoperative CBD exploration, whether laparoscopic or open. The availability of equipment and skilled practitioners who are facile with these techniques varies among institutions. The timing of the intervention is often dictated by the clinical situation.19 Therefore, laparotomy CBD exploration is regarded as the last choice when endoscopic or laparoscopic treatment methods failed. Endoscopic surgery has more advantages than traditional surgery—no abdominal incision, the bile duct incision, less pain, faster recovery, walking after surgery immediately, and eating the same day—so it has become a rapidly popular surgical procedure and is widely applied. It should be noted that the Oddi sphincter is the important valve controlling bile and pancreatic juice discharge, and anatomic or functional abnormalities may lead to dysfunction. EST permanently damages Oddi sphincter function, with counterflow of intestinal contents and pancreatic juice into the biliary tract, and it may cause various chemical and bacterial inflammations, resulting in cholangitis.1 Recurrent biliary tract infection is an important pathogenic and precipitating factor in the process of stone formation. EST postoperative complications, such as serious potential bleeding, perforation, and pancreatitis, began to be of concern. From 1% to 3% of the complications required laparotomy, and the long-term postoperative complication rate of EST increased with time after surgery.20 The mortality rate from endoscopic retrograde
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FIG. 1. The fixed-effects model of odds ratio (OR) for (A) successful cases and (B) retained stone cases and the randomeffects model of (C) OR for complications and weighted mean difference (WMD) for (D) mean operation time, (E) hospital stay, and (F) hospital cost after treatment for the laparoscopic group versus the endoscopic sphincterotomy (EST) group. CI, confidence interval; SD, standard deviation. cholangiopancreatography (ERCP) is 0.2%–0.5%.21,22 Heili et al.18 reported a long-term postoperative CBD stone recurrence rate of EST of 2%–16%, acute cholangitis of 1%–6%, papillary stenosis of 1%–7%, etc. Therefore, the actual long-term complication rate after EST should be higher than the above values because some cases have not appeared during follow-up yet. Furthermore, CBD epi-
thelial hyperplasia, goblet cell metaplasia, and Helicobacter adenoid tissue formation can be caused by chronic inflammation, which may be the pathological basis of bile duct cancer lesions. We think it should be clarified that in some cases patients with choledocholithiasis have not yet undergone cholecystectomy, and this should be part of the discussion about hospital stay being longer in the ERCP
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FIG. 1.
group. If a patient develops post-ERCP pancreatitis, for example, for which we found there is a higher likelihood of occurrence, his or her hospital stay is going to be longer as cholecystectomy will be delayed. This needs to be addressed if we are going to say one of the advantages of LCBDE is a shorter hospital stay. Laparoscopic biliary surgery is another important new minimally invasive technology. Jacobs, Petelin, Philips, and co-workers reported the experience of carrying out laparoscopic stone extraction in 1991, as recorded by Memon et al.23 The technology has become one of the common surgical methods in the treatment of CBD stones. Because there is no damage to Oddi sphincter function, retaining the integrity of the CBD, fewer complications appear after laparoscopic surgery, and complications of laparoscopic surgery are mild and can often be cured through nonsurgical treatment. Long-term follow-up does not demonstrate a significant risk of CBD stricture or other complications for these procedures.24–26 This technique is also advocated in
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(Continued).
the pediatric population by some practitioners as a way of avoiding an ERCP.27 Meta-analysis of these data has confirmed that the laparoscopic group has some advantages compared with the endoscopic group in successful clearance, mean operation time, hospital stay, and hospital cost. Therefore, we believe that in the treatment of CBD stones, laparoscopic treatment is more effective and more reasonable and should be the first choice for appropriate surgical cases. Although the success rate for stone clearance in isolated ERCP treatment is up to 87%–97%, up to 25% of patients require two or more ERCP treatments.28 This method is associated with morbidity and mortality rates of 5%–11% and 0.7%–1.2%, respectively.29,30 LCBDE was associated with successful stone clearance rates ranging from 85% to 95%, a morbidity rate from 4% to 16%, and a mortality rate of around 0%–2%.31,32 This meta-analysis cannot be stratified further according to other possible confounding factors; therefore, the conclusions
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FIG. 2. Funnel plots for comparison of the laparoscopic group versus the endoscopic sphincterotomy (EST) group: (A) 13 articles in the meta-analysis of successful cases of operation, (B) 13 articles in the meta-analysis of a retained stone, (C) 15 articles in the meta-analysis of complications, (D) 6 articles in the meta-analysis of mean operation time, (E) 12 articles in the meta-analysis of hospital stay, and (F) 4 articles in the meta-analysis of hospital cost. OR, odds ratio; SE, standard error; WMD, weighted mean difference. of this study need more detailed data to be confirmed. In our meta-analysis we only searched the Medline database, PubMed database, China Biological Medicine Database, and Chinese full-text database of academic journals, supplemented by retrospective literature, hand-searching, etc., but only in the English and Chinese languages. The sources of data are narrowed, and the integrity of information is
affected to some degree. Also, there is a reporting bias. But, according to these data and the literature, the laparoscopic group has more obvious advantages than the endoscopic group. At present, laparoscopic treatment of choledocholithiasis has been carried out for a short time, and small numbers of cases are reported. We expect a large sample of randomized controlled trials and reliable methodology to
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determine the accuracy of the details of the results and, at the same time through literature updates, to improve the evaluation. Meanwhile, indicators are lack of uniform standards for evaluation such as patient selection, surgical success, complications, etc. Surgeon experience and bias and other factors such as lack of uniform standards for evaluation33 also affect the comparison. However, a facility has to be able to provide both ERCP/ EST and LCBDE with experts available in both to conduct a randomized controlled trial. LCBDE is not readily available at every institution, nor is it routinely taught in the surgical residency or even in an advanced laparoscopic fellowship. However, the reason that ERCP is used more frequently for treating choledocholithiasis is that LCBDE is a more highly and technically demanding operation that should not be undertaken by untrained surgeons, whereas most gastroenterologists trained in ERCP are able to perform stone extraction and sphincterotomy routinely. We do not suggest that the average surgeon when confronted with choledocholithiasis should perform LCBDE rather than ERCP/EST. The average surgeon does not have the technical skills to perform the operation safely. So, the articles we used in this meta-analysis have a strong institutional bias for that reason. Disclosure Statement
No competing financial interests exist. References
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Address correspondence to: Zhi Du, MD, PhD Key Laboratory of Artificial Cells Third Central Hospital Jintang Road No. 83 Tianjin 300170 China E-mail: [email protected]
