Original Article
Is endoscopic sphincterotomy plus large‑balloon dilation a better option than endoscopic large‑balloon dilation alone in removal of large bile duct stones? A retrospective comparison study Li QL1,*, Gao WD1,2,*, Zhang C1, Zhou PH1, Zhong YS1, Chen WF1, Zhang YQ1, Yao LQ1, Xu MD1 Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, 2Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China
1
*Drs. Quan‑Lin Li and Wei‑Dong Gao contributed equally to this work
Correspondence to: Prof. Mei‑Dong Xu, E‑mail: [email protected]
Abstract
BACKGROUND: Several comparison studies have demonstrated that endoscopic sphincterotomy (EST) combined with large‑balloon dilation (LBD)
may be a better option than EST alone to manage large bile duct stones. However, limited data were available to compare this combination method with LBD alone in removal of large bile duct stones. OBJECTIVE: To compare EST plus LBD and LBD alone for the management of large bile duct stones, and analyze the outcomes of each method. PATIENTS AND METHODS: Sixty‑one patients were included in the EST plus LBD group, and 48 patients were included in the LBD alone group retrospectively. The therapeutic success, clinical characteristics, procedure‑related parameters and adverse events were compared. RESULTS: Compared with EST plus LBD, LBD alone was more frequently performed in patients with potential bleeding diathesis or anatomical changes (P = 0.021). The procedure time from successful cannulating to complete stone removal was shorter in the LBD alone group significantly (21.5 vs. 17.3 min, P = 0.041). The EST plus LBD group and the LBD alone group had similar outcomes in terms of overall complete stone removal (90.2% vs. 91.7%, P = 1.000) and complete stone removal without the need for mechanical lithotripsy (78.7% vs. 83.3%, P = 0.542). Massive bleeding occurred in one patient of the EST plus LBD group, and successfully coagulated. Postoperative pancreatitis did not differ significantly between the EST plus LBD group and the LBD alone group (4.9% vs. 6.3%; P = 1.000). CONCLUSION: Endoscopic sphincterotomy combined with LBD offers no significant advantage over LBD alone for the removal of large bile duct stones. LBD can simplify the procedure compared with EST plus LBD in terms of shorten the procedure time. Key Words: Endoscopic large-balloon dilation, endoscopic sphincterotomy, large bile duct stones
Introduction Endoscopic sphincterotomy (EST) is widely considered the approach of choice for most cases of common bile duct stones (CBDSs). Although EST is very effective (complete stone removal can be achieved in 85–90% of patients),[1,2] it carries short‑term risks, such as bleeding, pancreatitis, and perforation; and long‑term complications, such as papillary restenosis and ascending cholangitis.[3] Moreover, removal of CBDSs can be challenging in certain situations, such as the periampullary diverticulum, gastric bypass surgery, stones above strictures, large stones, and impacted stones.[4] Alternatively, endoscopic papillary balloon dilatation (EPBD) has been proposed for this indication because it is thought to preserve the function of the sphincter of Oddi and lessen the complications seen with EST, such as hemorrhage and perforation.[5,6] It is difficult to retrieve large CBDSs using conventional methods, such as EST and EPBD, because of the limited extent of orifice dilation. Recently, a larger opening of the orifice by large balloon dilation (LBD) has been used for papillary dilation for treatment of patients with large CBDS that could not be extracted by EST or EPBD.[7,8] Since then, a number of comparison studies have also suggested that EST combined with LBD can be a better option than EST alone, facilitating large stone extraction and reducing dependence on mechanical lithotripsy (ML), contributing to higher stone clearance in a single endoscopic session with an acceptable risk of complications. [9‑12] However, limited data were available to compare this combination Access this article online Quick Response Code:
Website: www.indianjcancer.com DOI: 10.4103/0019-509X.152000
Indian Journal of Cancer | Volume 51 | Special Issue 1-2014
method with LBD alone in removal of large CBDSs. Herein, we conducted a retrospective research to compare the therapeutic benefits and complications between EST plus LBD and LBD alone for treatment of large CBDSs. Patients and Methods Study design
This retrospective analysis was approved by the local research ethics committee. The analysis included consecutive patients who had large CBDSs and were treated with EST plus LBD or LBD alone by a single operator (Xu MD) at the authors’ institutions between February 2008 and November 2014. Patients were eligible for enrollment in the study if they had visualized bile duct stones ≥12 mm in maximum transverse diameter. In the current study, we defined LBD as the use of a balloon catheter with a diameter larger than 12 mm. Exclusion criteria were bleeding diathesis, prior EST or EPBD, acute pancreatitis, choledochoduodenal fistula, concurrent hepatolithiasis, or concomitant pancreatic or biliary malignancies. Written informed consent was obtained from all patients for the endoscopic procedures. Outcomes measurements
The main outcome measures that compared between two groups were (1) the therapeutic success, complete removal of all CBDSs with or without ML. (2) clinical characteristics and procedure‑related parameters such as number and size of bile duct stones, diameter of inflated balloon, and procedure time from successful CBD cannulating to complete stone removal. (3) procedure‑related adverse events such as massive bleeding, perforation, and postoperative pancreatitis. Procedures
An expert endoscopist (Xu MD) performed endoscopic retrograde cholangiopancreatography (ERCP) using a standard duodenoscope (TJF‑240 or TJF‑260; Olympus Optical Co., Ltd., Tokyo, Japan). Each patient was sedated with a standard dose of diazepam, anisodamine, and meperidine. After the CBD was selectively cannulated using e13
Li, et al.: Endoscopic large-balloon dilation for large bile duct stones
a sphincterotome, an initial cholangiogram was taken. The bile duct and stone diameters were measured during ERCP and corrected for magnification with the external diameter of the distal end of the duodenoscope (12 mm) as a reference. In the EST plus LBD group, EST was performed before LBD from the orifice of the papilla proximally to the transverse fold (minor EST). Wire‑guided hydrostatic balloon catheters (Boston Scientific Microvasive, Cork, Ireland) that can be dilated to the three distinct diameters listed on the package and hub labels were positioned across the major papilla with the balloon mid‑portions placed at the biliary sphincter. The balloon was then gradually inflated to the pressure corresponding to the smallest balloon diameter with dilute contrast medium until the waist of the balloon had disappeared under fluoroscopic guidance. Thereafter, the pressure for inflation of the balloon was gradually increased until the desired dilation was achieved. Once the dilation to the desired diameter was achieved, the balloon was maintained in position for 60 s and then deflated and removed. The balloon diameters used were 12–18 mm, and the diameter of the balloon was selected according to the sizes of the stones and bile duct proximal to the tapered segment under fluoroscopic guidance. The bile duct stones were removed with a basket or retrieval balloon. A mechanical lithotripter was used to fragment the stones when stone extraction could not be achieved using a basket or retrieval balloon, even after LBD. An example of the LBD alone procedure is presented in Figures 1 and 2. Postprocedure evaluation
Serum amylase, total bilirubin, and alkaline phosphatase levels; complete blood counts; and abdominal radiographs were checked before procedures and on the following day to monitor for complications such as bleeding, perforation, acute pancreatitis, and acute cholangitis. Post‑ERCP pancreatitis was defined as persistent epigastric pain of >24 h with a ≥3‑fold elevation in serum amylase according to 1991 consensus guidelines.[13] Statistical analysis
Statistical analysis was performed with SPSS 17.0 software (SPSS, Chicago, IL, USA). Statistical significance
a
c
Results Clinical characteristics
After thoroughly investigating the database and their medical records, 61 patients were included in the EST plus LBD group, and 48 patients were included in the LBD alone group. Table 1 summarizes the clinical characteristics of those patients. There were no significant differences between the two groups with regard to age, size and number of stones, or maximum bile duct diameter. In the LBD alone group, two patients underwent prior liver transplantation, one patient underwent a prior Billroth II gastrectomy, one patient underwent a prior biliary‑enteric anastomosis, and three patients had liver cirrhosis and esophageal varices. While in the EST plus LBD group, only one patient had liver cirrhosis and esophageal varices. Overall, compared with EST plus LBD, LBD alone were more frequently performed in patients with potential bleeding diathesis or anatomical changes (P = 0.021). Procedure‑related parameters
Large‑balloon dilation with or without EST was successfully performed in all patients. As shown in Table 2, distal extrahepatic bile duct stenosis was found in one patient of the EST plus LBD group and in three patients of the LBD alone group on initial cholangiogram. The mean diameter of the balloon used for LBD was 15.7 mm (range, 12–18 mm) for the EST plus LBD group and 14.2 mm (range, 12–18 mm) for the LBD alone group (P = 0.376). The mean procedure time from successful CBD cannulating to complete stone removal was significantly shorter in the LBD alone group compared with the EST plus LBD group (21.5 [range, 10–42] vs. 17.3 [8–35] min; P = 0.041). Therapeutic success
Complete duct clearance occurred in 55 patients by EST plus LBD while in 44 patients by LBD alone. The
a
b
c
d
b
d
Figure 1: Endoscopic view of large-balloon dilation alone for the removal of a large common bile duct stone. (a) Selective cannulating the bile duct was achieved. (b) Large balloon inflated across the papilla. (c) Postdilated papilla. (d) The bile duct stone was removed with a basket
e14
was evaluated using Student’s t‑test, Chi‑square test, or Fisher’s exact test as appropriate. All reported P values were two‑tailed, and P
Is endoscopic sphincterotomy plus large‑balloon dilation a better option than endoscopic large‑balloon dilation alone in removal of large bile duct stones? A retrospective comparison study Li QL1,*, Gao WD1,2,*, Zhang C1, Zhou PH1, Zhong YS1, Chen WF1, Zhang YQ1, Yao LQ1, Xu MD1 Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, 2Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China
1
*Drs. Quan‑Lin Li and Wei‑Dong Gao contributed equally to this work
Correspondence to: Prof. Mei‑Dong Xu, E‑mail: [email protected]
Abstract
BACKGROUND: Several comparison studies have demonstrated that endoscopic sphincterotomy (EST) combined with large‑balloon dilation (LBD)
may be a better option than EST alone to manage large bile duct stones. However, limited data were available to compare this combination method with LBD alone in removal of large bile duct stones. OBJECTIVE: To compare EST plus LBD and LBD alone for the management of large bile duct stones, and analyze the outcomes of each method. PATIENTS AND METHODS: Sixty‑one patients were included in the EST plus LBD group, and 48 patients were included in the LBD alone group retrospectively. The therapeutic success, clinical characteristics, procedure‑related parameters and adverse events were compared. RESULTS: Compared with EST plus LBD, LBD alone was more frequently performed in patients with potential bleeding diathesis or anatomical changes (P = 0.021). The procedure time from successful cannulating to complete stone removal was shorter in the LBD alone group significantly (21.5 vs. 17.3 min, P = 0.041). The EST plus LBD group and the LBD alone group had similar outcomes in terms of overall complete stone removal (90.2% vs. 91.7%, P = 1.000) and complete stone removal without the need for mechanical lithotripsy (78.7% vs. 83.3%, P = 0.542). Massive bleeding occurred in one patient of the EST plus LBD group, and successfully coagulated. Postoperative pancreatitis did not differ significantly between the EST plus LBD group and the LBD alone group (4.9% vs. 6.3%; P = 1.000). CONCLUSION: Endoscopic sphincterotomy combined with LBD offers no significant advantage over LBD alone for the removal of large bile duct stones. LBD can simplify the procedure compared with EST plus LBD in terms of shorten the procedure time. Key Words: Endoscopic large-balloon dilation, endoscopic sphincterotomy, large bile duct stones
Introduction Endoscopic sphincterotomy (EST) is widely considered the approach of choice for most cases of common bile duct stones (CBDSs). Although EST is very effective (complete stone removal can be achieved in 85–90% of patients),[1,2] it carries short‑term risks, such as bleeding, pancreatitis, and perforation; and long‑term complications, such as papillary restenosis and ascending cholangitis.[3] Moreover, removal of CBDSs can be challenging in certain situations, such as the periampullary diverticulum, gastric bypass surgery, stones above strictures, large stones, and impacted stones.[4] Alternatively, endoscopic papillary balloon dilatation (EPBD) has been proposed for this indication because it is thought to preserve the function of the sphincter of Oddi and lessen the complications seen with EST, such as hemorrhage and perforation.[5,6] It is difficult to retrieve large CBDSs using conventional methods, such as EST and EPBD, because of the limited extent of orifice dilation. Recently, a larger opening of the orifice by large balloon dilation (LBD) has been used for papillary dilation for treatment of patients with large CBDS that could not be extracted by EST or EPBD.[7,8] Since then, a number of comparison studies have also suggested that EST combined with LBD can be a better option than EST alone, facilitating large stone extraction and reducing dependence on mechanical lithotripsy (ML), contributing to higher stone clearance in a single endoscopic session with an acceptable risk of complications. [9‑12] However, limited data were available to compare this combination Access this article online Quick Response Code:
Website: www.indianjcancer.com DOI: 10.4103/0019-509X.152000
Indian Journal of Cancer | Volume 51 | Special Issue 1-2014
method with LBD alone in removal of large CBDSs. Herein, we conducted a retrospective research to compare the therapeutic benefits and complications between EST plus LBD and LBD alone for treatment of large CBDSs. Patients and Methods Study design
This retrospective analysis was approved by the local research ethics committee. The analysis included consecutive patients who had large CBDSs and were treated with EST plus LBD or LBD alone by a single operator (Xu MD) at the authors’ institutions between February 2008 and November 2014. Patients were eligible for enrollment in the study if they had visualized bile duct stones ≥12 mm in maximum transverse diameter. In the current study, we defined LBD as the use of a balloon catheter with a diameter larger than 12 mm. Exclusion criteria were bleeding diathesis, prior EST or EPBD, acute pancreatitis, choledochoduodenal fistula, concurrent hepatolithiasis, or concomitant pancreatic or biliary malignancies. Written informed consent was obtained from all patients for the endoscopic procedures. Outcomes measurements
The main outcome measures that compared between two groups were (1) the therapeutic success, complete removal of all CBDSs with or without ML. (2) clinical characteristics and procedure‑related parameters such as number and size of bile duct stones, diameter of inflated balloon, and procedure time from successful CBD cannulating to complete stone removal. (3) procedure‑related adverse events such as massive bleeding, perforation, and postoperative pancreatitis. Procedures
An expert endoscopist (Xu MD) performed endoscopic retrograde cholangiopancreatography (ERCP) using a standard duodenoscope (TJF‑240 or TJF‑260; Olympus Optical Co., Ltd., Tokyo, Japan). Each patient was sedated with a standard dose of diazepam, anisodamine, and meperidine. After the CBD was selectively cannulated using e13
Li, et al.: Endoscopic large-balloon dilation for large bile duct stones
a sphincterotome, an initial cholangiogram was taken. The bile duct and stone diameters were measured during ERCP and corrected for magnification with the external diameter of the distal end of the duodenoscope (12 mm) as a reference. In the EST plus LBD group, EST was performed before LBD from the orifice of the papilla proximally to the transverse fold (minor EST). Wire‑guided hydrostatic balloon catheters (Boston Scientific Microvasive, Cork, Ireland) that can be dilated to the three distinct diameters listed on the package and hub labels were positioned across the major papilla with the balloon mid‑portions placed at the biliary sphincter. The balloon was then gradually inflated to the pressure corresponding to the smallest balloon diameter with dilute contrast medium until the waist of the balloon had disappeared under fluoroscopic guidance. Thereafter, the pressure for inflation of the balloon was gradually increased until the desired dilation was achieved. Once the dilation to the desired diameter was achieved, the balloon was maintained in position for 60 s and then deflated and removed. The balloon diameters used were 12–18 mm, and the diameter of the balloon was selected according to the sizes of the stones and bile duct proximal to the tapered segment under fluoroscopic guidance. The bile duct stones were removed with a basket or retrieval balloon. A mechanical lithotripter was used to fragment the stones when stone extraction could not be achieved using a basket or retrieval balloon, even after LBD. An example of the LBD alone procedure is presented in Figures 1 and 2. Postprocedure evaluation
Serum amylase, total bilirubin, and alkaline phosphatase levels; complete blood counts; and abdominal radiographs were checked before procedures and on the following day to monitor for complications such as bleeding, perforation, acute pancreatitis, and acute cholangitis. Post‑ERCP pancreatitis was defined as persistent epigastric pain of >24 h with a ≥3‑fold elevation in serum amylase according to 1991 consensus guidelines.[13] Statistical analysis
Statistical analysis was performed with SPSS 17.0 software (SPSS, Chicago, IL, USA). Statistical significance
a
c
Results Clinical characteristics
After thoroughly investigating the database and their medical records, 61 patients were included in the EST plus LBD group, and 48 patients were included in the LBD alone group. Table 1 summarizes the clinical characteristics of those patients. There were no significant differences between the two groups with regard to age, size and number of stones, or maximum bile duct diameter. In the LBD alone group, two patients underwent prior liver transplantation, one patient underwent a prior Billroth II gastrectomy, one patient underwent a prior biliary‑enteric anastomosis, and three patients had liver cirrhosis and esophageal varices. While in the EST plus LBD group, only one patient had liver cirrhosis and esophageal varices. Overall, compared with EST plus LBD, LBD alone were more frequently performed in patients with potential bleeding diathesis or anatomical changes (P = 0.021). Procedure‑related parameters
Large‑balloon dilation with or without EST was successfully performed in all patients. As shown in Table 2, distal extrahepatic bile duct stenosis was found in one patient of the EST plus LBD group and in three patients of the LBD alone group on initial cholangiogram. The mean diameter of the balloon used for LBD was 15.7 mm (range, 12–18 mm) for the EST plus LBD group and 14.2 mm (range, 12–18 mm) for the LBD alone group (P = 0.376). The mean procedure time from successful CBD cannulating to complete stone removal was significantly shorter in the LBD alone group compared with the EST plus LBD group (21.5 [range, 10–42] vs. 17.3 [8–35] min; P = 0.041). Therapeutic success
Complete duct clearance occurred in 55 patients by EST plus LBD while in 44 patients by LBD alone. The
a
b
c
d
b
d
Figure 1: Endoscopic view of large-balloon dilation alone for the removal of a large common bile duct stone. (a) Selective cannulating the bile duct was achieved. (b) Large balloon inflated across the papilla. (c) Postdilated papilla. (d) The bile duct stone was removed with a basket
e14
was evaluated using Student’s t‑test, Chi‑square test, or Fisher’s exact test as appropriate. All reported P values were two‑tailed, and P
