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ORIGINAL ARTICLE
Year : 2014  |  Volume : 51  |  Issue : 6  |  Page : 13-17
 

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


1 Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China
2 Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University; Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China

Date of Web Publication24-Feb-2015

Correspondence Address:
M D Xu
Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai
China
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Source of Support: This study was supported by the grants from the Major Project of Shanghai Municipal Science and Technology Committee (14441901500), National Natural Science Foundation of China (81302098, 81370588 and 81201902), and Natural Science Foundation of Shanghai (13ZR1452300), Conflict of Interest: None


DOI: 10.4103/0019-509X.152000

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 » 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.


Keywords: Endoscopic large-balloon dilation, endoscopic sphincterotomy, large bile duct stones


How to cite this article:
Li Q L, Gao W D, Zhang C, Zhou P H, Zhong Y S, Chen W F, Zhang y Q, Yao L Q, Xu M D. 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. Indian J Cancer 2014;51, Suppl S2:13-7

How to cite this URL:
Li Q L, Gao W D, Zhang C, Zhou P H, Zhong Y S, Chen W F, Zhang y Q, Yao L Q, Xu M D. 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. Indian J Cancer [serial online] 2014 [cited 2021 Oct 21];51, Suppl S2:13-7. Available from: https://www.indianjcancer.com/text.asp?2014/51/6/13/152000

FNx01Drs. Quan Lin Li and Wei Dong Gao contributed equally to this work



 » Introduction Top


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 More Details 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],[10],[11],[12] However, limited data were available to compare this combination 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 Top


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 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 [Figure 1] and [Figure 2].
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

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Figure 2: Fluoroscopic view of large - balloon dilation alone for the removal of a large common bile duct stone. (a) Cholangiogram demonstrating a large bile duct stone (maximum transverse diameter, 13.5 mm). (b) Large balloon gradually inflated across over guidewire within the bile duct that contained the stone. (c) Large balloon inflated until the waist of the balloon had disappeared. (d) The bile duct stone was removed with a basket

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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 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 < 0.05 was considered to indicate statistical significance.


 » Results Top


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).
Table 1: Clinical characteristics of the patients

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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).
Table 2: Comparison of stone retrieval and procedure-related adverse events between groups

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Therapeutic success

Complete duct clearance occurred in 55 patients by EST plus LBD while in 44 patients by LBD alone. The therapeutic success was ultimately similar between two groups, irrespective of whether ML was used (EST plus LBD group vs. LBD alone group; 90.2% vs. 91.7%; P = 1.000). The stones were completely removed in the first session without using ML in 48 (78.7%) patients of the EST plus LBD group and in 40 (83.3%) patients of the LBD alone group (P = 0.542). Thereafter, ML was attempted in other patients without complete stone clearance during the first session (EST plus LBD group vs. LBD alone group; 8 [13.1%] vs. 7 [14.6%]; P = 0.825). Despite the fact that ML was applied, complete stone clearance was still failed in one patient of the EST plus LBD group and in three patients of the LBD alone group. The causes of failure were stone impaction and incomplete stone capture with the basket. These patients then underwent surgery to remove the stones.

Adverse events

As shown in [Table 2], massive bleeding occurred in one patient of the EST plus LBD group and successfully coagulated with a hemostatic forceps. Postoperative pancreatitis did not differ significantly between the two groups (EST plus LBD group vs. LBD alone group; 3 [4.9%] vs. 3 [6.3%]; P = 1.000), and these cases were mild and self-limiting. No perforation or postoperative cholangitis occurred in either group.


 » Discussion Top


During ERCP, EST or endoscopic EPBD is the standard method of enlarging the papillary orifice before stone retrieval. EPBD is a safe and effective technique for removal of small to moderate sized stones, but it is inappropriate for removal of larger stones since EPBD does not enlarge the bile duct opening to the same extent as EST. Thus, LBD using balloon diameters of 12-20 mm was introduced for the removal of large CBDSs. [7],[8] However, LBD was not fully accepted for the risk of potentially serious adverse events, such as pancreatitis and bile duct perforation. [9],[10],[11],[12],[14]

Thus, EST has usually been performed before LBD in order to provide the highest success rate with the lowest complication rate. Several study demonstrated that EST plus LBD is a safe and effective alternative to EST alone in the treatment of CBDS. [9],[10],[11],[12],[14] These authors also suggested that EST plus LBD might lower the risk of postprocedure pancreatitis by directing LBD toward the bile duct rather than the pancreatic duct. [9],[10],[11],[12],[14] However, because EST is arbitrary during combination therapy and the procedure is technically demanding when compared with EST or balloon dilation alone, there has been no significant decrease in lithotripsy use, even though the complication rate associated with the combined therapy may be low. Recent studies have shown that LBD without preceding EST is safe and effective in patients with large CBDSs. [15],[16] Till now, limited direct evidence has been available to compare this combination method with LBD alone in removal of large CBDSs. [17],[18]

In the current study, the therapeutic benefits and complications between EST plus LBD and LBD alone were compared for treatment of large CBDSs. We found that the success rate of bile duct clearance after LBD alone was similar to the combination method in terms of overall complete stone removal (90.2% vs. 91.7%, P = 1.000) and complete stone removal without the need for ML (78.7% vs. 83.3%, P = 0.542). The need for ML was also similar was also comparable between two groups (EST plus LBD group vs. LBD alone group; 3.1% vs. 14.6%; P = 0.825).

With respect to short-term complications, acute bleeding occurred in one patient of the EST plus LBD group, and successfully coagulated. No perforation occurred in either group. Although the rates of bleeding and perforation were not significantly different between the two groups, LBD alone should be considered in selected patients with severe coagulopathy, as well as in patients with anatomical changes which may induce a high risk of perforation during EST. In our study, LBD alone was more frequently performed in these patients with potential bleeding diathesis or anatomical changes (P = 0.021).

For most biliary endoscopists, the biggest concern is not bleeding, but severe pancreatitis that leads to surgical intervention or mortality. In our study, postoperative pancreatitis did not differ significantly between the two groups (4.9% vs. 6.3%; P = 1.000). Till now no effective treatment can successful prevent post-ERCP pancreatitis. However, the relative low rate of pancreatitis for both groups can be explained as follows: (1) Selective cannulating the CBD should be attempted during the ERCP. That can avoid cannulating or excessive injection of the pancreatic duct. (2) Similar to EST plus LBD, LBD alone can provide wider papillary access achieved with large balloon inflation and effective biliary drainage, both of which contribute to prevent the obstruction of the ampullary orifice and relieve papillary. A large opening of the bile duct also can prevent accidental cannulation of the pancreatic duct in the subsequent stone extraction and stone impaction in the common channel. (3) The setting of this study was a single, tertiary university medical center with a large volume of ERCPs, and the procedures were performed by an experienced biliary endoscopist. (4) After stone extraction, bile duct drainage using plastic stent were performed in most patients. This method can provide smooth drainage and may contribute to prevent pancreatitis to some extent.

Based on the similar rates of successful stone removal and complications, LBD alone does seem to offer an effective means for large CBDS removal. Moreover, LBD alone may simplify the procedure compared with EST plus LBD in theory. This hypothesis has been confirmed by our comparison study. We found that the procedure time from successful CBD cannulating to complete stone removal was significantly shorter in the LBD alone group than that in the EST plus LBD group (21.5 vs. 17.3 min; P = 0.041).

With respect to long-term complications, recurrent choledocholithiasis after LBD or EST is a main concern. LBD alone can be better treatment of choice for extracting CBDSs since it still preserves the function of sphincter muscle than EST in theory. [5],[6] Theoretically, balloon dilation is likely to reduce chronic contamination of the bile duct from enteric biliary reflux, thus reducing the likelihood of stone formation. Stone recurrence after ERCP should also be addressed considering long-term outcome. [18],[19] Further observations and follow-up are needed to evaluate these long-term outcome and complications.

Naturally, the retrospective analyses have inherent methodological limitations, especially in view of the limited case number, and they need definitive confirmation by larger and prospective studies. The potential selection bias may occur since our hospital is tertiary referral centers. Finally, lack of long-term follow-up period is also a major limitation. [20],[21]


 » Conclusion Top


Our study found that EST combined with LBD offers no significant advantage over LBD alone for the removal of large bile duct stones. Moreover, LBD alone can simplify the procedure compared with EST plus LBD, and provide advantages for selected patients with severe coagulopathy or anatomical changes. Preceding EST may be unnecessary. However, these results should be confirmed in multi-center prospective studies with long-term follow-up.

 
 » References Top

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Bergman JJ, Rauws EA, Fockens P, van Berkel AM, Bossuyt PM, Tijssen JG, et al. Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bileduct stones. Lancet 1997;349:1124-9.  Back to cited text no. 6
    
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Attasaranya S, Cheon YK, Vittal H, Howell DA, Wakelin DE, Cunningham JT, et al. Large-diameter biliary orifice balloon dilation to aid in endoscopic bile duct stone removal: A multicenter series. Gastrointest Endosc 2008;67:1046-52.  Back to cited text no. 8
    
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Heo JH, Kang DH, Jung HJ, Kwon DS, An JK, Kim BS, et al. Endoscopic sphincterotomy plus large-balloon dilation versus endoscopic sphincterotomy for removal of bile-duct stones. Gastrointest Endosc 2007;66:720-6.  Back to cited text no. 9
    
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Misra SP, Dwivedi M. Large-diameter balloon dilation after endoscopic sphincterotomy for removal of difficult bile duct stones. Endoscopy 2008;40:209-13.  Back to cited text no. 10
    
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Itoi T, Itokawa F, Sofuni A, Kurihara T, Tsuchiya T, Ishii K, et al. Endoscopic sphincterotomy combined with large balloon dilation can reduce the procedure time and fluoroscopy time for removal of large bile duct stones. Am J Gastroenterol 2009;104:560-5.  Back to cited text no. 11
    
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Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, et al. Endoscopic sphincterotomy complications and their management: An attempt at consensus. Gastrointest Endosc 1991;37:383-93.  Back to cited text no. 13
    
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Prachayakul V, Aswakul P. Tapered-tip catheter dilatation: a safe technique for EUS-guided transesophageal drainage of peripancreatic fluid collections. J Interv Gastroenterol. 2013;3:31-33.  Back to cited text no. 14
    
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Jeong S, Ki SH, Lee DH, Lee JI, Lee JW, Kwon KS, et al. Endoscopic large-balloon sphincteroplasty without preceding sphincterotomy for the removal of large bile duct stones: A preliminary study. Gastrointest Endosc 2009;70:915-22.  Back to cited text no. 15
    
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Hwang JC, Kim JH, Lim SG, Kim SS, Shin SJ, Lee KM, et al. Endoscopic large-balloon dilation alone versus endoscopic sphincterotomy plus large-balloon dilation for the treatment of large bile duct stones. BMC Gastroenterol 2013;13:15.  Back to cited text no. 17
    
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    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2]

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