Prospective comparative study of endoscopic papillary large balloon dilation and endoscopic sphincterotomy for removal of large bile duct stones in patients above 45 years of age

Abstract

Objective. Although endoscopic papillary large balloon dilation (EPLBD) with limited endoscopic sphincterotomy (ES) showed excellent outcomes for treatment of large bile duct stones, hemorrhage and recurrence of stones are problematic complications. Recent studies suggest that EPLBD alone is safe and effective for removal of large bile duct stones. This study aimed to determine the therapeutic outcomes and safety of EPLBD, compared with ES, for removal of large bile duct stones. Material and methods. Eighty-three patients above 45 years of age with bile duct stones >1 cm in diameter were randomized to EPLBD and ES groups for removal of common bile duct stones from September 2010 to August 2011. Prophylactic gabexate mesilate was given to all patients. Results. Baseline characteristics were not significantly different, except diabetes and gallbladder stones between the EPLBD group (n = 40) and ES group (n = 43). The overall complete stone removal rate in each group was 97.5% (39/40) and 95.3% (41/43), respectively (p = 0.600). Requirement of mechanical lithotripsy was not significantly different between the EPLBD and ES group (10% vs. 21%, p = 0.171). Complete ductal clearance in one session was achieved in 82.4% and 81.4% of cases in each group, respectively (p = 0.577). There were no differences in complication rates between the EPLBD and ES group; pancreatitis, 5.0% vs. 7.0%; hemorrhage, 10.0% vs. 16.3%; acute cholangitis, 5.0% vs. 2.3%, and perforation, 2.5% vs. 0%. Conclusions. The therapeutic outcomes and complications of EPLBD for removal of large bile duct stones are comparable to those of ES.     

Large balloon dilation post endoscopic sphincterotomy in removal of difficult common bile duct stones:A literature review

Endoscopic sphincterotomy(ES)is the standard therapy in common bile duct(CBD)stones extraction.Large stones(≥12 mm)or multiple stones extraction may be challenging after ES alone.Endoscopic sphincterotomy followed by large balloon dilation(ESLBD)has been described as an alternative to ES in these indications.Efficacy,safety,cost-effectiveness and technical aspects of the procedure have been here reviewed.PubMed and Google Scholar search resulted in fortyone articles dealing with CBD stone extraction with12 mm or more dilation balloons after ES.ESLBD is at least as effective as ES,and reduces the need for additional mechanical lithotripsy.Adverse events rates are not statistically different after ESLBD compared to ES for pancreatitis,bleeding and perforation.However,particular attention should be paid in patients with CBD strictures,which is identified as a risk factor of perforation.ESLBD is slightly cost-effective compared to ES.A small sphincterotomy is usually performed,and may reduce bleeding rates compared to full sphincterotomy.Dilation is performed with 12-20 mm enteral balloons.Optimal inflation time is yet to be determined.The procedure can be performed safely even in patients with peri-ampullary diverticula and surgically altered anatomy.ESLBD is effective and safe in the removal of large CBD stones,however,small sphincterotomy might be preferred and CBD strictures should be considered as a relative contraindication.     

Endoscopic papillary large balloon dilation for large common bile duct stones

Endoscopic papillary large balloon dilation (EPLBD) involves endoscopic biliary sphincterotomy (EBS) followed by balloon dilation using a 12–20-mm balloon to remove large or difficult stones from the common bile duct. The complications and limitations of endoscopic biliary sphincterotomy (EBS) are well known. Endoscopic papillary balloon dilation (EPBD) with a smaller diameter balloon but without sphincterotomy is widely used in a number of regions of the world for removal of routine bile duct stones and has been investigated as an alternative to EBS. EPBD, however, appears to be associated with an increased risk of pancreatitis. EPLBD differs from EPBD as it involves EBS followed by large balloon dilation. EPLBD would theoretically combine advantages of sphincterotomy and balloon dilation by increasing efficacy at stone extraction while minimizing complications of both EBS and EBD. A review of the available literature for EPBLD shows that it is relatively safe and effective. A high success rate (up to 95%) has been described for stone removal using EPLBD, with a low complication rate. Unlike EPBD, EBLBD does not appear to be associated with a higher risk of post-ERCP pancreatitis, probably because of separation of the biliary and pancreatic sphincters after EBS. EPLBD appears to be a reasonable option for removal of large or difficult common bile duct stones. This technique may be especially helpful in patients with difficult papillary anatomy, such as those with small papillae, intra- or peri-diverticular papilla. Its role in patients with coagulopathy or other risks for bleeding remains to be investigated.     

十二指肠乳头切开术联合球囊扩张术在肝外胆管结石内镜治疗中的作用

目的 探讨十二指肠乳头切开术(EST)联合十二指肠乳头球囊扩张术(EPBD)在肝外胆管结石内镜治疗中的安全性及其疗效.方法 164例肝外胆管结石患者接受内镜取石治疗,其中78例取石前进行EST联合EPBD治疗(EST+ EPBD组),其余86例取石前进行单一EST治疗(EST组),对比分析2组并发症发生率、结石取净率和碎石发生率.结果 EST+ EPBD组出现高淀粉酶血症3例、轻症急性胰腺炎2例,EST组出现高淀粉酶血症5例、轻症急性胰腺炎3例、出血2例,2组均未出现重症急性胰腺炎、穿孔等严重并发症.EST+ EPBD组并发症发生率为6.4％( 5/78),略低于EST组的11.6％ (10/86)(x2=1.340,P=0.288);结石取净率为100.0％ (78/78),明显高于EST组的93.0％( 80/86)(x2=5.649,P=0.030);碎石发生率为33.3％( 26/78),明显低于EST组的60.5％(52/86)(x2=12.073,P=0.001).结论 EST联合EPBD应用肝外胆管结石内镜治疗中安全、有效,对于结石大、乳头条件差的患者效果尤其明显.     

Recurrence of bile duct stones after endoscopic papillary large balloon dilation combined with limited sphincterotomy: long-term follow-up study

Background/Aims

Endoscopic papillary large-balloon dilation combined with limited endoscopic sphincterotomy (EPLBD+ES) is promising for the treatment of common bile duct (CBD) stones. The aim of this study was to clarify the recurrence rate and the risk factors for CBD stones after EPLBD+ES.

Methods

In total, 100 patients who underwent EPLBD+ES from 2006 to 2007 were evaluated retrospectively. One hundred and nine patients who were treated with endoscopic sphincterotomy (ES) from 2004 to 2005 were set as the historical control group. Various risk factors for the recurrence of bile duct stones were analyzed.

Results

Of the 209 patients, the duration of follow-up was 32.5±4.5 months in the EPLBD+ES group and 31.8±6.0 months in the ES group. The recurrence rate of CBD stones was 11.0% (11/100) in the EPLBD+ES group and 13.8% (15/109) in the ES group (p=0.546). The cumulative recurrence rate of stones was not significantly different between the EPLBD+ES and ES groups (log rank, p=0.537). Univariate analysis showed that the diameter of the CBD (≥22 mm) was the only predictive variable that could differentiate recurrence from nonrecurrence in the EPLBD+ES group. Multivariate analysis revealed that the diameter of the bile duct was the only risk factor for stone recurrence (p=0.022; odds ratio, 1.175; 95% confidence interval, 1.023 to 1.348).

Conclusions

The recurrence rate of CBD stones after EPLBD+ES is comparable to that of the ES group, and a dilated CBD appears to increase the risk of bile duct stone recurrence.     

Efficacy and safety of low-pressured and short-time dilation in endoscopic papillary balloon dilation for bile duct stone removal

Background and Aim:  Endoscopic papillary balloon dilation (EPBD) has been advocated as an alternative therapy to endoscopic sphincterotomy for bile duct stones. However, studies have shown that EPBD may increase the risk for pancreatitis. Pancreatitis after EPBD is believed to be related to papillary damage after balloon dilation. We changed the dilation method to a theoretically less hazardous one. This modified dilation method was compared with the initial method.
Methods:  A total of 324 patients with bile duct stones underwent EPBD by the modified method between June 1999 and June 2003. Three hundred and twenty-four patients undergoing EPBD by the initial method served as a historical control group. The success rate of stone removal and the incidence of procedure-related pancreatitis were compared between the two groups. In the modified method, the balloon was inflated until disappearance of the balloon waist, and the pressure was then maintained for 15 s. In the initial method, the balloon was inflated at 8 atmospheres for 2 min.
Results:  Bile duct stones were successfully removed in 313 of 324 patients (96.6%) in the modified group and in 314 of 324 patients (96.9%) in the initial group (not significant). The incidence of postprocedure pancreatitis showed a lower tendency in the modified group (4.0%, 13/324) than in the initial group (7.4%, 24/324) ( P -value = 0.0626). The severity of pancreatitis was significantly reduced in the modified group.
Conclusion:  The modified method of EPBD is feasible for extraction of bile duct stones, and may potentially decrease the incidence of severe post-EPBD pancreatitis.     

Comparison between endoscopic papillary balloon dilatation and endoscopic sphincterotomy for the treatment of common bile duct stones

Background This study was designed to evaluate the therapeutic outcome and early postoperative complications, especially pancreatitis, of endoscopic papillary balloon dilation (EPBD) and endoscopic sphincterotomy (EST) in patients with common bile duct stones in our department. Methods One hundred eighty patients with common bile duct stones were randomized to undergo EPBD or EST. An 8-mm dilatation balloon was used for EPBD. Modified Cotton's criteria, in which relatively mild pancreatitis is also included as a complication, were used to determine the incidence of postoperative complications. Results The rate of complete removal of stones was significantly higher in the EST group (95.6%) than in the EPBD group (86.6%); for stones less than 10 mm in diameter, however, the rate with EPBD (93.8%) was almost equivalent to that with EST (98.1%). According to modified Cotton's criteria, the incidence of postoperative pancreatitis was significantly higher in the EPBD group (16.7%) than in the EST group (6.7%). Bleeding was encountered in one patient (1.1%) in the EST group, but in none in the EPBD group. No fatal complication occurred in either the EPBD or the EST group. Conclusions Although EPBD appears to be comparable to EST for removal of small common bile duct stones, mild postoperative pancreatitis is more likely to occur with EPBD than with EST.     

十二指肠乳头括约肌小切开联合气囊扩张治疗难治性胆总管结石的疗效评价

目的 探讨乳头括约肌小切开联合气囊扩张治疗难治性胆总管结石的效果和安全性.方法 将2008年3月至2009年12月收治的难治性胆总管结石患者随机分为两组,分别为乳头括约肌切开组及乳头括约肌小切开联合气囊扩张组,比较两组间结石取净率、取石次数、机械碎石使用率、并发症发生率.结果 两组间结石取净率、早期并发症发生率,差异无统计学意义（2/61比2/62,6/61比4/62;P＞0.05）;乳头括约肌切开组需多次及需要使用机械碎石才能取净结石的比例以高于乳头括约肌小切开联合气囊扩张组,率差异有统计学意义（15/61比5/62,12/6l比4/62;P＜0.05）.结论 乳头括约肌小切开联合气囊扩张与乳头括约肌切开两种方法同样安全有效;乳头括约肌小切开联合气囊扩张操作更简便.     

A review of treatment options for bile duct stones

Introduction: Approximately 10–15% of bile duct stones cannot be treated using conventional stone removal techniques. For difficult common bile duct stones (CBDS), various endoscopic techniques have been developed. This review covers technical tips and endoscopic treatments including Endoscopic retrograde cholangiopancreatography (ERCP), particularly under Endoscopic ultrasound (EUS) guidance.

Areas covered: Literatures about endoscopic treatment for bile duct stone were searched in Pub Med. As novel methods, EUS-guided approaches have also been reported, although long-term results and prospective evaluation are not yet sufficient. Large stones may need fragmentation prior to removal, to prevent stone impaction. To perform fragmentation, mechanical lithotripsy, extracorporeal shock wave lithotripsy or laser lithotripsy techniques are available.

Expert commentary: Despite the fact that most bile duct stones can be treated using endoscopic techniques, endoscopists should remind to be able to select the temporary biliary stenting or percutaneous transhepatic cholangiodrainage as an option.     

X线监视下激光碎石治疗难治性胆总管结石的效果研究

目的 探讨X线监视下激光碎石治疗难治性胆总管结石的效果和安全性.方法 将40例难治性胆总管结石患者分为两组,分别在子镜监视下（子镜监视组,21例）及X线监视下（X线监视组,19例）进行激光碎石治疗,比较两组间结石取净率、并发症发生率.结果 子镜监视组共取净结石19例（90.5%）,X线监视组取净17例（89.5%）,两组间结石取净率差异无统计学意义（P=0.658） 两组间并发症发生率差异无统计学意义（19.0%比15.8% P=0.559）.结论 治疗难治性胆总管结石X线监视与子镜监视两种方法是同样安全有效.     

Mechanical lithotripsy and/or stenting in management of difficult common bile duct stones

BACKGROUND:Mechanical lithotripsy and/or stent insertion is the alternative therapeutic approach in difficult endoscopic retrograde cholangiopancreatography (ERCP)case.This study was designed to investigate the appropriate treatment for extraction of bile duct stones in difficult cases of ERCP. METHODS:Between 2000 and 2008,744 ERCP procedures were performed in 592 patients with choledocholithiasis in our endoscopy unit.The demographic features,and clinical and laboratory findings were collected from a pros...     

Reappraisal of endoscopic papillary balloon dilation for the management of common bile duct stones

Although endoscopic sphincterotomy(EST) is still considered as a gold standard treatment for common bile duct(CBD) stones in western guideline, endoscopic papillary balloon dilation(EPBD) is commonly used by the endoscopists in Asia as the first-line treatment for CBD stones. Besides the advantages of a technical easy procedure, endoscopic papillary large balloon dilation(EPLBD) can facilitate the removal of large CBD stones.The indication of EPBD is now extended from removal of the small stones by using traditional balloon, to removal of large stones and avoidance of lithotripsy by using large balloon alone or after EST. According to the reports of antegrade papillary balloon dilatation, balloon dilation itself is not the cause of pancreatitis. On the contrary, adequate dilation of papillary orifice can reduce the trauma to the papilla and pancreas by the basket or lithotripter during the procedure of stone extraction. EPLBD alone is as effective as EPLBD with limited EST. Longer ballooning time may be beneficial in EPLBD alone to achieve adequate loosening of papillary orifice. The longer ballooning time does not increase the risk of pancreatitis but may reduce the bleeding episodes in patients with coagulopathy. Slowly inflation of the balloon, but not exceed the diameter of bile duct and tolerance of the patients are important to prevent the complication of perforation. EPBLD alone or with EST are not the sphincter preserved procedures, regular follow up is necessary for early detection and management of CBD stones recurrence.     

Endoscopic treatment of difficult extrahepatic bile duct stones,EPBD or EST: An anatomic view

Large bile duct stone( 10 mm) or multiple stones(≥ 3) are challenging for endoscopists. Endoscopic sphincterotomy(EST) is a routine therapeutic endoscopic retrograde cholangiopancreatography(ERCP) procedure usually used. It is safe and effective, but severe perforation or massive bleeding are the main causes of mortality. Because of the permanent destroy ofOddi sphincter, the use of EST is still controversial. Endoscopic papillary balloon dilation(EPBD) gives another way to open the sphincter. Less incidence of bleeding, perforation and partly preserving the Oddi sphincter's function are the main advantages. But high incidence of post-ERCP pancreatitis becomes a predominant problem. According to the anatomical feature of Oddi sphincter, limited EST + EPBD seems a more reasonable procedure. Compared to the former two procedures, it makes the stone extraction process much easier with lower incidences of short-term and long-term complications.     

Laparoscopic management of common bile duct stones

We reviewed our experience with the management of common bile duct (CBD) stones in 100 consecutive patients treated laparoscopicaly during the past 9 years (1990—1998) and evaluated the advantages, disadvantages, and feasibility of the treatment, to elucidate reasonable therapeutic strategies for patients harboring CBD stones. We conclude that the most rational management of CBD stones is that which is decided according to the size of the CBD, which, in turn, depends on the size, number, and location of stones. The cystic duct in patients with a non‐dilated CBD is narrow, because the size of the CBD depends on the size and number of stones that have migrated through the narrow cystic duct, and the stones in the non‐dilated CBD are therefore usually small in size and number. Patients with a dilated CBD, however, are good candidates to undergo single‐stage laparoscopic treatment. In our Department, therefore, even if complete removal of stones has failed in patients with non‐dilated CBD, further choledochotomy is not carried out, and a C‐tube is placed through the cystic duct for a subsequent postoperative transduodenal approach, because laparoscopic transcystic CBD exploration and choledochotomy may not be always feasible in those patients with non‐dilated CBD, and spontaneous migration of small stones into the duodenum is frequently noted. In fact, some stones demonstrated on intraoperative cholangiograms were not revealed by postoperative cholangiography. In contrast, retained stones detected postoperatively were successfully removed by postoperative endoscopic sphincterotomy (EST), the endoscopic papillary balloon dilatation technique (EPBDT), or postoperative cholangioscopy (POCS) without any injury to the sphinter of Oddi. With this approach, we believe that the causes of stone recurrence can be avoided in the majority of cases.     

Comparing the treatment outcomes of endoscopic papillary dilation and endoscopic sphincterotomy for removal of bile duct stones

To compare the clinical usefulness of endoscopic papillary dilation (EPD) and endoscopic sphincterotomy (EST) for removal of bile duct stones, 110 patients with stones up to 15 mm in diameter and less than 10 in number were randomly treated with either EPD (55 patients) or EST (55 patients). The patients were followed up for a median period of 23 months and endoscopic manometry with the administration of morphine was carried out in 17 patients who were observed more than 12 months after the procedures to evaluate the post-procedure papillary function. Duct clearance was achieved in 51 EPD (92.7%) and 54 EST patients (98.1%, not significantly different). Forty EPD (78.4%) and 51 EST patients (94.4%) achieved duct clearance in the initial procedure (P=0.02). Early complications occurred in one EPD (2.0%) and in three EST patients (5.6%, P=0.62). Complications during the follow-up period occurred in two EPD and eight EST patients. Recurrence of bile duct stones was observed in two EPD and three EST patients (P=0.98). Acute cholecystitis was observed in one EPD and five EST patients (P=0.06) and among patients with gall-bladder stones in situ, the rate of acute cholecystitis after EPD was significantly lower than that after EST (P=0.03). Endoscopic manometry showed the existence of a choledochoduodenal pressure gradient only after EPD, while papillary contractile function was observed after both procedures. In conclusion, both EPD and EST are safe therapeutic modalities, although EPD is more clinically effective in decreasing the risk of acute cholecystitis in patients with gall-bladder stones in situ and in preserving post-procedure papillary function.     

Endoscopic papillary large balloon dilation vs endoscopic sphincterotomy for retrieval of common bile duct stones:A meta-analysis

AIM:To compare the efficacy and safety of endoscopic papillary large balloon dilation(EPLBD)with endoscopic sphincterotomy(EST)in retrieval of common bile duct stones(≥10 mm).METHODS:PubMed,Web of Knowledge,EBSCO,the Cochrane Library,and EMBASE were searched for eligible studies.Randomized controlled trials(RCTs)that compared EPLBD with EST were identified.Data extraction and quality assessment were performed by two independent reviewers using the same criteria.Any disagreement was discussed with a third reviewer until a final consensus was reached.Pooled outcomes of complete bile duct stone clearance,stone clearance in one session,requirement for mechanical lithotripsy,and overall complication rate were determined using relative risk and 95%CI.The separate post-endoscopic retrograde cholangiopancreatography complications were pooled and determined with the Peto odds ratio and95%CI because of the small number of events.Heterogeneity was evaluated with the chi-squared test with P≤0.1 and I2 with a cutoff of≥50%.A fixed effects model was used primarily.A random effects model was applied when significant heterogeneity was detected.Sensitivity analysis was applied to explore the potential bias.RESULTS:Five randomized controlled trials with 621participants were included.EPLBD compared with EST had similar outcomes with regard to complete stone removal rate(93.7%vs 92.5%,P=0.54)and complete duct clearance in one session(82.2%vs 77.7%,P=0.17).Mechanical lithotripsy was performed less in EPLBD in the retrieval of whole stones(15.5%vs25.2%,P=0.003),as well as in the stratified subgroup of stones larger than 15 mm(24.2%vs 40%,P=0.001).There was no statistically significant difference in the incidence of overall adverse events(7.9%vs 10.7%,P=0.25),post-ERCP pancreatitis(4.0%vs 5.0%,P=0.54),hemorrhage(1.7%vs 2.8%,P=0.32),perforation(0.3%vs 0.9%,P=0.35)or acute cholangitis(1.3%vs 1.3%,P=0.92).CONCLUSION:EPLBD could be advocated as an alternative to EST in the retrieval of large common bile duct stones.     

The ballooning time in endoscopic papillary balloon dilation for removal of bile duct stones: A systematic review and meta-analysis

Background:So far, there was no consensus regarding balloon dilation time in endoscopic papillary balloon dilation (EPBD). Thus, we conducted a systematic review and meta-analysis to compare the stone removal and overall complication rates of dilation of short and long duration with EPBD.Methods:The Cochrane Central Register of Controlled Trials (CENTRAL; Cochrane Library), Web of Science, EMBASE Databases, and PubMed were searched from their inception to December 1, 2019 for all articles regarding balloon dilation time in EPBD for removal of bile duct stones. The data were extracted and the methodology quality was assessed. Meta-analysis was performed using RevMan5.3 software.Results:Four studies involving a total of 1553 patients were included, 918 in the short dilation group and 635 in the long dilation group. The results of meta-analysis showed that there was no significant difference between the 2 different dilation groups in the complete stone removal in randomized controlled trails (RCTs) group (P = .10) and non-RCTs group (P = 0.45), mechanical lithotripsy requirement (RCTs: P = .92; non-RCTs: P = .47), pancreatitis (RCTs: P = .48; non-RCTs: P = .45), bleeding (RCTs: P = .95; non-RCTs: P = .60), infection of biliary (RCTs: P = .58; non-RCTs: P = .29), perforation (RCTs: P = .32; non-RCTs: P = .37).Conclusion:This systematic review suggests that there no significant difference in the efficacy and safety of dilation of short and long duration for removal of bile duct stones with EPBD.     

Papillary dilation vs sphincterotomy in endoscopic removal of bile duct stones a randomized trial with manometric function

To circumvent the long-term effects of papillary ablation for extracting common bile duct stones (<12 mm in diameter) in endoscopic sphincterotomy (EST), endoscopic papillary dilation (EPD) was attempted in 20 patients. To evaluate papillary function before and after the procedures, manometry of the sphincter of Oddi was carried out in 13 with EPD and 10 of 20 patients with EST. Extraction of all stones was successful (100%) in both groups at an equal rate. Repeated numbers of procedures were common in both groups. However, the mean duration of the procedure was high in EPD compared to EST (63 min vs 42 min,P<NS). Adjunctive therapies like mechanical lithotripsy (ML), nasobiliary drainage, and choledochoscopy were included in EPD, while EST required a basket catheter and ML. There was no significant difference on manometry before and after the procedures (P=NS), although papillary function was found to have decreased after the EPD. In contrast, all patients in the EST group lost papillary function after the procedure. Thirty-day morbidity and mortality rate were absent in both groups. Immediate and 2.5-year follow up complications were uncommon in both groups. As a simple method, EPD may be an effective and safe alternative to EST in the management of patients with bile duct stones who require maintenance of papillary function.