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.     

Small sphincterotomy combined with endoscopic papillary large balloon dilation versus sphincterotomy

AIM： To compare small sphincterotomy combined with endoscopic papillary large balloon dilation （SES ＋ ELBD） and endoscopic sphincterotomy （EST） for large bile duct stones. METHODS： We compared prospectively SES ＋ ELBD （group A, n = 27） with conventional EST （group B, n = 28） for the treatment of large bile duct stones （≥ 15 mm）. When the stone could not be removed with a normal basket, mechanical lithotripsy was performed. We compared the rates of complete stone removal with one session and application of mechanical lithotripsy. RESULTS： No significant differences were observed in the mean largest stone size （A： 20.8 mm, B： 21.3 mm）, bile duct diameter （A： 21.4 turn, B： 20.5 ram）, number of stones （A： 2.2, B： 2.3）, or procedure time （A： 18 min, B： 19 rain） between the two groups. The rates of complete stone removal with one session was 85% in group A and 86% in group B （P = 0.473）. Mechanical lithotripsy was required for stone removal in nine of 27 patients （33%） in group A and nine of 28 patients （32%, P = 0.527） in group B.CONCLUSION： SES ＋ ELBD did not show significant benefits compared to conventional EST, especially for the removal of large （≥ 15 mm） bile duct stones.     

Comparison between endoscopic sphincterotomy vs endoscopic sphincterotomy associated with balloon dilation for removal of bile duct stones: A systematic review and meta-analysis based on randomized controlled trials

AIM To compare gallstones removal rate and incidence of bleeding, pancreatitis, use of mechanical lithotripsy, cholangitis and perforation between isolated sphincterotomy vs sphincterotomy associated with balloon dilation of papilla in choledocholithiasis through the meta-analysis of randomized clinical trials. METHODS We conducted a systematic review according to the PRISMA guidelines. Literature search was restricted to randomized controlled trials(RCTs) on Med Line, Cochrane Library, LILACS, and EMBASE database platforms in July 2017. The manual search included references of retrieved articles. We extracted data focusing on outcomes: The primary endpoint was the stones removal rate; Secondary endpoints were rates of pancreatitis, bleeding, use of mechanical lithotripsy(ML), perforation and cholangitis. RESULTS Eleven RCTs with 1824 patients were included. EST was associated with more post-endoscopic retrograde cholangiopancreatography(ERCP) bleeding [FE RD-0.02, CI(-0.03,-0.00), I2 = 33%, P = 0.05] and more need of mechanical lithotripsy in general [RE RD-0.16, CI(-0.25,-0.06), I2 = 90%, P = 0.002] and in subgroup analysis of stones greater than 15 mm [RE RD-0.20, CI(-0.38,-0.02), I2 = 82%, P = 0.003]. Incidence of pancreatitis [FE RD-0.01, CI(-0.03, 0.01), I2 = 0, P = 0.36], cholangitis [FE RD-0.00, CI(-0.01, 0.01), I2 =0, P = 0.97] and perforation [FE RD-0.01, CI(-0.01, 0.00), I2 = 0, P = 0.23] was similar between the groups as well as similar stone removal rates in general [FE RD-0.01, CI(-0.01, 0.04), I2 = 0, P = 0.23] and pooled analysis of stones greater than 15 mm [FE RD-0.02, CI(-0.02, 0.07), I2 = 11%, P = 0.31]. CONCLUSION Through meta-analysis of randomized clinical trials we found that isolated sphincterotomy was associated with more post-ERCP bleeding and more need for mechanical lithotripsy. However, there was no statistical difference in the stone removal rate between isolated sphincterotomy and sphincterotomy associated with balloon dilation in the approach to remove gallstones.     

Limited endoscopic sphincterotomy plus large balloon dilation for choledocholithiasis with periampullary diverticula

AIM: To investigate the effectiveness and safety of limited endoscopic sphincterotomy (EST) plus large balloon dilation (LBD) for removing choledocholithiasis in patients with periampullary diverticula (PAD). METHODS: A total of 139 patients with common bile duct (CBD) stones were treated with LBD (10-20 mm balloon diameter) after limited EST. Of this total, 73 patients had PAD and 66 patients did not have PAD (controls). The results of stone removal and complications were retrospectively evaluated. RESULTS...     

Endoscopic papillary balloon dilatation versus endoscopic sphincterotomy in the treatment for choledocholithiasis: a meta-analysis

Background and Aim: Endoscopic papillary balloon dilatation (EPBD) and endoscopic sphincterotomy (EST) are two common nonsurgical treatments endoscopic retrograde cholangiopancreatography (ERCP) for choledocholithiasis. The aim of this study was to compare the efficacy and safety of EPBD and EST in the treatment for choledocholithiasis, confining the analysis to work reported in the last decade. Methods: The rate of overall postoperative complications was chosen as the primary outcome, and 10 other outcomes were secondary outcomes. Relative risk (RR) or Peto odds ratio (OR) were computed as the measures of pooled effects. We planned sensitivity analyses a priori for examining the change in robustness of the sensitivity to excluding studies with some inappropriate objects, technique defects or without full‐text acquisition. Results: For complete stone removal, EPBD was similar to EST (95% vs. 96%, P = 0.36) and overall postoperative complications (14.0% vs. 11.7%, P = 0.53). The incidence of post‐ERCP cholangitis (2.5% vs. 1.8%, P = 0.40), basket impaction (0.9% vs. 0%, P = 0.16) and perforation (0.0% vs. 0.4%, P = 0.17) were equivalent between EPBD and EST. On the other hand, EPBD caused more post‐ERCP pancreatitis (PEP) (9.4% vs. 3.3%, P < 0.00001), but less hemorrhage (0.1% vs. 4.2%, P < 0.00001). People undergoing EPBD required more use of endoscopic mechanical lithotripsy (35.0% vs. 26.2%, P = 0.0004). The results of sensitivity analyses showed no substantial change. Conclusion: EPBD is comparable to EST for stone extraction, though it requires more endoscopic mechanical lithotripsy (EML). EPBD may outweigh EST for patients with coagulopathy; however, it may cause more PEP.     

Endoscopic sphincterotomy plus large-balloon dilation vs endoscopic sphincterotomy for choledocholithiasis:A meta-analysis

AIM:To perform a meta-analysis of large-balloon dilation(LBD)plus endoscopic sphincterotomy(EST)vs EST alone for removal of bile duct stones.METHODS:Databases including PubMed,EMBASE,the Cochrane Library,the Science Citation Index,and important meeting abstracts were searched and evaluated by two reviewers independently.The main outcome measures included:complete stone removal,stone removal in the first session,use of mechanical lithotripsy,procedure time,and procedure-related complications.A fixed-effects model weighted by the Mantel-Haenszel method was used for pooling the odds ratio(OR)when heterogeneity was not significant among the studies.When a Q test or I2statistic indicated substantial heterogeneity,a random-effects model weighted by the DerSimonian-Laird method was used.RESULTS:Six randomized controlled trials involving835 patients were analyzed.There was no significant heterogeneity for most results;we analyzed these using a fixed-effects model.Meta-analysis showed EST plus LBD caused fewer overall complications than EST alone(OR=0.53,95%CI:0.33-0.85,P=0.008);sub-category analysis indicated a significantly lower risk of perforation in the EST plus LBD group(Peto OR=0.14,95%CI:0.20-0.98,P=0.05).Use of mechanical lithotripsy in the EST plus LBD group decreased significantly(OR=0.26,95%CI:0.08-0.82,P=0.02),especially in patients with a stone size larger than 15 mm(OR=0.15,95%CI:0.03-0.68,P=0.01).There were no significant differences between the two groups regarding complete stone removal,stone removal in the first session,post-endoscopic retrograde cholangiopancreatography pancreatitis,bleeding,infection of biliary tract,and procedure time.CONCLUSION:EST plus LBD is an effective approach for the removal of large bile duct stones,causing fewer complications than EST alone.     

Endoscopic papillary balloon dilation and endoscopic sphincterotomy for bile duct stones: long-term outcomes in a prospective randomized controlled trial

BACKGROUND: Little is known about the long-term outcome of endoscopic papillary balloon dilation for removal of bile duct stones. A randomized trial that compared long-term outcomes after endoscopic papillary balloon dilation and endoscopic sphincterotomy was conducted. METHODS: Thirty-two patients with bile duct stones were randomized to endoscopic papillary balloon dilation or endoscopic sphincterotomy, with 16 patients in each group. Endoscopic papillary balloon dilation was performed by using an 8-mm-diameter balloon; endoscopic sphincterotomy was performed in the standard manner. The success rates for stone removal, as well as the frequency and types of early (<15 days), mid-term (<1 year), and long-term (1-6 years) post-procedure complications were evaluated. RESULTS: The success rates for stone removal and early complication rates were similar for both groups. The frequency of stone recurrence was approximately 4-fold higher in the endoscopic papillary balloon dilation group (25%) vs. the endoscopic sphincterotomy group (6.3%) at mid-term evaluation. However, over the long term, Kaplan-Meier estimated probability of stone recurrence tended to be higher in the endoscopic sphincterotomy group vs. the endoscopic papillary balloon dilation group; recurrent stones were found in, respectively, 26.7% vs. 6.3%. Complications occurred in 7 patients in each group. CONCLUSIONS: Long-term outcome of endoscopic papillary balloon dilation for bile duct stone removal is satisfactory, provided that consideration is given to recurrence of stones by early follow-up evaluation.     

Nasobiliary drainage can reduce the incidence of post-ERCP pancreatitis after papillary large balloon dilation plus endoscopic biliary sphincterotomy: a randomized controlled trial

Background and aims: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis can be reduced following endoscopic papillary balloon dilation with the placement of an endoscopic nasobiliary drainage (ENBD) catheter. The aim of this study was to determine whether the placement of an ENBD reduces the risk of post-ERCP pancreatitis following endoscopic papillary large balloon dilation together with endoscopic biliary sphincterotomy.

Methods: A total of 160 patients with bile duct stones were randomly assigned (1:1) to an ENBD group or no-ENBD group. The primary outcome of this study was the incidence of post-ERCP pancreatitis. The secondary outcome was the incidence of post-ERCP hyperamylasemia.

Results: In total, 160 patients were randomized, and 155 were found to be eligible for the analysis. The two groups were similar regarding clinical and demographic factors as well as patient- and procedure-related risk factors for post-ERCP pancreatitis. Post-ERCP pancreatitis developed in 9 patients, that is, 8/77 (10.4%) of the control group and 1/78 (1.28%) of the ENBD group (p?=?.018; per protocol analysis). Intention to treat analysis also revealed that ENBD reduced the rate of post-ERCP pancreatitis (8/80 (10%) in the control group vs. 1/80 (1.25%) the ENBD group (p?=?.034)). Multivariate regression analysis identified not undergoing ENBD as an independent risk factor for post-ERCP pancreatitis (ENBD compared with no-ENBD: OR 0.087, 95% CI 0.011–0.734; p?=?.025).

Conclusion: This study demonstrated that placement of an ENBD was effective and safe for the prevention of post-ERCP pancreatitis in patients undergoing endoscopic papillary large balloon dilation together with endoscopic biliary sphincterotomy.     

Endoscopic sphincterotomy vs. endoscopic papillary balloon dilation for choledocholithiasis in patients with liver cirrhosis and coagulopathy

BACKGROUND: To determine whether endoscopic papillary balloon dilation decreases the risk of hemorrhage without increasing the risk of acute pancreatitis, the results of endoscopic papillary balloon dilation were compared with those of endoscopic biliary sphincterotomy in patients with cirrhosis and coagulopathy. METHODS: Twenty-one patients with liver cirrhosis with coagulopathy had endoscopic papillary balloon dilation for choledocholithiasis from January 2001 to September 2003. Twenty patients with cirrhosis and coagulopathy who underwent endoscopic biliary sphincterotomy from January 1998 to December 2000, served as a historical control group. RESULTS: The rate of endoscopic biliary sphincterotomy related hemorrhage was 30% (6/20), whereas the rate for endoscopic papillary balloon dilation related hemorrhage was 0% (p=0.009). With regard to rates of hemorrhage in relation to Child-Pugh class, most (n=5) of the bleeding complications occurred in patients with Child-Pugh class C cirrhosis; bleeding occurred in only one patient with Child-Pugh B cirrhosis. There was no significant difference between the endoscopic biliary sphincterotomy and the endoscopic papillary balloon dilation groups for procedure-related pancreatitis (10% vs. 4.7%, respectively; p>0.05). CONCLUSIONS: Endoscopic papillary balloon dilation may significantly reduce the risk of bleeding compared with endoscopic biliary sphincterotomy in patients with advanced cirrhosis and coagulopathy. In these patients, the substitution of endoscopic papillary balloon dilation for endoscopic biliary sphincterotomy is recommended for treatment of choledocholithiasis.     

Comparison of long-term outcomes after endoscopic sphincterotomy versus endoscopic papillary balloon dilation: a propensity score-based cohort analysis

Background

Endoscopic sphincterotomy (ES) is widely performed in patients with common bile duct stones (CBDS). However, the long-term outcomes of patients following ES have not been sufficiently elucidated. Impaired papillary function following ES may result in additional late complications. In contrast, endoscopic papillary balloon dilation (EPBD)—another option for treating CBDS—is expected to preserve papillary function. This study aimed to compare the long-term outcomes of patients with CBDS treated with ES to those treated with EPBD in a large cohort. In addition, a subgroup analysis was performed, according to gallbladder (GB) status.

Methods

A cohort study was performed using propensity score matching to reduce treatment selection bias. This involved the analysis of follow-up data for 1086 patients who underwent EPBD or ES for CBDS.

Results

Propensity score matching extracted 246 pairs of patients. The median (interquartile range) follow-up period after EPBD or ES was 93.5 (46.8–129.2) months and 90 (42–139.3) months, respectively. The incidence of CBDS recurrence after EPBD and ES were 8.5 and 15.0 %, respectively. The hazard ratio (95 % CI) was 0.577 (0.338–0.986) (P = 0.044). Based on the status of the GB, the incidence of CBDS recurrence was significantly different between post-EPBD and post-ES in the group with cholecystectomy after EPBD/ES (P = 0.013).

Conclusions

The incidence of biliary complications was significantly lower in patients after EPBD than in those after ES, and this outcome appeared most markedly in patients who also underwent cholecystectomy.     

Small sphincterotomy combined with endoscopic papillary large balloon dilation vs sphincterotomy alone for removal of common bile duct stones

AIM: To evaluate the efficacy and safety of endoscopic papillary large diameter balloon dilation (EPLBD) following limited endoscopic sphincterotomy (EST) and EST alone for removal of large common bile duct (CBD) stones.METHODS: We retrospectively compared EST + EPLBD (group A, n = 64) with EST alone (group B, n = 89) for the treatment of large or multiple bile duct stones. The success rate of stone clearance, procedure-related complications and incidents, frequency of mechanical lithotripsy use, and recurrent stones were recorded.RESULTS: There was no statistically significant difference between the two groups regarding periampullary diverticula (35.9% vs 34.8%, P > 0.05), pre-cut sphincterotomy (6.3% vs 6.7%, P > 0.05), size (12.1 ± 2.0 mm vs 12.9 ± 2.6 mm, P > 0.05) and number (2.2 ± 1.9 vs 2.4 ± 2.1, P > 0.05) of stones or the diameters of CBD (15.1 ± 3.3 mm vs 15.4 ± 3.6 mm, P > 0.05). The rates of overall stone removal and stone removal in the first session were not significantly different between the two groups [62/64 (96.9%) vs 84/89 (94.4%), P > 0.05; and 58/64 (90.6%) vs 79/89 (88.8%), P > 0.05, respectively]. The rates of post-endoscopic retrograde cholangiopancreatography pancreatitis and hyperamylasemia were not significantly different between the two groups [3/64 (4.7%) vs 4/89 (4.5%), P > 0.05; 7/64 (10.9%) vs 9/89 (10.1%), P > 0.05, respectively]. There were no cases of perforation, acute cholangitis, or cholecystitis in the two groups. The rate of bleeding and the recurrence of CBD stones were significantly lower in group A than in group B [1/64 (1.6%) vs 5/89 (5.6%), P < 0.05; 1/64 (1.6%) vs 6/89 (6.7%), P < 0.05, respectively].CONCLUSION: EST + EPLBD is an effective and safe endoscopic approach for removing large or multiple CBD stones.     

Sixty- versus thirty-seconds papillary balloon dilation after sphincterotomy for the treatment of large bile duct stones: A randomized controlled trial

BackgroundEndoscopic biliary sphincterotomy followed by endoscopic papillary balloon dilation is a promising method for large stones. However, there are no data on the optimal duration of papillary balloon dilation after a biliary sphincterotomy.AimsTo compare the effectiveness and complications of the endoscopic papillary balloon dilation for 60 s versus 30 s after endoscopic biliary sphincterotomy.MethodsA total of 124 patients with bile duct stones, submitted for endoscopic biliary sphincterotomy plus endoscopic papillary balloon dilation, were prospectively randomized to either the 60-s dilation group (G60, n = 60) or the 30-s dilation group (G30, n = 64).ResultsThe complete removal of bile duct stones was similar: group G30, 55/64 (86%) versus group G60, 51/60 (85%); p = 0.9. The rates of post-endoscopic retrograde cholangio-pancreatography pancreatitis were also similar: 2 (3.1%) in group G30 versus 2 (3.3%) in group G60, p = 0.9. Post-procedural bleeding occurred in 2 cases (3.1%) in group G30 versus 4 (6.6%) in group G60, (p = 0.17). Two perforations of moderate severity were observed, one in each group.Conclusions30-s papillary balloon dilation, performed after endoscopic biliary sphincterotomy for the management of bile duct stones, was equally effective to the 60-s papillary balloon dilation.     

Small sphincterotomy combined with papillary dilation with large balloon permits retrieval of large stones without mechanical lithotripsy

AIM： TO introduce a new method： small endoscopic sphincterotomy （ES） combined with endoscopic papillary large balloon dilation （SES ＋ EPLBD） to treat patients with large biliary stones.
METHODS： Retrieval of large biliary stones was performed in 88 patients. Mean stone size was 14 ± 3 mm and mean number of stones was 2.5 ± 3.5. Firstly, ES with a small incision was performed. Next, endoscopic papillary dilation was performed with a large balloon to slowly match the size of the bile duct. Stones were then retrieved from the biliary duct with a balloon and a basket.
RESULTS： Stone retrieval was successful in all cases except one cystic duct stone case without the need to crush large stones. Mean procedure time was 30 ± 5 min. Dilating the papillary orifice with a large balloon made it possible to remove large stones smoothly without crushing them. After dilation with the large balloon, there were some instances of oozing, but no perforations. One instance of post-procedural pancreatitis （1%） occurred.
CONCLUSION： SES ＋ EPLBD was effective for the retrieval of large biliary stones without the use of mechanical lithotripsy.     

Minor endoscopic sphincterotomy followed by large balloon dilation for large choledocholith treatment

AIM To evaluate early and late outcomes of endoscopic papillary large balloon dilation(EPLBD) with minor endoscopic sphincterotomy(m EST) for stone removal.METHODS A total of 149 consecutive patients with difficult common bile duct(CBD) stones(diameter ≥ 10 mm or ≥ 3 stones) underwent conventional endoscopic sphincterotomy(EST) or m EST plus EPLBD from May 2012 to April 2016. Their demographic, laboratory and procedural data were collected, and pancreaticobiliary complications were recorded.RESULTS Sixty-nine(94.5%) of the patients in the EPLBD + m EST group and 64(84.2%) in the conventional EST group achieved stone clearance following the first session(P = 0.0421). The procedure time for EPLBD + m EST was shorter than for EST alone(42.1 ± 13.6 min vs 47.3 ± 11.8 min, P = 0.0128). The overall rate of early complications in the EPLBD + m EST group(11%) was lower than in the EST group(21.1%); however, the difference was not significant(P = 0.0938). The cumulative recurrence rate of cholangitis and CBD stones between the two groups was also similar. The procedure time was independently associated with post-endoscopic retrograde cholangiopancreatography pancreatitis(OR = 6.374, 95%CI: 1.193-22.624, P = 0.023), CBD stone diameter ≥ 16 mm(OR = 7.463, 95%CI: 2.705-21.246, P = 0.0452) and use of mechanical lithotripsy(OR = 9.913, 95%CI: 3.446-23.154, P = 0.0133) were independent risk factors for stone recurrence. CONCLUSION EPLBD with m EST is more effective than EST alone for difficult CBD stone removal, with shorter procedure time and fewer early complications.     

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.