Endoscopic papillary large balloon dilation for removal of bile duct stones

AIM:To investigate the efficacy and outcomes of endoscopic papillary large balloon dilation(EPLBD)for bile duct stones in a multicenter prospective study.METHODS:Lithotomy by EPLBD was conducted in 124patients with bile duct stones≥13 mm in size or with three or more bile duct stones≥10 mm.After endoscopic sphincterotomy,the papilla was dilated using balloons 12-20 mm in diameter fitting the bile duct diameter.RESULTS:The success rate of first-time lithotomy was 86.3%(107/124)and the final lithotomy success rate was 100%(124/124).Lithotripsy was needed in10 of the 124(13.6%)patients.Adverse events due to the treatment procedure occurred in 6(4.8%)patients,all of which were mild.Performing large balloon dilation after endoscopic sphincterotomy in patients with large stones or multiple stones in the bile duct is considered to ensure the safety of treatment and to reduce the need for lithotripsy.CONCLUSION:It is suggested that treatment by EPLBD for large bile duct stones may be safe and useful.     

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.     

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.     

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.     

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.     

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.     

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.     

Ampulla dilation with different sized balloons to remove common bile duct stones

AIM:To assess the outcomes of ampulla dilation with different sized balloons to remove common bile duct (CBD) stones.METHODS:Patients (n=208) were divided into five groups based on the largest CBD stone size of < 5,6-8,8-12,12-14,and > 14 mm.Patients underwent limited endoscopic sphincterotomy (EST) alone or limited EST followed by endoscopic papillary balloon dilation with 8,10,12 and 14 mm balloons,such that the size of each balloon did not exceed the size of the CBD.Short-and long-term outcomes,such as post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis,perforation,bleeding,and pneumobilia were compared among the five groups.RESULTS:The overall rate of successful stone removal in all groups was 100%,and all patients were cured.Eight (3.85%) patients had post-ERCP pancreatitis,none had perforations,and 6 (2.9%) had bleeding re-quiring transfusion.There were no significant differences in early complication rates among the five groups.We observed significant correlations between increased balloon size and the short-and long-term rates of postERCP pneumobilia.Post-ERCP pancreatitis and bleeding correlated significantly with age,with post-ERCP pancreatitis occurring more frequently in patients aged < 60 years,and bleeding occurring more frequently in patients aged > 70 years.We observed a significant correlation between patient age and the diameter of the largest CBD stone,with stones > 12 mm occurring more frequently in patients > 60 years old.CONCLUSION:Choosing a balloon size based on the largest stone diameter is safe and effective for removing CBD stones.Balloon size should not exceed 15 mm.     

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.     

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.     

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.     

Comparison of endoscopic papillary balloon dilatation and endoscopic sphincterotomy for bile duct stones

Endoscopic treatment for bile duct stones is low-invasive and currently considered as the first choice of the treatment. For the treatment of bile duct stones, papillary treatment is necessary, and the treatments used at the time are broadly classified into two types; endoscopic papillary balloon dilatation where bile duct closing part is dilated with a balloon and endoscopic sphincterotomy(EST) where bile duct closing part is incised. Both procedures have advantages and disadvantages. Golden standard is EST, however, there are patients with difficulty for EST, thus we must select the procedure based on understanding of the characteristics of the procedure, and patient backgrounds.     

Endoscopic papillary balloon intermittent dilatation and endoscopic sphincterotomy for bile duct stones

AIM: To compare the effectiveness and safety of endoscopic papillary balloon intermittent dilatation (EPBID) and endoscopic sphincterotomy (EST) in the treatment of common bile duct stones. METHODS: From March 2011 to May 2012, endoscopic retrograde cholangiopancreatography was performed in 560 patients, 262 with common bile duct stones. A total of 206 patients with common bile duct stones were enrolled in the study and randomized to receive either EPBID with a 10-12 mm dilated balloon or EST (103 patients in each group). For both groups a conventional reticular basket or balloon was used to remove the stones. After the procedure, routine endoscopic nasobiliary drainage was performed. RESULTS: First-time stone removal was successfully performed in 94 patients in the EPBID group (91.3%) and 75 patients in the EST group (72.8%). There was no statistically significant difference in terms of operation time between the two groups. The overall incidence of early complications in the EPBID and EST groups was 2.9% and 13.6%, respectively, with no deaths reported during the course of the study and follow-up. Multiple regression analysis showed that the success rate of stone removal was associated with stone removal method [odds ratio (OR): 5.35; 95%CI: 2.24-12.77; P=0.00], the transverse diameter of the stone (OR: 2.63; 95%CI: 1.19-5.80; P=0.02) and the presence or absence of diverticulum (OR: 2.35; 95%CI: 1.03-5.37; P=0.04). Postoperative pancreatitis was associated with the EST method of stone removal (OR: 5.00; 95%CI: 1.23-20.28; P=0.02) and whether or not pancreatography was performed (OR: 0.10; 95%CI: 0.03-0.35; P=0.00). CONCLUSION: The EPBID group had a higher success rate of stone removal with a lower incidence of pancreatitis compared with the EST group.     

Endoscopic papillary large balloon dilation in Billroth II gastrectomy patients with bile duct stones

Background and Aims: Patients with Billroth II (B‐II) gastrectomy present technical difficulties during endoscopic stone removal due to altered anatomy. Although endoscopic sphincterotomy alone or endoscopic balloon dilation alone has been used for removal of bile duct stones in patients with B‐II gastrectomy, the results are not satisfactory. The aim of this study was to evaluate the efficacy and safety of endoscopic papillary large balloon dilation (EPLBD) for removal of bile duct stones in patients with B‐II gastrectomy. Methods: Twenty‐six patients (20 men and six women; median age 72 years) with bile duct stones and a history of B‐II gastrectomy were enrolled. After cannulation, limited endoscopic sphincterotomy was performed. Then, balloon dilation (balloon size, 10–15 mm) was performed and stones were removed conventionally or via mechanical lithotripsy. Successful stone removal and complications were evaluated. Results: In all cases, stones were successfully removed. The median number of sessions for complete stone removal was one (range 1–3). Stone removal by mechanical lithotripsy was achieved in three patients (11.5%). There were no significant complications, such as bleeding, pancreatitis, or perforation. Conclusions: Endoscopic papillary large balloon dilation is an effective and safe method for removal of bile duct stones. We suggest consideration of this technique for removal of bile duct stones in patients with B‐II gastrectomy.     

经内镜乳头括约肌切开术与气囊扩张术治疗胆总管结石临床评价

目的:评价经内镜乳头括约肌切开术(EST)和气囊扩张术(EPBD)联合机械碎石(EML)治疗胆总管结石的临床疗效．方法:选取我院住院胆总管结石患者60例,随机分成EST组(n=30)和EPBD组(n=30),分别采用EST和EPBD联合机械碎石进行内镜下取石．观察二组的治愈率,近期并发症、远期并发症．结果:正结果EST组与EPBD组的取石成功率为93．3％和90％．无显著性差异(P>0．05): 两组近期并发症发生率(包括胰腺炎、胆道感染、出血)为30％和13．3％,无显著性差异 (P>0．05);而远期并发症(包括胆道感染、结石复发)26．7％和3.3％,有显著性差异(P<0．05)．结论:EST和EPBD的结石清除率及近期并发症相似,但EPBD远期并发症的发病率较低, 表明EPBD能够在一定程度上保护Oddi括约肌功能。     

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.