Safety Of Endoscopic Sphincterotomy Research Articles

The efficacy and safety of endoscopic sphincterotomy in patients with Sphincter of Oddi dysfunction: a systematic review and meta-analysis.

Sphincter of Oddi dysfunction (SOD) has been used to describe patients with RUQ abdominal pain without an etiology. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of ES (endoscopic sphincterotomy) for SOD. The study methodology follows the PRISMA guidelines. A comprehensive search was conducted using MEDLINE and EMBASE databases for RCTs with ES in patients with SOD. The primary outcome assessed was the improvement of abdominal pain after ES/sham. A random effects model was used to calculate pooled estimates for each outcome of interest. Of the initial 55 studies, 23 were screened and thoroughly reviewed. The final analysis included 3 studies. 340 patients (89.7% women) with SOD were included. All patients had a cholecystectomy. Most included patients had SOD type II and III. The pooled rate of technical success of ERCP was 100%. The average clinical success rate was 50%. The pooled cumulative rate of overall AEs related to all ERCP procedures was 14.6%. In the sensitivity analysis, only one study significantly affected the outcome or the heterogeneity. ES appears no better than placebo in patients with SOD type III. Sphincterotomy could be considered in patients with SOD type II and elevated SO basal pressure.

Efficacy and safety of endoscopic sphincterotomy with balloon dilation versus endoscopic sphincterotomy alone for extraction of common bile duct stones with a maximum diameter of 10 to15 millimeters.

Various factors, most notably the stone's features, determine the selection of an appropriate methodto extract common bile duct (CBD) stones during endoscopic retrograde cholangiopancreatography. In this study, the efficacy and safety of endoscopic sphincterotomy with balloon dilation (ESBD) versus endoscopic sphincterotomy (EST) for CBD stone extraction with a diameter of 10 to 15 millimeters were compared. This retrospective cross-sectional study included 154 patients referred to the Rouhani Hospital in Babol, Iran, with CBD stones. Consensus sampling was used. Each individual's demographic information and findings from the procedure were entered into the SPSS software (v. 26). A level of less than 0.05 was considered statistically significant. A total of 154 patients were included in the study, of which 81 (52.6%) were in the EST, and 73 (47.4%) were in the ESBD group. Complete stones removal rate was higher in the ESBD versus the EST group (79.5% versus 46.9%, P<0.001). No significant differences were observed between the two methods' overall side effects rate (P = 0.469). For the complete extraction of CBD stones larger than 10 millimeters, the ESBD method outperforms the EST method.

Effectiveness and safety of endoscopic sphincterotomy and papillary balloon dilatation in treatment of extrahepatic bile duct stones

Effectiveness and safety of endoscopic sphincterotomy and papillary balloon dilatation in treatment of extrahepatic bile duct stones

Endoscopic papillary balloon dilation after sphincterotomy for difficult choledocholithiasis: A case-controlled study

To evaluate the efficacy and safety of endoscopic sphincterotomy (EST) + endoscopic papillary large balloon dilation (EPLBD) vs isolated EST. We conducted a retrospective single center study over two years, from February 2010 to January 2012. Patients with large (≥ 10 mm), single or multiple bile duct stones (BDS), submitted to endoscopic retrograde cholangio-pancreatography (ERCP) were included. Patients in Group A underwent papillary large balloon dilation after limited sphincterotomy (EST+EPLBD), using a through-the-scope balloon catheter gradually inflated to 12-18 mm according to the size of the largest stone and the maximal diameter of the distal bile duct on the cholangiogram. Patients in Group B (control group) underwent isolated sphincterotomy. Stones were removed using a retrieval balloon catheter and/or a dormia basket. When necessary, mechanical lithotripsy was performed. Complete clearance of the bile duct was documented with a balloon catheter cholangiogram at the end of the procedure. In case of residual lithiasis, a double pigtail plastic stent was placed and a second ERCP was planned within 4-6 wk. Some patients were sent for extracorporeal lithotripsy prior to subsequent ERCP. Outcomes of EST+EPLBD (Group A) vs isolated EST (Group B) were compared regarding efficacy (complete stone clearance, number of therapeutic sessions, mechanical and/or extracorporeal lithotripsy, biliary stent placement) and safety (frequency, type and grade of complications). Statistical analysis was performed using χ(2) or Fisher's exact tests for the analysis of categorical parameters and Student's t test for continuous variables. A P-value of less than 0.05 was considered statistically significant. One hundred and eleven patients were included, 68 (61.3%) in Group A and 43 (38.7%) in Group B. The mean diameter of the stones was similar in the two groups (16.8 ± 4.4 and 16.0 ± 6.7 in Groups A and B, respectively). Forty-eight (70.6%) patients in Group A and 21 (48.8%) in Group B had multiple BDS (P = 0.005). Overall, balloon dilation was performed up to 12 mm in 10 (14.7%) patients, 13.5 mm in 17 (25.0%), 15 mm in 33 (48.6%), 16.5 mm in 2 (2.9%) and 18 mm in 6 (8.8%) patients, taking into account the diameter of the largest stone and that of the bile duct. Complete stone clearance was achieved in sixty-five (95.6%) patients in Group A vs 30 (69.8%) patients in Group B, and was attained within the first therapeutic session in 82.4% of patients in Group A vs 44.2% in Group B (P < 0.001). Patients submitted to EST+EPLBD underwent fewer therapeutic sessions (1.1 ± 0.3 vs 1.8 ± 1.1, P < 0.001), and fewer required mechanical (14.7% vs 37.2%, P = 0.007) or extracorporeal (0 vs 18.6%, P < 0.001) lithotripsy, as well as biliary stenting (17.6% vs 60.5%, P < 0.001). The rate of complications was not significantly different between the two groups. EST+EPLBD is a safe and effective technique for treatment of difficult BDS, leading to high rates of complete stone clearance and reducing the need for lithotripsy and biliary stenting.

Efficacy and safety of sphincterotomy with sphincteroplasty using large caliber balloons in the treatment of choledocholithiasis with extraction difficulties

Introduction: Endoscopic retrograde cholangiopan-creatography (ERCP) with endoscopic sphincterotomy (ES) is the most widely used technique for treating choledocholithiasis. In some cases, due to anomalies of the papilla or the presence of large or multiple calculi, additional maneuvers are needed to remove the stones. The present study investigates the efficacy and safety of ES with sphincteroplasty (SP) in the management of choledocholithiasis with extraction difficulties. Patients and Methods: A prospective study was made of 153 patients with choledocholithiasis subjected to ERCP. Fifty-two patients underwent ES with SP, while 101 were subjected only to ES. The two groups were compared in terms of age, gender, percentage cannulation, presence of papilla alterations, large or multiple stones, success in stone removal and complications (acute pancreatitis, bleeding and perforation). In the ES with SP group, we moreover recorded the diameters of the balloons employed (10-18 mm). Results: There were no significant differences between the groups in the stone extraction success rate (94.23% in the ES with SP group versus 97.03% in the ES group) or in the appearance of complications (3.8% in the ES with SP group versus 2.7% in the ES group). The presence of difficult papillae, and of multiple or large stones was significantly greater in the ES with SP group. The diameter of the balloon was not associated with the appearance of complications. Conclusion: Endoscopic sphincterotomy with sphincteroplasty is effective and safe in the treatment of choledocholithiasis with extraction difficulties.

Safety of endoscopic sphincterotomy in patients under dual antiplatelet therapy.

Dual antiplatelet therapy has to be used for at least one month after placement of bare metal coronary stents and for a minimum of one year after placement of drug eluting stents. Because of the higher risk of bleeding, guidelines strongly recommend to delay elective surgery until dual antiplatelet therapy is terminated. However, no data are available regarding the bleeding risk in patients on combined aspirin/clopidogrel therapy undergoing high-risk endoscopic procedures, such as emergency endoscopic biliary sphincterotomy. We retrospectively analyzed the medical reports of patients who had to undergo endoscopic retrograde cholangiography with endoscopic sphincterotomy (ES) while on dual antiplatelet therapy in our unit between January 2009 and December 2011. In our series, ES was safely performed in eight consecutive patients on dual antiplatelet therapy with no evidence of bleeding. ES may be safely performed in patients on dual antiplatelet therapy.

Endoscopic sphincterotomy combined with large balloon dilation for bile duct stones

Objective To evaluate the therapeutic efficacy and safety of endoscopic sphincterotomy （EST） combined with large balloon dilation for bile duct stones. Methods A total of 83 patients with com- mon bile duct stones were randomly divided into 2 groups to receive standard EST （n = 41, EST group） or EST plus large balloon dilation （ n = 42, EPLBD group） , respectively. The number of endoscopic session, operation time, rates of successful complete stone retrieval, mechanical lithotripsy, and procedure related complication were compared between the two groups. Results The rate of early procedure-related complica- tions was similar in 2 groups （9/41 vs. 7/42, P 〉 0. 05 ）, including perforation （ 1/41 vs. 0/42, P 〉 0. 05 ）, bleeding （5/41 vs. 2/42, P 〉0. 05） and pancreatitis （3/41 vs. 5/42, P 〉0. 05）. The rate of suc- cessful complete stone removal was also similar in 2 groups （39/41 vs. 41/42, P 〉 0. 05）. However, EST group needed more procedure time （38. 8 ± 4. 3 min vs. 29.2 ± 5.3 rain, P 〈 0. 01 ） and use of mechanical lithotripsy to achieve complete stone removal （9/41 vs. 2/42, P 〈 0. 05 ）. Only one patient in EPLBD group （ 1/42, 2.4% ） needed a second ERCP to clear bile duct stone, while in EST group, 8 patients underwent a second procedure （ 19. 5% , P 〈 0. 05）. Conclusion For endoscopic removal of common bile duct stones, EST combined with large balloon dilation is as safe and effective as EST, while easier in manipulation. Key words: Common bile duct calculi; Sphincterotomy; Endoscopic; Balloon dilatation

Endoscopic Sphincterotomy plus Large-Balloon Dilation for Removal of Bile Duct Stones

Recent studies have suggested that large-balloon dilation (LBD; 12–20 mm) of the biliary orifice after sphincterotomy is an effective method for removing bile-duct stones that cannot be extracted by standard endoscopic sphincterotomy (EST) and a retrieval balloon or basket. To determine the efficacy and safety of EST and LBD, researchers in Korea compared EST plus LBD to EST alone in 200 consecutive patients with …

The safety of endoscopic sphincterotomy in patients receiving antiplatelet agents – a case–control study

To determine whether antiplatelet agents are associated with endoscopic sphincterotomy-related haemorrhage as few well-controlled data exist on this controversial issue. A case-control study in a tertiary care setting included cases with bleeding following endoscopic sphincterotomy, matched with 2-3 controls selected according to age +/- 15 years, sex, and procedural date+/- 2 years. Cases and controls were compared for possible risk factors of postendoscopic sphincterotomy bleeding (presence of a coagulopathy and cholangitis). The main outcome measurement was the association between the use of antiplatelet medications and postendoscopic sphincterotomy bleeding after adjustment for possible confounding. The 40 cases [mean age 68 +/- 17 (s.d.) years, 50% female] and 86 controls [68 +/- 16 years, 50% female] were comparable except for differences noted in International Normalized Ratio (INR) (>2 in four cases vs. two controls), and pre-endoscopic sphincterotomy cholangitis (45% vs. 20%). Amongst cases, 13% were on aspirin and 3% on clopidogrel; 17% of controls took aspirin, and 4% a non-steroidal anti-inflammatory drug. 53% of cases bled immediately; the remainder haemorrhaged at 2 +/- 3 days. After adjustment for an elevated INR and cholangitis, exposure to antiplatelet agents was not significantly associated with procedure-related bleeding (odds ratio = 0.41, 95% CI [ 0.13; 1.31]). This case-control study provides controlled data suggesting that antiplatelet agents do not significantly increase the risk of clinically-important bleeding related to endoscopic sphincterotomy. The low prevalences of non-steroidal anti-inflammatory drugs and clopidogrel use limit any definite conclusion on their elective use before endoscopic sphincterotomy.

Safety of Endoscopic Sphincterotomy in Patients with Periampullary Diverticulum

Background: Periampullary duodenal diverticula (PAD) are generally an incidental finding in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). There is uncertainty about the increased risk of complications especially with endoscopic sphincterotomy (ES).

Endoscopic management of bile duct stones.

The advantages of endoscopic retrograde cholangiopancreatography (ERCP) over open surgery make it the predominant method of treating choledocholithiasis. Today, technologic advances such as magnetic resonance cholangiopancreatography and laparoscopic surgery are challenging ERCP's primacy in the management of common bile duct (CBD) stones. This article reviews the current status of endoscopic treatment of biliary stones and examines this in relation to laparoscopic management. The techniques and safety of endoscopic sphincterotomy and balloon sphincteroplasty are reviewed. Balloon sphincteroplasty should be limited to study protocols because of safety questions and inherent limitations. After sphincterotomy, 85% to 90% of CBD stones can be removed with a Dormia basket or balloon catheter. These techniques are described as having both advantages and disadvantages. Methods for managing "difficult stones" include mechanical lithotripsy, intraductal shock wave lithotripsy, extracorporeal shock wave lithotripsy, chemical dissolution, and biliary stenting. These approaches are presented along with data supporting their use in specific situations. Laparoscopic cholecystectomy has emerged as the preferred alternative to open cholecystectomy. Parallel advances in the endoscopic and laparoscopic management of CBD stones have made the issue regarding the optimal treatment strategy complex. Three approaches to the management of choledocholithiasis in the laparoscopic era are presented as follows: strict therapeutic splitting, flexible therapeutic splitting, and strict laparoscopic management. The optimal approach needs to be defined in prospective comparative trials. For now, preoperative endoscopic stone extraction should still be recommended as the approach of choice in patients suspected to have CBD stones based on clinical, biochemical, and imaging parameters. Primary laparoscopic evaluation and management is reasonable in patients who have a low-to-moderate probability of having CBD stones.