Randomized trial of endoscopic sphincterotomy with balloon dilation versus endoscopic sphincterotomy alone for removal of bile duct stones.

BACKGROUND & AIMS: Limited endoscopic sphincterotomy with large balloon dilation (ESBD) is an alternative to endoscopic sphincterotomy (ES) for removing bile duct stones, but it is not clear which procedure is most effective. We compared the 2 techniques in removal of bile duct stones. METHODS: Between September 2005 and September 2011, 156 consecutive patients with suspected of having, or known to have, common bile duct stones were randomly assigned to groups that underwent ES or ESBD. Patients in the ESBD group underwent limited sphincterotomy (up to half of the sphincter) followed by balloon dilation to the size of the common bile duct or 15 mm, and patients in the ES group underwent complete sphincterotomy alone. Stones were then removed using standard techniques. The primary outcome was percentage of stones cleared, and secondary outcomes included procedural time, method of stone extraction, number of procedures required for stone clearance, morbidities and mortality within 30 days, and direct cost. RESULTS: There was no significant difference between groups in percentage of stones cleared (ES vs ESBD: 88.5% vs 89.0%). More patients in the ES group (46.2%) than the ESBD group (28.8%) required mechanical lithotripsy (P = .028), particularly for stones ≥15 mm (90.9% vs 58.1%; P = .002). Morbidities developed in 10.3% of patients in the ES group and 6.8% of patients in the ESBD group (P = .46). The cost of the hospitalization was also significantly lower in the ESBD group (P = .034). CONCLUSIONS: ESBD and ES clear bile stones with equal efficacy. However, ESBD reduces the need for mechanical lithotripsy and is less expensive; ClinicalTrials.gov number, NCT00164853.

Endotherapy versus surgery for early neoplasia in Barrett's esophagus: a meta-analysis.

BACKGROUND: Esophagectomy is the conventional treatment for Barrett's esophagus with high-grade dysplasia and intramucosal cancer. Endotherapy is an alternative treatment. OBJECTIVE: To compare the efficacy and safety of these 2 treatments. DESIGN: PubMed, Web of Science, EMBASE, Cochrane Library and momentous meeting abstracts were searched. Studies comparing endotherapy with esophagectomy were included in the meta-analysis. Pooling was conducted in a random-effects model. SETTING: Tertiary-care facility. PATIENTS: Seven studies involving 870 patients were included. INTERVENTION: Endotherapy and esophagectomy. MAIN OUTCOME MEASUREMENTS: Neoplasia remission rate, neoplasia recurrence rate, overall survival rate, neoplasia-related death, and major adverse events. RESULTS: Meta-analysis showed that there was no significant difference between endotherapy and esophagectomy in the neoplasia remission rate (relative risk [RR] 0.96; 95% CI, 0.91-1.01); overall survival rate at 1 year (RR 0.99; 95% CI, 0.94-1.03), 3 years (RR 1.03; 95% CI, 0.96-1.10), and 5 years (RR 1.00; 95% CI, 0.93-1.06); and neoplasia-related mortality (risk difference [RD] 0; 95% CI, -0.02 to 0.01). Endotherapy was associated with a higher neoplasia recurrence rate (RR 9.50; 95% CI, 3.26-27.75) and fewer major adverse events (RR 0.38; 95% CI, 0.20-0.73). LIMITATIONS: Relatively small number of retrospective studies available, different types of endoscopic treatments were used. CONCLUSION: Endotherapy and esophagectomy show similar efficacy except in the neoplasia recurrence rate, which is higher after endotherapy. Prospective, randomized, controlled trials are needed to confirm these results.

Antireflux stents to reduce the risk of cholangitis in patients with malignant biliary strictures: a randomized trial.

BACKGROUND AND STUDY AIMS: There are limited data on the role of antireflux biliary stents. This single-center randomized trial compared the endoscopic use of partly covered antireflux metal stents (pcARMS) with that of standard uncovered self-expandable metal stents (ucSEMS) for the palliation of nonhilar malignant biliary obstruction. PATIENTS AND METHODS: Between August 2007 and February 2012, patients with nonhilar malignant biliary obstruction were randomly assigned to treatment with either pcARMS or ucSEMS. Subsequent follow-up was conducted in clinic or by phone. The primary outcome was onset of cholangitis within 12 months of stenting. Secondary outcomes included other morbidities, stent dysfunctions, and survival. RESULTS: Altogether 112 patients were included, 56 in each group. The stents were successfully deployed in all patients. Satisfactory jaundice control was achieved in 49 cases in the pcARMS group, compared with 47 in the ucSEMS group (P = 0.135). Fewer patients experienced cholangitis in the pcARMS group than in the ucSEMS group (10 vs. 21 patients; P = 0.035), and the frequency of episodes was less (P = 0.022). Respectively, 17 and 29 stent dysfunctions before death were observed in the pcARMS and ucSEMS groups (P = 0.051) and the median stent patency was 13.0 (standard deviation [SD] 3.4) and 10.0 (1.2) months, respectively (P = 0.044). At final follow-up, in January 2013, 50 /52 and 52 /55 patients had died and no difference in median survival was seen between the two groups (8.0 vs. 9.0 months, P = 0.56). CONCLUSIONS: Stenting with pcARMS compared with standard ucSEMS reduces risk of ascending cholangitis and has longer stent patency, but does not increase patient survival. Chictr.org. number, ChiCTR-TRC-11001800.

Covered versus uncovered self-expandable metallic stents for palliation of malignant gastric outlet obstruction: a systematic review and meta-analysis.

BACKGROUND: Self-expandable metallic stents (SEMSs) are widely used for palliation of malignant gastric outlet obstruction (GOO). There are two types of SEMS, covered and uncovered, each with its own advantages and disadvantages. We aimed to compare the efficacy and safety between uncovered and covered SEMSs in the palliation of malignant gastric outlet obstruction. METHODS: Databases including PubMed, EMBASE, the Cochrane Library, the Science Citation Index and momentous meeting abstracts were searched and evaluated by two reviewers independently. RESULTS: Nine trials involving 849 patients were analyzed. Meta-analysis showed there was no significant difference in technical success rate (RR 1.0, 95% CI [0.98, 1.01]), clinical success rate (RR 1.04, 95% CI [0.98, 1.11]), post-stenting dysphagia score (WMD -0.01, 95% CI [-0.52, 0.50]), stent patency (WMD -0.31, 95% CI [-1.73, 1.11]), overall complications (RR 1.07, 95% CI [0.87, 1.32]) and reintervention rate (RR 1.30, 95% CI [0.92, 1.83]) between covered and uncovered SEMSs group. However, covered SEMSs were associated with higher migration rate (RR 3.48, 95% CI [2.16, 5.62], P < 0.00001) and lower obstruction rate (RR 0.42, 95% CI [0.24, 0.73], P = 0.002). CONCLUSIONS: In the palliative treatment of malignant gastric outlet obstruction, both covered and uncovered SEMSs are safely and effective. Covered stents can reduce the risk of restenosis, whereas uncovered stents are effective in decreasing stent migration.

Feasibility of using wire-guided needle-knife electrocautery for refractory biliary and pancreatic strictures.

BACKGROUND: Endoscopic management of biliary or pancreatic strictures by stent insertion is well established. However, some high-grade strictures are refractory to dilation and stent placement with conventional methods. OBJECTIVE: To evaluate the safety and efficacy of the wire-guided electrotomy technique in dilating stiff biliary and/or pancreatic stenoses when ordinary methods failed. DESIGN: Retrospective analysis of a prospective database. SETTING: Tertiary referral university hospital. PATIENTS: This study involved 279 patients with biliary or pancreatic strictures who underwent ERCP for stenting. INTERVENTION: After conventional dilation failed, wire-guided needle-knife electrocautery was attempted to facilitate insertion of the dilating devices and eventually endoprosthesis. MAIN OUTCOME MEASUREMENTS: The successful treatment and drainage of biliary or pancreatic strictures. RESULTS: With wire-guided needle-knife cauterization, the success rate of stricture dilatation increased from 95.7% (267 of 279 patients) to 98.9% (276 of 279 patients). Dilation of stenoses was successful in 9 of 10 patients (90%) by using electrocautery with the wire-guided needle-knife technique. Postprocedure adverse events included self-limited bleeding, mild acute pancreatitis, hyperamylasemia, cholangitis, and biliary perforation. No procedure-related death occurred. LIMITATIONS: Retrospective, single-center study and small sample size. CONCLUSIONS: Wire-guided needle-knife electroincision appears to be effective for traversing refractory biliary or pancreatic strictures and can be considered as an alternative approach to conventional methods. However, the safety of such a technique needs to be further evaluated.

A novel antireflux metal stent for the palliation of biliary malignancies: a pilot feasibility study (with video).

BACKGROUND: Antireflux stents that prevent duodenal biliary reflux may improve biliary drainage and prolong stent patency. However, the use of antireflux metal stents (ARMSs) in the human biliary system has not been reported. OBJECTIVE: To evaluate the safety and efficacy of ARMSs for the palliation of unresectable distal biliary malignancies. DESIGN AND SETTING: A retrospective case series in a tertiary referral center. PATIENTS: From August 2007 to April 2009, a total of 23 patients with unresectable nonhilar malignant biliary obstruction. INTERVENTION: Endoscopic placement of an ARMS. MAIN OUTCOME MEASUREMENTS: Technical success and early complications with follow-up of stent patency and patient survival. RESULTS: Placement of an ARMS was successful on the first attempt in all patients. There were no procedure-related complications. Follow-up was obtained in 22 cases. Serum bilirubin level returned to normal within 1 month of stenting in 20 patients. Six stent malfunctions occurred as a result of tumor ingrowth (1 patient), tumor overgrowth (2 patients), and stent migration (3 patients). The remaining patients were free of biliary symptoms until death or final follow-up. The median duration of stent patency of ARMSs was 14 months, with cumulative patency rates at 3, 6, and 12 months of 95%, 74%, and 56%, respectively. The median survival of the patients was 7.9 months (range, 1-14 months). LIMITATIONS: Small number of patients in single endoscopy center. CONCLUSIONS: Endoscopic insertion of an ARMS is technically feasible, safe, and effective in patients with distal malignant biliary obstruction. The impact of ARMSs in prolonging stent patency and life expectancy deserves further randomized evaluation.

Endoscopic drainage for duodenal hematoma following endoscopic retrograde cholangiopancreatography: a case report.

Intramural duodenal hematoma (IDH) is a rare complication following endoscopic retrograde cholangiopancreatography (ERCP). Blunt damage caused by the endoscope or an accessory has been suggested as the main reason for IDH. Surgical treatment of isolated duodenal hematoma after blunt trauma is traditionally reserved for rare cases of perforation or persistent symptoms despite conservative management. Typical clinical symptoms of IDH include abdominal pain and vomiting. Diagnosis of IDH can be confirmed by imaging techniques, such as magnetic resonance imaging or computed tomography and upper gastrointestinal endoscopy. Duodenal hematoma is mainly treated by drainage, which includes open surgery drainage and percutaneous transhepatic cholangial drainage, both causing great trauma. Here we present a case of massive IDH following ERCP, which was successfully managed by minimally invasive management: intranasal hematoma aspiration combined with needle knife opening under a duodenoscope.

Endoscopic papillary large-balloon dilation following limited sphincterotomy for the removal of refractory bile duct stones: experience of 169 cases in a single Chinese center.

OBJECTIVE: To evaluate the efficacy and safety of endoscopic papillary large-balloon dilation (EPLBD) combined with limited endoscopic sphincterotomy (EST) for the removal of large biliary duct stones (≥10 mm). METHODS: Data of patients who underwent an attempted removal of large bile duct stones by limited EST followed by EPLBD (≥12 mm in diameter) from April 2006 to October 2011 in our center were reviewed. Clinical characteristics, endoscopic methods and outcomes of the patients were collected and analyzed. RESULTS: A total of 169 patients with a mean age of 69.3 years (range 19-97 years) underwent 171 procedures. Median stone size and balloon diameter was 15 mm and 13 mm, respectively. Complete stone removal in a single session was achieved in 163 procedures (95.3%) with mechanical lithotripsy (ML) used in 66 (38.6%). Patients with a larger stone size required more frequent use of ML with a comparable success rate (P < 0.01). There were no significant differences between patients with and without periampullary diverticula in stone clearance (97.3% vs 93.8%), ML requirement (36.5% vs 40.2%) and complications (2.7% vs 6.2%) (all P > 0.05). Seven patients had eight procedure-related complications including moderate or mild bleeding (n = 4), minor perforation (n = 1), mild pancreatitis (n = 2) and cholangitis (n = 1). CONCLUSION: EPLBD following limited EST is an effective and safe approach for the removal of large biliary duct stones, especially for those refractory cases.

Endoscopic stenting for post-transplant biliary stricture: usefulness of a novel removable covered metal stent.

BACKGROUND: Endoscopic management of biliary anastomotic stricture (AS) following liver transplantation (LT) remains challenging. There are no dedicated self-expandable metal stents (SEMS) for this setting. METHODS: A short fully covered SEMS (FCSEMS) with a retrieval suture was designed. Between July 2008 and June 2010, 13 patients with post-LT AS had this FCSEMS placed endoscopically, keeping the whole stent inside the bile duct across the AS with the retriever out of the papilla. The stents were removed by forceps under endoscopy according to a schedule. Technical success, complications, AS resolution and the outcome for the patients were observed. RESULTS: Placement of the FCSEMS was successful on the first attempt in all patients. One patient with complicated infection did not respond to the stenting therapy and underwent stent retrieval ahead of schedule. Others kept well during stenting for a mean (SD) duration of 5.4 (1.7) months (range 2-8) without stent migration. All stents were removed successfully without great difficulty. AS resolution was obtained in all 12 patients, who were closely followed up for a mean (SD) time of 12.1 (8.0) months (range 1-26.5) after stent removal. Stricture recurrence occurred in one, who underwent a successful re-intervention with a second FCSEMS. Others remain free from symptoms and have normal liver function up to now. CONCLUSIONS: Endoscopic treatment of post-LT AS using a removable FCSEMS is technically feasible, safe, and effective. This dedicated method may play an increasing role in the future management of benign biliary strictures.