Endoscopic radiofrequency ablation may improve overall survival in patients with inoperable ampullary carcinoma.

OBJECTIVES: Patients with advanced ampullary carcinoma (AC) who are unsuitable for surgery are most likely to have poor outcomes. The role of endoscopic radiofrequency ablation (RFA) in this population has not been fully defined. We aimed to assess the short- and long-term outcomes of RFA in a large cohort of AC patients. METHODS: In this retrospective study, data of consecutive patients with pathologically proven AC who underwent successful endobiliary RFA and/or stent placement were collected. All patients did not undergo surgical resection. The primary outcome was overall survival (OS). The secondary outcomes included clinical success and adverse events. RESULTS: A total of 85 patients, 50 in the RFA plus stenting group and 35 in the stenting alone group, were identified. The median OS was significantly longer in the RFA group than in the stenting alone group (16.9 vs. 9.8 months, P < 0.001). In multivariable Cox analysis, RFA (hazards ratio 0.408; 95% confidence interval 0.235-0.706; P = 0.001) was the only independent OS predictor. Eight patients with stage II tumors, exclusively from the RFA group, survived for more than 3 years. Clinical success was comparable between the two groups (96% vs. 100%, P = 0.231). Early adverse events between the two groups were similar (10% vs. 2.9%, P = 0.206); however, late biliary/pancreatic stenoses occurred in three RFA patients who were successfully managed with endoscopic interventions. CONCLUSIONS: Endoscopic RFA appears to prolong patients' survival with acceptable safety; it may therefore be a feasible treatment option for patients with inoperable ampullary cancers.

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.

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.