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.


METHODS
A retrospective case series in a tertiary referral center.


METHODS
From August 2007 to April 2009, a total of 23 patients with unresectable nonhilar malignant biliary obstruction.


METHODS
Endoscopic placement of an ARMS.


METHODS
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).


CONCLUSIONS
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.
Hu
Bing
B
Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University, Shanghai, China.
Wang
Tian-Tian
TT
Shi
Zhi-Mei
ZM
Wang
Shu-Zhi
SZ
Lu
Rui
R
Pan
Ya-Min
YM
Huang
Hui
H
Wang
Shu-Ping
SP
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001661:Biliary Tract Neoplasms / Q000150:complications / Q000401:mortality / Q000601:surgery*; D002779:Cholestasis / Q000209:etiology / Q000601:surgery*; D018450:Disease Progression; D005240:Feasibility Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010166:Palliative Care / Q000379:methods*; D010865:Pilot Projects; D011475:Prosthesis Failure; D012189:Retrospective Studies; D015607:Stents