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. 2020 Jun 10;20(1):184.
doi: 10.1186/s12876-020-01325-9.

A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study

Christopher Lawrence  1 , Jose Nieto  2 , Willis G Parsons  3 , André Roy  4 , Nalini M Guda  5 , Stephen E Steinberg  6 , Muhammad K Hasan  7 , Juan Carlos Bucobo  8 , Satish Nagula  8 , Nicholas D Dey  9 , Jonathan M Buscaglia  10 ; Study Investigators
Affiliations

A newly designed uncovered biliary stent for palliation of malignant obstruction: results of a prospective study

Christopher Lawrence et al. BMC Gastroenterol. .

Abstract

Background: Biliary decompression can reduce symptoms and improve quality of life in patients with malignant biliary obstruction. Endoscopically placed stents have become the standard of care for biliary drainage with the aim of improving hepatic function, relieving jaundice, and reducing adverse effects of obstruction. The purpose of this study was to evaluate the performance characteristics of a newly-designed, uncovered metal biliary stent for the palliation of malignant biliary obstruction.

Methods: This post-market, prospective study included patients with biliary obstruction due to a malignant neoplasm treated with a single-type, commercially available uncovered self-expanding metal stent (SEMS). Stents were placed as clinically indicated for palliation of jaundice and to potentially facilitate neo-adjuvant chemotherapy. The main outcome measure was freedom from recurrent biliary obstruction (within the stent) requiring re-intervention within 1, 3, and 6 months of stent insertion. Secondary outcome measures included device-related adverse events and technical success of stent deployment.

Results: SEMS were placed in 113 patients (73 men; mean age, 69); a single stent was inserted in 106 patients, and 2 stents were placed in 7 patients. Forty-eight patients survived and/or completed the 6 month study protocol. Freedom from symptomatic recurrent biliary obstruction requiring re-intervention was achieved in 108 of 113 patients (95.6, 95%CI = 90.0-98.6%) at study exit for each patient. Per interval analysis yielded the absence of recurrent biliary obstruction in 99.0% of patients at 1 month (n = 99; 95%CI = 97.0-100%), 96.6% of patients at 3 months (n = 77; 95%CI = 92.7-100%), and 93.3% of patients at 6 months (n = 48; 95%CI = 86.8-99.9%). In total, only 5 patients (4.4%) were considered failures of the primary endpoint. Most of these failures (4/5) were due to stent occlusion from tumor ingrowth or overgrowth. Overall technical success rate of stent deployment was 99.2%. There were 2 cases of stent-related adverse events (1.8%). There were no cases of post-procedure stent migration, stent-related perforation, or stent-related deaths.

Conclusions: This newly designed and marketed biliary SEMS system appears to be effective at relieving biliary obstruction and preventing re-intervention within 6 months of insertion in the overwhelming majority of patients. The device has an excellent safety profile, and associated high technical success rate during deployment.

Trial registration: The study was registered on clinicaltrials.gov on 14 October 2013 and the study registration number is NCT01962168. University of Massachusetts Medical School did not participate in the study.

Keywords: Biliary tract neoplasms; Palliative medicine; Prosthesis design; Self expandable metallic stent; Stents.

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Conflict of interest statement

Author J.M.B. is a speaker for AbbVie and Boston Scientific, author W.G.P. is a consultant for Cook Medical and Medtronic, author N.M.G. is a consultant for Boston Scientific, author M.K.H. is a consultant for Boston Scientific, J.C.B. is a consultant for Boston Scientific, and author N.D.D. is a paid employee of Cook Research Incorporated., a contract research organization and Cook Group Company. Authors J.N., A.R., S.E.S., S.N., and C.L. declare no conflicts of interests for this article.

Figures

Fig. 1
Fig. 1
The Evolution® Biliary Stent System – Uncovered. Image provided with written permission for use from Cook Medical Inc.
Fig. 2
Fig. 2
Patient flowchart of enrollment, retention, and clinical follow-up
Fig. 3
Fig. 3
Clinical Success - Freedom from symptomatic recurrent biliary obstruction (within the stent) requiring re-intervention
See this image and copyright information in PMC

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