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Novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study

Background and study aims  We developed a self-expandable metallic stent (SEMS) with a distal tapered end to reproduce the physiological bile flow with a pressure gradient due to the difference in the diameter. We aimed to evaluate the safety and efficacy of the newly developed distal tapered covere...

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Autores principales: Doi, Shinpei, Namura, Yuta, Kikuyama, Tomohiro, Saito, Go, Adachi, Takako, Matsumoto, Kotaro, Watanabe, Ayako, Tsunashima, Hiromichi, Katsukura, Nobuhiro, Tsujikawa, Takayuki, Yasuda, Ichiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Georg Thieme Verlag KG 2023
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10169231/
https://www.ncbi.nlm.nih.gov/pubmed/37180308
http://dx.doi.org/10.1055/a-2039-3853
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author Doi, Shinpei
Namura, Yuta
Kikuyama, Tomohiro
Saito, Go
Adachi, Takako
Matsumoto, Kotaro
Watanabe, Ayako
Tsunashima, Hiromichi
Katsukura, Nobuhiro
Tsujikawa, Takayuki
Yasuda, Ichiro
author_facet Doi, Shinpei
Namura, Yuta
Kikuyama, Tomohiro
Saito, Go
Adachi, Takako
Matsumoto, Kotaro
Watanabe, Ayako
Tsunashima, Hiromichi
Katsukura, Nobuhiro
Tsujikawa, Takayuki
Yasuda, Ichiro
author_sort Doi, Shinpei
collection PubMed
description Background and study aims  We developed a self-expandable metallic stent (SEMS) with a distal tapered end to reproduce the physiological bile flow with a pressure gradient due to the difference in the diameter. We aimed to evaluate the safety and efficacy of the newly developed distal tapered covered metal stent (TMS) for distal malignant biliary obstruction (DMBO). Patients and methods  This single-center, prospective, single-arm study was conducted in patients with DMBO. The primary endpoint was time to recurrent biliary obstruction (TRBO), and the secondary endpoints were the survival time and incidence of adverse events (AEs). Results  Thirty-five patients (15 men, 20 women; median age, 81 years [range: 53–92]) were enrolled between December 2017 and December 2019. The primary diseases were pancreatic head cancer in 25 cases, bile duct cancer in eight cases, and ampullary cancer in two cases. TMS was successfully placed in all cases. Acute cholecystitis occurred as an early AE (within 30 days) in two cases (5.7 %). The median TRBO was 503 days, median survival time was 239 days. RBO was observed in 10 cases (28.6 %), and the causes were distal migration in six cases, proximal migration in two cases, biliary sludge in one case, and tumor overgrowth in one case. Conclusions  Endoscopic placement of the newly developed TMS in patients with DMBO is technically feasible and safe, and the TRBO was remarkably long. The anti-reflux mechanism based on the difference in diameter may be effective, and a randomized controlled trial with a conventional SEMS is required.
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spelling pubmed-101692312023-05-10 Novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study Doi, Shinpei Namura, Yuta Kikuyama, Tomohiro Saito, Go Adachi, Takako Matsumoto, Kotaro Watanabe, Ayako Tsunashima, Hiromichi Katsukura, Nobuhiro Tsujikawa, Takayuki Yasuda, Ichiro Endosc Int Open Background and study aims  We developed a self-expandable metallic stent (SEMS) with a distal tapered end to reproduce the physiological bile flow with a pressure gradient due to the difference in the diameter. We aimed to evaluate the safety and efficacy of the newly developed distal tapered covered metal stent (TMS) for distal malignant biliary obstruction (DMBO). Patients and methods  This single-center, prospective, single-arm study was conducted in patients with DMBO. The primary endpoint was time to recurrent biliary obstruction (TRBO), and the secondary endpoints were the survival time and incidence of adverse events (AEs). Results  Thirty-five patients (15 men, 20 women; median age, 81 years [range: 53–92]) were enrolled between December 2017 and December 2019. The primary diseases were pancreatic head cancer in 25 cases, bile duct cancer in eight cases, and ampullary cancer in two cases. TMS was successfully placed in all cases. Acute cholecystitis occurred as an early AE (within 30 days) in two cases (5.7 %). The median TRBO was 503 days, median survival time was 239 days. RBO was observed in 10 cases (28.6 %), and the causes were distal migration in six cases, proximal migration in two cases, biliary sludge in one case, and tumor overgrowth in one case. Conclusions  Endoscopic placement of the newly developed TMS in patients with DMBO is technically feasible and safe, and the TRBO was remarkably long. The anti-reflux mechanism based on the difference in diameter may be effective, and a randomized controlled trial with a conventional SEMS is required. Georg Thieme Verlag KG 2023-05-09 /pmc/articles/PMC10169231/ /pubmed/37180308 http://dx.doi.org/10.1055/a-2039-3853 Text en The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited.
spellingShingle Doi, Shinpei
Namura, Yuta
Kikuyama, Tomohiro
Saito, Go
Adachi, Takako
Matsumoto, Kotaro
Watanabe, Ayako
Tsunashima, Hiromichi
Katsukura, Nobuhiro
Tsujikawa, Takayuki
Yasuda, Ichiro
Novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study
title Novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study
title_full Novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study
title_fullStr Novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study
title_full_unstemmed Novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study
title_short Novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study
title_sort novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10169231/
https://www.ncbi.nlm.nih.gov/pubmed/37180308
http://dx.doi.org/10.1055/a-2039-3853
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