PMID- 37180308
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230920
IS  - 2364-3722 (Print)
IS  - 2196-9736 (Electronic)
IS  - 2196-9736 (Linking)
VI  - 11
IP  - 5
DP  - 2023 May
TI  - Novel anti-reflux biliary metal stent with a distal tapered end for distal 
      malignant biliary obstruction: a feasibility study.
PG  - E460-E465
LID - 10.1055/a-2039-3853 [doi]
AB  - 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.
CI  - 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/).
FAU - Doi, Shinpei
AU  - Doi S
AD  - Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa 
      Japan.
FAU - Namura, Yuta
AU  - Namura Y
AD  - Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa 
      Japan.
FAU - Kikuyama, Tomohiro
AU  - Kikuyama T
AD  - Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa 
      Japan.
FAU - Saito, Go
AU  - Saito G
AD  - Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa 
      Japan.
FAU - Adachi, Takako
AU  - Adachi T
AD  - Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa 
      Japan.
FAU - Matsumoto, Kotaro
AU  - Matsumoto K
AD  - Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa 
      Japan.
FAU - Watanabe, Ayako
AU  - Watanabe A
AD  - Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa 
      Japan.
FAU - Tsunashima, Hiromichi
AU  - Tsunashima H
AD  - Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa 
      Japan.
FAU - Katsukura, Nobuhiro
AU  - Katsukura N
AD  - Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa 
      Japan.
FAU - Tsujikawa, Takayuki
AU  - Tsujikawa T
AD  - Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa 
      Japan.
FAU - Yasuda, Ichiro
AU  - Yasuda I
AD  - Third Department of Internal Medicine, University of Toyama, Toyama, Japan.
LA  - eng
PT  - Journal Article
DEP - 20230509
PL  - Germany
TA  - Endosc Int Open
JT  - Endoscopy international open
JID - 101639919
PMC - PMC10169231
COIS- Competing interests The authors declare that they have no conflict of interest.
EDAT- 2023/05/14 19:13
MHDA- 2023/05/14 19:14
PMCR- 2023/05/01
CRDT- 2023/05/14 12:03
PHST- 2022/07/07 00:00 [received]
PHST- 2023/02/15 00:00 [accepted]
PHST- 2023/05/14 19:13 [pubmed]
PHST- 2023/05/14 19:14 [medline]
PHST- 2023/05/14 12:03 [entrez]
PHST- 2023/05/01 00:00 [pmc-release]
AID - 10.1055/a-2039-3853 [doi]
PST - epublish
SO  - Endosc Int Open. 2023 May 9;11(5):E460-E465. doi: 10.1055/a-2039-3853. 
      eCollection 2023 May.