PMID- 31041366
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2364-3722 (Print)
IS  - 2196-9736 (Electronic)
IS  - 2196-9736 (Linking)
VI  - 7
IP  - 4
DP  - 2019 Apr
TI  - Safety, efficacy, and removability of a fully covered multi-hole metal stent in a 
      swine model of hilar biliary stricture: a feasibility study.
PG  - E498-E503
LID - 10.1055/a-0846-0775 [doi]
AB  - Background and study aims  Use of fully covered self-expandable metal stents 
      (FCSEMS) for biliary drainage of malignant hilar biliary strictures is limited 
      because of risk of cholangitis due to side branch obstruction. The aim of this 
      study was to evaluate the safety and efficacy of unilateral placement of a 
      multi-hole FCSEMS (FCSEMS-MH), which had a 2.5-mm hole in the center of the 
      membrane on each cavity, in a swine model of hilar biliary stricture. Materials 
      and methods  Six female mini pigs were included in this prospective study. The 
      hilar biliary stricture model was prepared using an endobiliary radiofrequency 
      ablation. FCSEMS-MHs were endoscopically inserted into the peri-hilar bile duct 
      of all the animals. Outcomes were assessed in terms of adverse events (AEs) 
      including cholangitis, stent patency, stent migration, and endoscopic stent 
      removability for 1 month after stenting. Results  In terms of hilar biliary 
      stricture types, two animals were of Bismuth type I and four were of type II. 
      Technical success rate for endoscopic metal stenting was 100 % (6/6), and the 
      functional success rate, which was evaluated 7 days after stent insertion, was 
      also 100 % (5/5). The immediate overall AE rate was 0 %. There was no 
      procedure-related mortality and stent migration did not occur in any animal 
      during the 4-week stent indwelling period. Stents were removed from all six 
      animals at 4 weeks post-stenting. Conclusion  Unilateral placement of FCSEMS-MH 
      might be safe and effect for swine hilar biliary stricture models. However, 
      long-term follow-up and comparative studies are needed to verify the usefulness 
      of this stent.
FAU - Park, Jin-Seok
AU  - Park JS
AD  - Digestive Disease Center, Department of Internal Medicine, Inha University School 
      of Medicine, Incheon, Republic of Korea.
AD  - National Center of Efficacy Evaluation for the Development of Health Products 
      Targeting Digestive Disorders (NCEED), Incheon, Republic of Korea.
FAU - Jeong, Seok
AU  - Jeong S
AD  - Digestive Disease Center, Department of Internal Medicine, Inha University School 
      of Medicine, Incheon, Republic of Korea.
AD  - National Center of Efficacy Evaluation for the Development of Health Products 
      Targeting Digestive Disorders (NCEED), Incheon, Republic of Korea.
FAU - Kobayashi, Makoto
AU  - Kobayashi M
AD  - Department of Gastroenterology, Yokkaichi Municipal Hospital, Yokkaichi, Japan.
FAU - Lee, Don Haeng
AU  - Lee DH
AD  - Digestive Disease Center, Department of Internal Medicine, Inha University School 
      of Medicine, Incheon, Republic of Korea.
AD  - National Center of Efficacy Evaluation for the Development of Health Products 
      Targeting Digestive Disorders (NCEED), Incheon, Republic of Korea.
AD  - Utah-Inha DDS & Advanced Therapeutics Research Center, Incheon, Republic of 
      Korea.
LA  - eng
PT  - Journal Article
DEP - 20190403
PL  - Germany
TA  - Endosc Int Open
JT  - Endoscopy international open
JID - 101639919
PMC - PMC6447406
COIS- Competing interests None
EDAT- 2019/05/02 06:00
MHDA- 2019/05/02 06:01
PMCR- 2019/04/01
CRDT- 2019/05/02 06:00
PHST- 2018/07/05 00:00 [received]
PHST- 2018/10/08 00:00 [accepted]
PHST- 2019/05/02 06:00 [entrez]
PHST- 2019/05/02 06:00 [pubmed]
PHST- 2019/05/02 06:01 [medline]
PHST- 2019/04/01 00:00 [pmc-release]
AID - 10.1055/a-0846-0775 [doi]
PST - ppublish
SO  - Endosc Int Open. 2019 Apr;7(4):E498-E503. doi: 10.1055/a-0846-0775. Epub 2019 Apr 
      3.