PMID- 28302527
OWN - NLM
STAT- MEDLINE
DCOM- 20180727
LR  - 20220409
IS  - 1097-6779 (Electronic)
IS  - 0016-5107 (Linking)
VI  - 86
IP  - 6
DP  - 2017 Dec
TI  - Multiple plastic stents versus covered metal stent for treatment of anastomotic 
      biliary strictures after liver transplantation: a prospective, randomized, 
      multicenter trial.
PG  - 1038-1045
LID - S0016-5107(17)30189-X [pii]
LID - 10.1016/j.gie.2017.03.009 [doi]
AB  - BACKGROUND AND AIMS: Treatment of anastomotic biliary strictures (ABSs) after 
      orthotopic liver transplantation by endoscopic insertion of multiple plastic 
      stents (MPSs) is well established. The use of covered self-expandable metal 
      stents (cSEMSs) for this indication is less investigated. METHODS: In an 
      open-label, multicenter, randomized trial, patients with confirmed ABSs were 
      randomly assigned 1:1 to receive either an MPS or a cSEMS. The primary endpoint 
      was the number of endoscopic interventions until ABS resolution. Secondary 
      endpoints were frequency of adverse events, treatment success rates, and time to 
      treatment success and recurrence of ABS during follow-up of at least 1 year. 
      RESULTS: Fifty-eight patients were included between 2012 and 2015, and 48 
      patients completed follow-up. Patients receiving MPS (n = 24) underwent a median 
      of 4 (range, 3-12) endoscopic retrograde cholangiography examinations, whereas 
      those in the cSEMS group (n = 24) underwent a median of 2 (range, 2-12) sessions 
      until ABS resolution (P < .001). A median of 8 (range, 2-32) stents was used 
      until ABS resolution within the MPS group and 1 (range, 1-24) in the cSEMS group 
      (P < .0001). cSEMS migration occurred in 8 (33.3%) patients. Treatment duration 
      did not differ significantly. Initial treatment success rates were high with 23 
      (95.8%) in the MPS group and 24 (100%) for cSEMSs (P = 1). Five (20.8%) patients 
      in both groups showed stricture recurrence after a median follow-up of 500 days 
      (range, 48-1317 days). CONCLUSIONS: cSEMSs for treatment of ABSs needed less 
      endoscopic interventions to achieve similar efficacy as MPS and might become a 
      new treatment standard. However, the optimal duration of cSEMS therapy and 
      cost-efficacy have to be evaluated. (Clinical trial registration number: 
      NCT01393067.).
CI  - Copyright (c) 2017 American Society for Gastrointestinal Endoscopy. Published by 
      Elsevier Inc. All rights reserved.
FAU - Tal, Andrea Oliver
AU  - Tal AO
AD  - Department of Internal Medicine I, Frankfurt University Hospital, Frankfurt, 
      Germany.
FAU - Finkelmeier, Fabian
AU  - Finkelmeier F
AD  - Department of Internal Medicine I, Frankfurt University Hospital, Frankfurt, 
      Germany.
FAU - Filmann, Natalie
AU  - Filmann N
AD  - Institute of Biostatistics and Mathematical Modeling, Frankfurt University 
      Hospital, Frankfurt, Germany.
FAU - Kylanpaa, Leena
AU  - Kylanpaa L
AD  - Department of Gastrointestinal and General Surgery, Helsinki University Central 
      Hospital, Helsinki, Finland.
FAU - Udd, Marianne
AU  - Udd M
AD  - Department of Gastrointestinal and General Surgery, Helsinki University Central 
      Hospital, Helsinki, Finland.
FAU - Parzanese, Ilaria
AU  - Parzanese I
AD  - Department of Gastroenterology, IRCCS Ca Granda, Ospedale Policlinico, Milan, 
      Italy.
FAU - Cantu, Paolo
AU  - Cantu P
AD  - Department of Gastroenterology, IRCCS Ca Granda, Ospedale Policlinico, Milan, 
      Italy.
FAU - Dechene, Alexander
AU  - Dechene A
AD  - Department of Gastroenterology and Hepatology, Universitatsklinikum Essen, Essen, 
      Germany.
FAU - Penndorf, Volker
AU  - Penndorf V
AD  - Department of Gastroenterology and Hepatology, Universitatsklinikum Essen, Essen, 
      Germany.
FAU - Schnitzbauer, Andreas
AU  - Schnitzbauer A
AD  - Department of General and Visceral Surgery, Frankfurt University Hospital, 
      Frankfurt, Germany.
FAU - Friedrich-Rust, Mireen
AU  - Friedrich-Rust M
AD  - Department of Internal Medicine I, Frankfurt University Hospital, Frankfurt, 
      Germany.
FAU - Zeuzem, Stefan
AU  - Zeuzem S
AD  - Department of Internal Medicine I, Frankfurt University Hospital, Frankfurt, 
      Germany.
FAU - Albert, Jorg G
AU  - Albert JG
AD  - Department of Gastroenterology, Hepatology and Endocrinology, Robert-Bosch 
      Hospital, Stuttgart, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT01393067
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170314
PL  - United States
TA  - Gastrointest Endosc
JT  - Gastrointestinal endoscopy
JID - 0010505
RN  - 0 (Plastics)
SB  - IM
CIN - Gastrointest Endosc. 2017 Dec;86(6):1046-1047. PMID: 29146081
MH  - Adult
MH  - Aged
MH  - Anastomosis, Surgical/adverse effects
MH  - Bile Ducts, Extrahepatic/*surgery
MH  - *Cholangiopancreatography, Endoscopic Retrograde
MH  - Cholestasis/etiology/*therapy
MH  - Constriction, Pathologic/etiology/therapy
MH  - Female
MH  - Humans
MH  - Liver Transplantation/adverse effects
MH  - Male
MH  - Middle Aged
MH  - *Plastics
MH  - Prospective Studies
MH  - Prosthesis Failure
MH  - Retreatment
MH  - *Self Expandable Metallic Stents/adverse effects
MH  - Treatment Outcome
EDAT- 2017/03/18 06:00
MHDA- 2018/07/28 06:00
CRDT- 2017/03/18 06:00
PHST- 2016/10/20 00:00 [received]
PHST- 2017/03/05 00:00 [accepted]
PHST- 2017/03/18 06:00 [pubmed]
PHST- 2018/07/28 06:00 [medline]
PHST- 2017/03/18 06:00 [entrez]
AID - S0016-5107(17)30189-X [pii]
AID - 10.1016/j.gie.2017.03.009 [doi]
PST - ppublish
SO  - Gastrointest Endosc. 2017 Dec;86(6):1038-1045. doi: 10.1016/j.gie.2017.03.009. 
      Epub 2017 Mar 14.