PMID- 28455159
OWN - NLM
STAT- MEDLINE
DCOM- 20180822
LR  - 20220410
IS  - 1097-6779 (Electronic)
IS  - 0016-5107 (Linking)
VI  - 87
IP  - 1
DP  - 2018 Jan
TI  - Metal versus plastic stents for anastomotic biliary strictures after liver 
      transplantation: a randomized controlled trial.
PG  - 131.e1-131.e13
LID - S0016-5107(17)31815-1 [pii]
LID - 10.1016/j.gie.2017.04.013 [doi]
AB  - BACKGROUND AND AIMS: Biliary anastomotic stricture occurs in 15% to 20% of 
      patients after deceased orthotopic liver transplantation (OLT). It is usually 
      treated endoscopically with multiple plastic stents (MPSs), although the use of 
      fully covered self-expandable metal stents (cSEMSs) is emerging. This study aims 
      to compare the efficacy and safety of cSEMSs versus MPSs in these patients. 
      METHODS: A single-center, open-label, randomized clinical trial was performed. 
      Patients were randomized to single cSEMSs for 6 months or to MPS placement, 
      exchanged every 3 months over 1 year. The primary outcome was stricture 
      resolution. Crossover therapy was considered for failure or recurrence. Secondary 
      outcomes were sustained improvement, morbidity, and mortality. RESULTS: Between 
      October 2009 and January 2014, 162 patients with post-OLT biliary adverse events 
      were assessed for eligibility. Sixty-four were prospectively randomized (1:1) to 
      cSEMSs or MPSs. Baseline characteristics were comparable. Technical success was 
      100%. Median follow-up was 36.4 and 32.9 months for the cSEMS and MPS groups, 
      stricture resolution at last stent removal was achieved in 83.3% and 96.5% (P = 
      .19), and stricture recurrence was observed in 32% and 0%, respectively (P < 
      .01). Adverse events occurred in 23.3% and 6.4% of ERCPs in the cSEMS and MPS 
      groups, respectively (P < .01), with 13.3% of acute pancreatitis in the cSEMS 
      group and 2.1% in the MPS group (P < .01). CONCLUSIONS: cSEMSs were comparable 
      with MPSs regarding post-OLT biliary anastomotic stricture resolution. cSEMSs 
      allowed fewer procedures and had a positive effect on cost. Duration of treatment 
      with cSEMSs should be further investigated. Sphincterotomy should be considered 
      for all patients. (Clinical trial registration number: NCT 01148199.).
CI  - Copyright (c) 2018 American Society for Gastrointestinal Endoscopy. Published by 
      Elsevier Inc. All rights reserved.
FAU - Martins, Fernanda Prata
AU  - Martins FP
AD  - Endoscopy Unit, Hospital Israelita Albert Einstein, Sao Paulo SP, Brazil.
FAU - De Paulo, Gustavo Andrade
AU  - De Paulo GA
AD  - Endoscopy Unit, Hospital Israelita Albert Einstein, Sao Paulo SP, Brazil.
FAU - Contini, Monica L C
AU  - Contini MLC
AD  - Endoscopy Unit, Hospital Israelita Albert Einstein, Sao Paulo SP, Brazil.
FAU - Ferrari, Angelo Paulo
AU  - Ferrari AP
AD  - Endoscopy Unit, Hospital Israelita Albert Einstein, Sao Paulo SP, Brazil.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170425
PL  - United States
TA  - Gastrointest Endosc
JT  - Gastrointestinal endoscopy
JID - 0010505
RN  - 0 (Plastics)
SB  - IM
CIN - Gastrointest Endosc. 2019 Mar;89(3):650-651. PMID: 30784508
CIN - Gastrointest Endosc. 2019 Mar;89(3):651-652. PMID: 30784509
MH  - Adult
MH  - Aged
MH  - Anastomosis, Surgical
MH  - Bile Ducts/*surgery
MH  - *Biliary Tract Surgical Procedures
MH  - Cholangiopancreatography, Endoscopic Retrograde/*instrumentation/methods
MH  - Cholestasis/*surgery
MH  - Constriction, Pathologic/surgery
MH  - Device Removal
MH  - Female
MH  - Humans
MH  - *Liver Transplantation
MH  - Logistic Models
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - *Plastics
MH  - Postoperative Complications/*surgery
MH  - *Self Expandable Metallic Stents
MH  - Sphincterotomy, Endoscopic/methods
MH  - Stents
MH  - Young Adult
EDAT- 2017/04/30 06:00
MHDA- 2018/08/23 06:00
CRDT- 2017/04/30 06:00
PHST- 2017/01/19 00:00 [received]
PHST- 2017/04/17 00:00 [accepted]
PHST- 2017/04/30 06:00 [pubmed]
PHST- 2018/08/23 06:00 [medline]
PHST- 2017/04/30 06:00 [entrez]
AID - S0016-5107(17)31815-1 [pii]
AID - 10.1016/j.gie.2017.04.013 [doi]
PST - ppublish
SO  - Gastrointest Endosc. 2018 Jan;87(1):131.e1-131.e13. doi: 
      10.1016/j.gie.2017.04.013. Epub 2017 Apr 25.