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Gastrointest Endosc. 2017 Dec;86(6):1038-1045. doi: 10.1016/j.gie.2017.03.009. Epub 2017 Mar 14.

Multiple plastic stents versus covered metal stent for treatment of anastomotic biliary strictures after liver transplantation: a prospective, randomized, multicenter trial.

Author information

1
Department of Internal Medicine I, Frankfurt University Hospital, Frankfurt, Germany.
2
Institute of Biostatistics and Mathematical Modeling, Frankfurt University Hospital, Frankfurt, Germany.
3
Department of Gastrointestinal and General Surgery, Helsinki University Central Hospital, Helsinki, Finland.
4
Department of Gastroenterology, IRCCS Cà Granda, Ospedale Policlinico, Milan, Italy.
5
Department of Gastroenterology and Hepatology, Universitätsklinikum Essen, Essen, Germany.
6
Department of General and Visceral Surgery, Frankfurt University Hospital, Frankfurt, Germany.
7
Department of Gastroenterology, Hepatology and Endocrinology, Robert-Bosch Hospital, Stuttgart, Germany.

Abstract

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.).

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PMID:
28302527
DOI:
10.1016/j.gie.2017.03.009
[Indexed for MEDLINE]

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