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

Andrea Oliver Tal, Fabian Finkelmeier, Natalie Filmann, Leena Kylänpää, Marianne Udd, Ilaria Parzanese, Paolo Cantù, Alexander Dechêne, Volker Penndorf, Andreas Schnitzbauer, Mireen Friedrich-Rust, Stefan Zeuzem, Jörg G. Albert

Research output: Contribution to journalArticlepeer-review

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.)

Original languageEnglish
Pages (from-to)1038-1045
Number of pages8
JournalGastrointestinal Endoscopy
Volume86
Issue number6
DOIs
Publication statusPublished - Dec 1 2017

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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