RESUMEN
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.).