Metal versus plastic stents for anastomotic biliary strictures after liver transplantation: a randomized controlled trial

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.) 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. 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. 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). 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.)