Abstract
Background and Aims: Minimally invasive treatments of anastomotic benign biliary stricture (BBS) after orthotopic liver transplantation (OLT) include endoscopic placement of multiple plastic stents or fully covered selfexpandable metal stents (FCSEMSs). No multiyear efficacy data are available on FCSEMS treatment after OLT.
Methods: We prospectively studied long-term efficacy and safety of FCSEMS treatment in adults aged 18 years
with past OLT, cholangiographically confirmed BBS, and an indication for ERCP with stent placement. Stent
removal was planned after 4 to 6 months, with subsequent follow-up until 5 years or stricture recurrence.
Long-term outcomes were freedom from stricture recurrence, freedom from recurrent stent placement, and
stent-related serious adverse events (SAEs).
Results: In 41 patients, long-term follow-up began after FCSEMS removal (n Z 33) or observation of complete
distal migration (CDM) (n Z 8). On an intention-to-treat basis, the 5-year probability of remaining stent-free after
FCSEMS removal or observation of CDM was 48.9% (95% confidence interval [CI], 33.2%-64.7%) among all patients and 60.9% (95% CI, 43.6%-78.2%) among 31 patients with over 4 months of FCSEMS indwell time. In 28
patients with stricture resolution at FCSEMS removal or observed CDM (median, 5.0 months indwell time),
the 5-year probability of no stricture recurrence was 72.6% (95% CI, 55.3%-90%). Sixteen patients (39%) had at
least 1 related SAE, most commonly cholangitis (n Z 10).
Conclusions: By 5 years after temporary FCSEMS treatment of post-OLT BBS, approximately half of all patients
remained stent-free on an intention-to-treat basis. Stent-related SAEs (especially cholangitis) were common.
FCSEMS placement is a viable long-term treatment option for patients with post-OLT BBS.