A randomized trial of a fully covered self-expandable metallic stent versus plastic stents in anastomotic biliary strictures after liver transplantation

Abstract

Background: Post-liver-transplant biliary anastomotic strictures (ASs) are currently managed with repeated endoscopic retrograde cholangiopancreatographies (ERCPs) inserting multiple plastic stents. Fully covered self-expanding metal stents (FCSEMSs) are being increasingly reported in the management of this condition, however no prospective randomized trials have been performed to date. Aim: The aim of this study was to determine whether FCSEMSs decrease overall numbers of ERCPs needed to achieve stricture resolution and to establish the safety, efficacy and costeffectiveness in this setting. Methods: Two tertiary referral centres performed this open-label prospective randomized trial. A total of 32 patients consented and subsequently 20 were randomized with 10 in the FCSEMS arm and 10 in the plastic arm. The FCSEMS arm had the stent in situ for 12 weeks with the plastic stent arm undergoing 3-monthly multiple plastic stenting with or without dilatation over a year. Results: The median number of ERCPs performed per patient in the FCSEMS was 2 versus 4.5 (p = 0.0001) in the plastic stenting arm. Stricture resolution was achieved in all 10 patients with FCSEMSs compared with 8/10 in the plastic arm [p = not significant (NS)]. Complications occurred in 1/10 patients in the FCSEMS arm versus 5/10 in the plastic arm (p = 0.051). Days in hospital for complications was 6 in the FCSEMS versus 56 in the plastic arm (p = 0.11). Cost analysis shows that the FCSEMS arm was more cost effective. No cases of FCSEMS migration were seen. Conclusions: FCSEMSs reduced the number of ERCPs needed to achieve stricture resolution with similar recurrence rates between arms. The FCSEMSs may do so with fewer complications making it cost effective.

Definitive outcomes of self-expandable metal stents in patients with refractory post-transplant biliary anastomotic stenosis

“…Stricture resolution rates are high, often over 80%, which is similar or better when compared with published series of plastic stent use [12][13][14]. Only one published open label randomized study compared FCSEMS and plastic stents, but this study has important limitations because of the small sample size, the high complication rate in the plastic stent arm, and the suboptimal treatment of the plastic stent group [13].…”

“…Only one published open label randomized study compared FCSEMS and plastic stents, but this study has important limitations because of the small sample size, the high complication rate in the plastic stent arm, and the suboptimal treatment of the plastic stent group [13]. Unfortunately, there are no welldesigned randomized, controlled trials comparing the efficacy of treatment with plastic stents with that of FCSEMS.…”

“…Compared with a multiple plastic stents, the potential benefits of a single FCSEMS are in its relative simplicity and the need for only two ERCP procedures, one for insertion and the other for removal. Multiple case series have been published using such stents after liver transplantation, with generally good outcomes [6,8,[11][12][13].…”

Percutaneous transhepatic techniques for management of biliary anastomotic strictures in living donor liver transplant recipients

“…The main limitations of using metallic stents are stent migration, and early reocclusion. [26] In our series, we used covered metallic stents in 2 patients. Clinical success was achieved in both the patients.…”

Management issues in post living donor liver transplant biliary strictures

“…However, most of the data is in post DDLT strictures [46,47] . The smaller size of donor liver ducts as well as very short common duct stump and discrepancy between recipient and donor duct size make it unsuitable for use in LDLT strictures.…”