Aims The primary aim of the study is to evaluate the migration rate of new fully covered
self-expanding metal stent with anti-migration flap (Hanaro, M.I. Tech, Seoul, Korea)
in patients with anastomotic biliary stricture after liver transplantation over a
period of 6 months. The secondary aim is to evaluate the clinical success of this
treatment at 6 months follow up.
Methods From January 2018 to December 2021, we prospectively enrolled patients with anastomotic
stricture after OLT, in 4 centers of the BASALT study group, with high experience
in the endoscopic treatment of complications after liver transplantation. A novel
type of biliary FCSEMS with a proximal and distal anti-migration flaps was placed
by experienced endoscopists. The deployed stent diameter is 10 mm. After 6 months,
stent were removed and patients were followed for at least 6 months. At the time of
stent removal, cholangiography was performed to confirm resolution of the anastomotic
stricture. Long-term outcome was evaluated by biochemical-clinical data (at 3 and
6 months) and MRchongiography at 6 months after removal of stent.
Results Overall, 78 patients (64 males), were enrolled in the study. All procedure was completed.
At the end of the indwelling period, the migration rate was 5% (4/74) while the dislocation
rate was 15% (11/74). Complete resolution of the stenosis was achieved in 81% of cases
(60/74). Among the 78 patients, 20 of them (25%) developed early anastomotic stricture
(before 6 months of OLT). Regarding complications, 3 of 78 patients (4%) developed
periprocedural complications (mild pancreatitis). 5 of 78 patients (6%) experienced
episodes of cholangitis, 3 of which required early removal of the FCMSEM at 109, 93
and 68 days after placement. 2/78 (2.5%) early occlusions of the prosthesis. In 5
cases out of 78 (6%) early removal was necessary (2 for episodes of pancreatitis,
2 for acute cholangitis, 1 for early obstruction of the stent). At the 6 months of
follow up the early recurrence were treated either with a new FCSEMS or with a multistenting
or went to surgery.
Conclusions A new fully covered self-expanding metal stent with a double anti-migration flap
has a low risk of migration and has been shown to be effective in the treatment of
anastomotic strictures after liver transplantation in the early follow up. Even if
more extensive studies are necessary to confirm on a larger series of cases the data
obtained and to evaluate the risks of complications linked to this new device.
