Endoscopic treatment of biliary strictures after orthotopic liver transplantation: balloon dilatation versus stent placement. A prospective, controlled trial

Background and Study Aims: Biliary strictures are a major cause of morbidity following liver transplantation (LTX) with a variable incidence between 6 and 20%. Endoscopic therapy with balloon dilation, placement of plastic stents and combination of both procedures has been shown to be effective. Despite these successful reports, a valid, endoscopic therapeutic regimen is not defined. In the present prospective controlled trial, we compared balloon dilation vs. balloon dilation plus stenting with regard to technical and clinical efficacy as well as complications.

Patients and Methods: A total of 31 patients with symptomatic biliary stricture after LTX were assigned to ballon dilation (n=16) or balloon dilation plus plastic stent (n=15). The groups were not statistically different with respect to gender, age, cause of underlying liver disease and type of biliary stricture (i.e. anastomotic, donor duct, hilus). The primary end point was the sustained clinical success defined as an interval of 3 months without further endoscopic intervention. Additional endpoints were assisted clinical success and treatment failure. Number of endoscopic interventions and complications of the procedures were monitored.

Results: The initial technical success and primary clinical success rate in the dilation group was 100%. In the stent group, corresponding rates were 100% and 93%, respectively (ns). The sustained clinical success was 62.5% in the dilation group and 66.6% in the stent group (ns). The time interval to reach sustained clinical success was 6.4 and 5.6 months respectively (ns). In 4 additional patients in the dilation group and one patient in the stent group an assisted clinical success with ongoing therapy could be achieved. In both groups a median of 5 sessions was required and in both groups in 3 patients a switch of treatment was performed. Treatment failure occurred in 2 patients of the dilation group and 4 patients of the stent group. Complications were observed in 2 of 84 procedures in the dilation group (2.3%) and 11 of 90 procedures in the stent group (12.2%, p<0.05). Follow up was 16.5 and 13.5 months respectively. Independent of the treatment group, an overall clinical success in anastomotic strictures was achieved in 100%, whereas the success rate of strictures of the donor hepatic duct was 66% and of strictures involving the hilus 43% (p<0.05)

Conclusions: In patients with biliary strictures after LTX, endoscopic balloon dilatation was equally effective compared to stent placement. Stent placement was associated with a significantly higher complication rate. Endoscopic treatment of strictures of the biliary anastomosis is highly effective, whereas attempts to treat strictures of the donor duct or the biliary hilus are less promising.

Keywords: biliary stricture, bile duct, ERCP, liver transplantation, balloon dilatation