Short summary

Benign biliary stenoses are a frequent complication of chronic pancreatitis, surgical intervention, primary sclerosing cholangitis, or gallstones. These stenoses are traditionally treated with plastic stents inserted at endoscopy (ERCP). However, up to 20% of patients develop stent failure requiring intervention. The aim of this study was to evaluate if treatment of patients with benign biliary stenosis with ant migrating self-expandable metal stents is associated with a lower rate of complications compared to treatment with plastic stents.

Rationale

Benign biliary stenoses are a frequent complication of chronic pancreatitis, surgical intervention (cholecystectomy or liver transplantation), primary sclerosing cholangitis, or gallstones. These stenoses are traditionally treated with plastic stents inserted at endoscopy (ERCP). However, up to 20% of patients develop stent failure requiring intervention. In theory, use of ant migrating self-expandable metal stents (SEMS) may be associated with a lower rate of stent failure. The aim of this study was to evaluate if treatment of patients with benign biliary stenosis with SEMS is associated with a lower rate of complications compared to treatment with plastic stents. The study is designed as a multicenter, randomized clinical trial where patients are randomized (1:1 ratio) during the primary ERCP to receive treatment with either plastic stents or SEMS. All patients are treated with stents for a period of one year. Following stent removal, patients are followed-up for a period of two years to detect any signs of redevelopment of the biliary stenosis.

Description of the cohort

Patients older than 18 years who are diagnosed at ERCP with a symptomatic benign biliary stenosis at one of the participating centers are included. Patients with suspected malignant disease (in the biliary tract or other organs), or autoimmune pancreatitis are excluded.

Data and biological material

The following data is registered:

1. Patients characteristics
2. Description of the identified stenosis
3. Blood tests
4. Intervention performed (dilation, type, length and number of stents inserted)
5. Complications (stentdysfunction, pancreatitis, others)
6. Redevelopment of stenosis following final removal of stents

Collaborating researchers and departments

Department of Gastroenterology, Hvidovre Hospital

• Palle Nordblad Schmidt, MD
• John Gásdal Karstensen, MD

Department of Gastrointestinal Surgery, Aalborg University Hospital

• Per Ejstrud, MD

Department of gastroenterology, Køge Hospital

• Lasse Bremholm Hansen, MD