Temporary placement of covered self-expandable metallic stents in patients with biliary leak: midterm evaluation of a pilot study.

Background: Management of biliary leaks includes ERCP and stent placement. The ability to temporarily place a partially covered self-expandable metallic stent (CSEMS) might offer an advantage in the treatment of biliary leaks. Objective: We analyzed our 2 years'' experience when using this innovative technique. Design: Patients in whom a previous ERCP had failed to resolve a bile leak or patients with severe comorbidities were offered CSEMS and were followed prospectively for clinical and radiologic responses. Setting: Tertiary-care center with long-standing experience of using CSEMS. Patients: A total of 16 patients were included. Of these, 7 had previously undergone unsuccessful plastic stent placement, 3 had previously failed ERCP, and 7 had severe comorbidities that prevented multiple interventions. Intervention: ERCP with placement of a CSEMS covering the cystic duct take-off in the case of a cystic-stump leak. CSEMS were removed after resolution of the leak. Main Outcome Measurements: Efficacy and safety of the CSEMS in bile leaks; complications were also evaluated. Results: Of the patients studied, 15 responded to CSEMS placement with complete resolution of the leak on imaging. One patient with partial cholecystectomy relapsed and underwent drainage; another patient responded to the treatment but required revision because of migration. CSEMS were left in place for a median time of 3 months (range, 1-17 months). Complications included 1 proximal and 1 distal migration. Limitations: Pilot study from a single center. Conclusions: CSEMS is an excellent option in this subgroup of patients not responding to plastic stent placement or with severe comorbidities. [Copyright &y& Elsevier]