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.