Surgical or endoscopic management for post-ERCP large transmural duodenal perforations: a randomized prospective trial.

INTRODUCTION: Duodenal perforations are an uncommon adverse event during ERCP. Patients can develop significant morbidity and mortality. Even though surgery has been used to manage duodenal complications, therapeutic endoscopy has seen significant advances. OBJECTIVE: To compare endoscopic approach with surgical intervention in patients with duodenal perforations post-ERCP. MATERIAL AND METHODS: prospective randomized study in a tertiary center with 23 patients divided in 2 groups. Within 12 hours after the event, the patients underwent endoscopic or surgical approach. Endoscopic approach included closure of the perforation with endoclips and SEMS. Surgical repair included hepaticojejunostomy, suture of the perforation or duodenal suture. The success was defined as closure of the defect. Secondary outcomes included mortality, adverse events, days of hospitalization and costs. RESULTS: The success was 100% in both groups. There was one death in the endoscopic group secondary to sepsis. There was no statistical difference in mortality or adverse events. We noticed statistical difference in favor of the endoscopic group considering shorter hospitalization (4.1 days versus 15.2 days, with p=0.0123) and lower cost per patient (U$14,700 versus U$19,872, with p=0.0103). CONCLUSIONS: Endoscopic approach with SEMS and endoclips is an alternative to surgery in large transmural duodenal perforations post-ERCP.