Feasibility of laparoscopic endoscopic cooperative surgery for non-ampullary superficial duodenal neoplasms: A single-arm confirmatory trial.

OBJECTIVE: Laparoscopic endoscopic cooperative surgery for duodenal tumors (D-LECS) has been developed to prevent duodenal leakage by reinforcing the ESD site. However, there has been no prospective trial showing the feasibility of D-LECS. Herein, we conducted a single-arm confirmatory trial to evaluate the safety of D-LECS for non-ampullary superficial duodenal neoplasms.

METHODS: This prospective single-center single-arm confirmatory trial analyzed patients with non-ampullary superficial duodenal neoplasms who underwent D-LECS. The primary endpoint was the incidence of any postoperative leakage occurring on the duodenal wall within 1 month postoperatively. The planned sample size was 20 patients, considering a threshold of 28% and one-sided alpha value of 5%.

RESULTS: Between January 2015 and September 2018, 20 eligible patients were enrolled. Sixteen tumors were located in the second portion, three in the first portion, and one in the third portion of the duodenal region. The median operative time was 225 (134-361) min and the median blood loss was 0 (0-150) ml. Curative resection (R0) with negative margins was achieved in 19 cases. One case of postoperative leakage and one case of bleeding of grade 2 according to the Clavien-Dindo classification were observed in this series. The median duration of postoperative hospital stay was 9 (5-12) days. No local recurrence was observed in any patient during the median follow-up of 15.0 (12.0-38.0) months.

CONCLUSIONS: This trial confirmed the safety and feasibility of D-LECS for non-ampullary superficial duodenal neoplasms with respect to the low incidence of postoperative duodenal leakage.