Feasibility of laparoscopic endoscopic cooperative surgery for non‐ampullary superficial duodenal neoplasms: Single‐arm confirmatory trial

Abstract

Objective Laparoscopic endoscopic cooperative surgery for duodenal tumors (D‐LECS) has been developed to prevent duodenal leakage by reinforcing the endoscopic submucosal dissection 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.

Issues and Prospects of Current Endoscopic Treatment Strategy for Superficial Non-Ampullary Duodenal Epithelial Tumors

“…Although LECS was developed for gastric submucosal tumors [ 27 ], it has also been adapted for duodenal tumors (D-LECS) [ 28 , 29 ]. D-LECS can be divided into two types depending on whether performing perforation during endoscopic treatment: full-thickness resection (with perforation: D-LECS with FTR) or ESD with reinforcement using a laparoscopic approach (without perforation: D-LECS with ESD).…”

Clinicopathological features and management strategy for superficial nonampullary duodenal tumors: a multi-center retrospective study

“…Until now, few studies have compared LECS and laparoscopy-only groups for duodenal tumors, and most were single-arm confirmatory trials, case reports, or offered only technical tips regarding LECS [ 9 10 12 13 ]. As a comparative study, Ojima et al [ 11 ] concluded that LECS was an ideal alternative to endoscopic resection for low-risk duodenal tumors in terms of complication and curative resection rates.…”

“…Laparoscopic resection may adequately treat SNADTs. However, difficulty in determining tumor location may lead to unnecessary laparoscopic duodenal resection [ 10 ]. Laparoscopic endoscopic cooperative surgery (LECS), which exploits the advantages and minimizes the disadvantages of endoscopic and laparoscopic treatments, may be appropriate [ 9 10 11 12 13 ].…”

The mucin phenotype does not affect the endoscopic resection outcome of non-ampullary duodenal epithelial tumors

“…Considering the much higher risk of AEs with ESD, several endoscopic methods, such as line-assisted closure 8 , ENBPD 9 and over-the-scope clip closure 10 11 have been introduced for the prevention of AEs. More recently, Kanaji et al reported the safety and feasibility of laparoscopic cooperative surgery for duodenal tumors (D-LECS) 29 . In the present study, AEs occurred in four cases treated by ESD.…”