Preliminary report of Non-exposure simple suturing endoscopic full-thickness resection (NESS-EFTR) for early gastric cancer (SENORITA 3 study)

Aims Non-exposure simple suturing endoscopic full-thickness resection (NESS-EFTR) was developed to prevent tumor exposure to the peritoneal cavity during EFTR. The aim of this study was to evaluate the feasibility of NESS-EFTR for early gastric cancer (EGC).

Methods This trial is a prospective phase II trial. Patients with EGC less than 3 cm in size without absolute indication for endoscopic submucosal dissection were eligible. Sentinel basin was detected using Tc^99m-phytate and indocyanine green, and the NESS-EFTR procedure was performed when all sentinel basin nodes were tumor-free by frozen pathologic examination. The primary outcome was the rate of complete resection, and secondary outcomes were the rate of successful NESS-EFTR. Estimated sample size is 88 patients.

Results This is the preliminary report of 44 patients where half of target sample size is registered. Six patients received conventional laparoscopic gastrectomy because metastatic sentinel lymph nodes were detected (n=5) or withdrew consent. NESS-EFTR was successful in 34 of the 38 remaining patients (89.4%). Reasons of failure of NESS-EFTR were unclear tumor margin (n=2) or perforations which could not be controlled by endoscopic procedure (n=2).

Complete resection rate as a primary endpoint was 89.4% (34/38). In cases of incomplete resection, immediate additional intraoperative endoscopic submucosal dissections (n=3) or argon plasma coagulation (n=1) was performed. There were four perforations.

Conclusions Early preliminary data shows NESS-EFTR with sentinel basin dissection is promising. This study is expected to clarify the feasibility NESS-EFTR with sentinel basin dissection for EGC.

Conflicts of interest

Authors do not have any conflict of interest to disclose.

Publication History

Article published online:
14 April 2023