Non-exposure Simple Suturing Endoscopic Full-thickness Resection with Sentinel Basin Dissection in Patients with Early Gastric Cancer: the SENORITA 3 Pilot Study.

Abstract

PurposeRecently, non-exposure simple suturing endoscopic full-thickness resection (NESS-EFTR) was developed to prevent tumor exposure to the peritoneal cavity. This study aimed to evaluate the feasibility of NESS-EFTR with sentinel basin dissection for early gastric cancer (EGC).Materials and MethodsThis was the prospective SENORITA 3 pilot. From July 2017 to January 2018, 20 patients with EGC smaller than 3 cm without an absolute indication for endoscopic submucosal dissection were enrolled. The sentinel basin was detected using Tc99m-phytate and indocyanine green, and the NESS-EFTR procedure was performed when all sentinel basin nodes were tumor-free on frozen pathologic examination. We evaluated the complete resection and intraoperative perforation rates as well as the incidence of postoperative complications.ResultsAmong the 20 enrolled patients, one dropped out due to large tumor size, while another underwent conventional laparoscopic gastrectomy due to metastatic sentinel lymph nodes. All NESS-EFTR procedures were performed in 17 of the 18 other patients (94.4%) without conversion, and the complete resection rate was 83.3% (15/18). The intraoperative perforation rate was 27.8% (5/18), and endoscopic clipping or laparoscopic suturing or stapling was performed at the perforation site. There was one case of postoperative complications treated with endoscopic clipping; the others were discharged without any event.ConclusionsNESS-EFTR with sentinel basin dissection is a technically challenging procedure that obtains safe margins, prevents intraoperative perforation, and may be a treatment option for EGC after additional experience.Trial RegistrationClinicalTrials.gov Identifier: NCT03216174