NON-EXPOSURE SIMPLE SUTURING ENDOSCOPIC FULL-THICKNESS RESECTION (NESS-EFTR) WITH SENTINEL BASIN DISSECTION IN PATIENTS WITH EARLY GASTRIC CANCER, SENORITA 3 PILOT STUDY

Aims Recently, non-exposure simple suturing endoscopic full-thickness resection (NESS-EFTR) was developed, and this procedure was designed to prevent tumor exposure to the peritoneal cavity. The aim of this study was to evaluate the feasibility of NESS-EFTR with sentinel basin dissection for early gastric cancer.

Methods This study is a prospective pilot study (SENORITA 3 pilot). From July 2017 to January 2018, twenty patients with early gastric cancer less than 3 cm in size without absolute indication for endoscopic submucosal dissection were enrolled. 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 intraoperative perforation and the incidence of postoperative complication.

Results Among 20 enrolled patients, one patient dropped out due to large tumor size, and one underwent conventional laparoscopic gastrectomy due to metastatic sentinel lymph nodes. NESS-EFTR was successful in 17 of the 18 remaining patients (94.4%), and the complete resection rate was 83.3% (15/18). The rate of intraoperative perforation during EFTR 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 complication which was treated with endoscopic clipping and others were discharged without any event.

Conclusions NESS-EFTR with sentinel basin dissection is a feasible treatment option for early gastric cancer. Further phase II study is needed.

 

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