J Gastric Cancer.  2019 Jun;19(2):157-164. 10.5230/jgc.2019.19.e12.

Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol

Affiliations
  • 1Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea. docryu@ncc.re.kr
  • 2Department of Surgery, Dongnam Institute of Radiological and Medical Science, Busan, Korea.
  • 3Department of Surgery, Soonchunhyang University College of Medicine, Bucheon, Korea.
  • 4Department of Surgery, Gyeongsang National University, Jinju, Korea.
  • 5Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun, Korea.
  • 6Department of Surgery, Ajou University School of Medicine, Suwon, Korea.
  • 7Biometric Research Branch, Research Institute for National Cancer Control & Evaluation, National Cancer Center, Goyang, Korea.

Abstract

PURPOSE
Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD.
MATERIALS AND METHODS
This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications.
CONCLUSIONS
This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03123042

Keyword

Gastric cancer; Sentinel lymph node; Endoscopic submucosal dissection

MeSH Terms

Feasibility Studies*
Gastrectomy
Humans
Indocyanine Green
Lymph Node Excision
Lymph Nodes
Neoplasm Metastasis
Neoplasm, Residual
Optical Imaging
Postoperative Complications
Prospective Studies*
Research Personnel
Sample Size
Stomach Neoplasms*
Indocyanine Green
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