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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

4886 - Prospective multicenter feasibility study of laparoscopic sentinel basin dissection after endoscopic submucosal dissection for early gastric cancer.

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Surgical Oncology

Tumour Site

Gastric Cancer

Presenters

Keun Won Ryu

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

K.W. Ryu1, B.W. Eom1, H.M. Yoon1, Y. Kim2, J.S. Min3, G.S. Cho4, I. Cho4, Y.J. Lee5, J. Park5, H. Hur6, Y.K. Park7, O. Jeong7, M.R. Jung7, J.H. Lee8, J.Y. An8

Author affiliations

  • 1 Center For Gastric Center, National Cancer Center, 10408 - Gyeonggi-do/KR
  • 2 Graduate School Of Cancer Science And Policy, National Cancer Center, 10408 - Gyeonggi-do/KR
  • 3 Department Of Surgery, Dongnam Institute of Radiological and Medical Sciences, Cancer Center, Busan/KR
  • 4 Department Of Surgery, Soonchunhyang University College of Medicine, Bucheon/KR
  • 5 Department Of Surgery, Gyeongsang National University, Jinju/KR
  • 6 Department Of Surgery, Ajou University School of Medicine, Suwon/KR
  • 7 Department Of Surgery, Chonnam National University Hwasun Hospital, Hwasun/KR
  • 8 Department Of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul/KR
More

Resources

Abstract 4886

Background

Although standard radical gastrectomy is recommended after non-curative resection of endoscopic submucosal dissection for early gastric cancer, in most cases, no residual tumor and no lymph node metastasis was revealed after surgery. Lymph node metastasis can be evaluated using sentinel basin dissection, however, there was no evidence that sentinel lymph node concept can be applied after endoscopic resection.

Trial design

This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent endoscopic submucosal dissection for clinical stage T1N0M0 gastric cancer and the resections were proven as non-curative were eligible. Qualified investigators who completed the prior phase III trial (Senorita I) are exclusively allowed to participate in this study. Intraoperative endoscopic submucosal injection of a standardized dual tracer was administered to normal mucosa nearby the scar, and sentinel basins were detected using gamma-probe and dissected. Then, standard laparoscopic gastrectomy with lymphadenectomy was performed. Sample size was calculated based on inferior confidence interval of detection rate of 95%, and estimated accrual was 237. The primary and secondary end-points were detection rate and sensitivity of sentinel basin, respectively. This study is expected to evaluate the feasibility of laparoscopic sentinel basin dissection after endoscopic submucosal dissection. If the feasibility is identified, multicenter phase III trial will be started comparing laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.

Clinical trial identification

NCT03123042; registered April 21st, 2017.

Legal entity responsible for the study

Sentinel Node Oriented Tailored Approach (SENORITA) Study Group.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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