National Cancer Center, Goyang, South Korea
Keun Won Ryu , Ji Yeon Park , Young Woo Kim , Byung-Ho Nam , Young Joon Lee , Sang-Ho Jeong , Ji-Ho Park , Hoon Hur , Sang Uk Han , Jae-Seok Min , Ji Yeong An , Woo Jin Hyung , Gyu Seok Cho , Gui Ae Jeong , Oh Jeong , Young-Kyu Park , Mi Ran Jung , Hong Man Yoon , Bang Wool Eom
Background: Along with marked increase in early gastric cancer (EGC) in Eastern countries, there has been an effort to adopt sentinel node concept in EGC to reduce immediate postoperative complications and preserve gastric function. Based on the promising results from the previous quality control study prior to phase III trial, this prospective multicenter randomized controlled trial aimed to elucidate the oncologic safety of laparoscopic stomach-preserving surgery with sentinel basin dissection (SBD) compared to standard laparoscopic gastrectomy. Methods: This trial is an investigator-initiated, open-label, multicenter randomized controlled phase III trial with non-inferiority design. Patients diagnosed with a single lesion of clinical stage T1N0M0 gastric adenocarcinoma with a diameter of 3cm or less are eligible for the present study. A total of 580 patients (290 per each group) will be randomized to either laparoscopic stomach-preserving surgery with SBD or standard surgery. The primary end-point is 3-year disease-free survival (DFS) and the secondary endpoints include postoperative morbidity and mortality, quality of life, and 5-year DFS and overall survival. The qualified investigators who completed the prior quality control study are exclusively allowed to participate in this phase III clinical trial. Discussion: The proposed trial is expected to verify whether laparoscopic stomach-preserving surgery with SBD achieves the similar oncologic outcomes and improved quality of life compared to the standard gastrectomy in EGC patients. Clinical trial information: NCT01804998
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Abstract Disclosures
2021 ASCO Annual Meeting
First Author: Bang Wool Eom
2023 ASCO Annual Meeting
First Author: Bang Wool Eom
2020 ASCO Virtual Scientific Program
First Author: Keun Won Ryu
2023 ASCO Gastrointestinal Cancers Symposium
First Author: Chul Hyo Jeon