Detailed Information

Cited 53 time in webofscience Cited 0 time in scopus
Metadata Downloads

Assessment of laparoscopic stomach preserving surgery with sentinel basin dissection versus standard gastrectomy with lymphadenectomy in early gastric cancer-A multicenter randomized phase III clinical trial (SENORITA trial) protocol

Authors
Park, Ji YeonKim, Young-WooRyu, Keun WonNam, Byung-HoLee, Young JoonJeong, Sang HoPark, Ji-HoHur, HoonHan, Sang-UkMin, Jae SeokAn, Ji YeongHyung, Woo JinCho, Gyu SeokJeong, Gui AeJeong, OhPark, Young KyuJung, Mi RanYoon, Hong ManEom, Bang Wool
Issue Date
May-2016
Publisher
BioMed Central
Keywords
Phase III clinical trial; Gastric cancer; Sentinel lymph node; Laparoscopic surgery
Citation
BMC Cancer, v.16
Indexed
SCIE
SCOPUS
Journal Title
BMC Cancer
Volume
16
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/66228
DOI
10.1186/s12885-016-2336-8
ISSN
1471-2407
Abstract
Background: Along with the marked increase in early gastric cancer (EGC) in the Eastern countries, there has been an effort to adopt the sentinel node concept in EGC to preserve gastric function and reduce the occurrence of postoperative complications. Based on promising results from a previous quality control study, this prospective multicenter randomized controlled phase III clinical trial aims to elucidate the oncologic safety of laparoscopic stomach-preserving surgery with sentinel basin dissection (SBD) compared to a standard laparoscopic gastrectomy. Methods/Design: This trial is an investigator-initiated, open-label, multicenter randomized controlled phase III trial with a non-inferiority design. Patients diagnosed with a single lesion of clinical stage T1N0M0 gastric adenocarcinoma, with a diameter of 3 cm or less are eligible for the present study. A total of 580 patients (290 per 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, 5-year DFS, and overall survival. 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 similar oncologic outcomes and improved quality of life compared to a standard gastrectomy in EGC patients.
Files in This Item
There are no files associated with this item.
Appears in
Collections
5. Others > ETC > 1. Journal Articles

qrcode

Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.

Related Researcher

Researcher Min, Jae Seok photo

Min, Jae Seok
Anam Hospital (Department of Foregut Surgery, Anam Hospital)
Read more

Altmetrics

Total Views & Downloads

BROWSE