Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01)open access
- Authors
- Kim, Hyung-Ho; Han, Sang-Uk; Kim, Min-Chan; Hyung, Woo Jin; Kim, Wook; Lee, Hyuk-Joon; Ryu, Seung Wan; Cho, Gyu Seok; Kim, Chan Young; Yang, Han-Kwang; Park, Do Joong; Song, Kyo Young; Lee, Sang I. L.; Ryu, Seong Yeob; Lee, Joo Ho
- Issue Date
- Feb-2013
- Publisher
- KOREAN SURGICAL SOCIETY
- Keywords
- Gastric cancer; Laparoscopy distal gastrectomy; Open distal gastrectomy; Randomized controlled trial
- Citation
- JOURNAL OF THE KOREAN SURGICAL SOCIETY, v.84, no.2, pp 123 - 130
- Pages
- 8
- Journal Title
- JOURNAL OF THE KOREAN SURGICAL SOCIETY
- Volume
- 84
- Number
- 2
- Start Page
- 123
- End Page
- 130
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/74764
- DOI
- 10.4174/jkss.2013.84.2.123
- ISSN
- 2233-7903
2093-0488
- Abstract
- A randomized controlled trial to evaluate the long-term outcomes of laparoscopic distal gastrectomy for gastric cancer is currently ongoing in Korea. Patients with cT1N0M0-cT2aN0M0 (American Joint Committee on Cancer, 6th edition) distal gastric cancer were randomized to receive either laparoscopic or open distal gastrectomy. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 cases each of laparoscopy-assisted distal gastrectomy and open distal gastrectomy and their institutions should have performed more than 80 cases each of both procedures each year. Fifteen surgeons from 12 institutions recruited 1,415 patients. The primary endpoint is overall survival. The secondary endpoints are disease-free survival, morbidity, mortality, quality of life, inflammatory and immune responses, and cost-effectiveness (ClinicalTrials.gov ID: NCT00452751).
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