Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01).
10.4174/jkss.2013.84.2.123
- Author:
Hyung Ho KIM
1
;
Sang Uk HAN
;
Min Chan KIM
;
Woo Jin HYUNG
;
Wook KIM
;
Hyuk Joon LEE
;
Seung Wan RYU
;
Gyu Seok CHO
;
Chan Young KIM
;
Han Kwang YANG
;
Do Joong PARK
;
Kyo Young SONG
;
Sang Il LEE
;
Seong Yeob RYU
;
Joo Ho LEE
Author Information
1. Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea. hhkim@snubh.org
- Publication Type:Randomized Controlled Trial ; Original Article
- Keywords:
Gastric cancer;
Laparoscopy distal gastrectomy;
Open distal gastrectomy;
Randomized controlled trial
- MeSH:
Adenocarcinoma;
Disease-Free Survival;
Gastrectomy;
Humans;
Joints;
Korea;
Prospective Studies;
Quality Control;
Quality of Life;
Stomach Neoplasms
- From:Journal of the Korean Surgical Society
2013;84(2):123-130
- CountryRepublic of Korea
- Language:English
-
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).
