title: Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01).
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).
authors: Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
authors: Hyung-Ho
authors: HH
authors: Kim
authors: Sang-Uk
authors: SU
authors: Han
authors: Min-Chan
authors: MC
authors: Kim
authors: Woo Jin
authors: WJ
authors: Hyung
authors: Wook
authors: W
authors: Kim
authors: Hyuk-Joon
authors: HJ
authors: Lee
authors: Seung Wan
authors: SW
authors: Ryu
authors: Gyu Seok
authors: GS
authors: Cho
authors: Chan Young
authors: CY
authors: Kim
authors: Han-Kwang
authors: HK
authors: Yang
authors: Do Joong
authors: DJ
authors: Park
authors: Kyo Young
authors: KY
authors: Song
authors: Sang Il
authors: SI
authors: Lee
authors: Seong Yeob
authors: SY
authors: Ryu
authors: Joo Ho
authors: JH
authors: Lee
keywords: Gastric cancer; Laparoscopy distal gastrectomy; Open distal gastrectomy; Randomized controlled trial
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