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KMID : 0371320130840020123
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Journal of the Korean Surgical Society
2013 Volume.84 No. 2 p.123 ~ p.130
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Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01)
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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-IL
Ryu Seong-Yeob
Lee Joo-Ho
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Abstract
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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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KEYWORD
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Gastric cancer, Laparoscopy distal gastrectomy, Open distal gastrectomy, Randomized controlled trial
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