Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01)
- Affiliated Author(s)
- 류승완
- Alternative Author(s)
- Ryu, Seung Wan
- Journal Title
- Journal of the Korean Surgical Society
- ISSN
- 2233-7903
- Issued Date
- 2013
- Keyword
- Gastric cancer; Laparoscopy distal gastrectomy; Open distal gastrectomy; Randomized controlled trial
- 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.
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