Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01)
Open Access
- 1 January 2013
- journal article
- Published by The Korean Surgical Society in Journal of the Korean Surgical Society
- Vol. 84 (2), 123-130
- https://doi.org/10.4174/jkss.2013.84.2.123
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).Keywords
This publication has 24 references indexed in Scilit:
- Long-term outcomes after laparoscopy-assisted gastrectomy for advanced gastric cancer: a large-scale multicenter retrospective studySurgical Endoscopy, 2011
- Long-term oncologic outcomes of 714 consecutive laparoscopic gastrectomies for gastric cancer: results from the 7-year experience of a single instituteSurgical Endoscopy, 2011
- Morbidity and Mortality of Laparoscopic Gastrectomy Versus Open Gastrectomy for Gastric CancerAnnals of Surgery, 2010
- Multicentre study of the safety of laparoscopic subtotal gastrectomy for gastric cancer in the elderlyBritish Journal of Surgery, 2009
- Laparoscopic Versus Open Subtotal Gastrectomy for Adenocarcinoma: A Case–Control StudyAnnals of Surgical Oncology, 2009
- The impact of a high body mass index on laparoscopy assisted gastrectomy for gastric cancerSurgical Endoscopy, 2009
- Risk Factors Associated with Complication Following Laparoscopy-Assisted Gastrectomy for Gastric Cancer: A Large-Scale Korean Multicenter StudyAnnals of Surgical Oncology, 2008
- A Multicenter Study on Oncologic Outcome of Laparoscopic Gastrectomy for Early Cancer in JapanAnnals of Surgery, 2007
- T lymphocyte subsets and Th1/Th2 balance after laparoscopy-assisted distal gastrectomySurgical Endoscopy, 2003
- Quality of life research within the EORTC—the EORTC QLQ-C30European Journal Of Cancer, 2002