KLASS 01



ClinicalTrials.gov Identifier | NCT 00452751

FULL NAME Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for early gastric cancer
STUDY DESIGN Multicenter, Prospective, Phase III trial
Primary endpoint: 5 year disease free survival
19 surgeons from 17 centers
Retrospective cohort : 3284
Prospective cohort : 1416

PRINCIPLE
INVESTIGATOR
Hyung-Ho Kim (Seoul National University College of Medicine)
e-mail: lapakh2@gmail.com
CHRONOLOGY 2004.07 KLASS foundation
2006.01 KLASS 01 start
2007.04 Interim analysis (Morbidity and mortality analyzed)
2010.08 Final enrollment
2014.03 Long-term result of retrospective data
2015.09 Short-term outcomes of prospective data
2017.03 Anticipating long-term outcomes of prospective data
PUBLICATED
ARTICLES
Kim MC, Kim W, Kim HH, et al. Risk factors associated with complication following laparoscopy-assisted gastrectomy for gastric cancer: a large-scale korean multicenter study. Ann Surg Oncol. 2008 Oct;15(10):2692-700.

Kim W, Song KY, Lee HJ, et al. The impact of comorbidity on surgical outcomes in laparoscopy-assisted distal gastrectomy: a retrospective analysis of multicenter results. Ann Surg. 2008 Nov;248(5):793-9.

Song KY, Hyung WJ, Kim HH, et al. Is gastrectomy mandatory for all residual or recurrent gastric cancer following endoscopic resection? A large-scale Korean multi-center study. J Surg Oncol. 2008 Jul 1;98(1):6-10.

Cho GS, Kim W, Kim HH, et al. Multicentre study of the safety of laparoscopic subtotal gastrectomy for gastric cancer in the elderly. Br J Surg. 2009 Dec;96(12):1437-42.

Jeong GA, Cho GS, Kim HH, et al. Laparoscopy-assisted total gastrectomy for gastric cancer: a multicenter retrospective analysis. Surgery. 2009 Sep;146(3):469-74.

Lee HJ, Kim HH, Kim MC, et al. The impact of a high body mass index on laparoscopy assisted gastrectomy for gastric cancer. Surg Endosc. 2009 Nov;23(11):2473-9.

Kim HH, Hyung WJ, Cho GS, et al. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg 2010;251:417-20.

Song J, Lee HJ, Cho GS, et al. Recurrence following laparoscopy-assisted gastrectomy for gastric cancer: a multicenter retrospective analysis of 1,417 patients. Ann Surg Oncol. 2010 Jul;17(7):1777-86.

Park DJ, Han SU, Hyung WJ, et al. Long-term outcomes after laparoscopy-assisted gastrectomy for advanced gastric cancer: a large-scale multicenter retrospective study. Surg Endosc. 2012 Jun;26(6):1548-53.

Kim HH, Han SU, Kim MC, et al. Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01). J Korean Surg Soc 2013;84:123-30.

Kim HH, Han SU, Kim MC, et al. Long-term results of laparoscopic gastrectomy for gastric cancer: a large-scale case-control and case-matched Korean multicenter study. J Clin Oncol 2014;32:627-33.

Kim HH, Son SY, Ahn S, et al. Reply to M. Honda et al. J Clin Oncol. 2014 Oct 1;32(28):3201-2.

Kim W, Kim HH, Han SU, et al. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35.