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 |
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| 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 
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| PRINCIPLE INVESTIGATOR |
Hyung-Ho Kim (Seoul National University College of Medicine) e-mail: lapakh2@gmail.com |
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| CHRONOLOGY | 2004.07 | KLASS foundation |
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| 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 |
1. Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. 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. doi: 10.1097/SLA.0000000000001346. PMID: 26352529.
2. Kim HH, Han SU, Kim MC, Kim W, Lee HJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Hyung WJ; Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group. Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-term Survival Among Patients With Stage I Gastric Cancer: The KLASS-01 Randomized Clinical Trial. JAMA Oncol. 2019 Apr 1;5(4):506-513. doi: 10.1001/jamaoncol.2018.6727. PMID: 30730546; PMCID: PMC6459124. |
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