Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial
KLASS
Multi-institutional Prospective Randomized Trial on the Assessment of Laparoscopic Surgery for Gastric Cancer
1 other identifier
interventional
1,400
1 country
16
Brief Summary
The purpose of this study is to assess the usefulness of laparoscopic surgery for gastric cancer in comparison with open gastrectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 gastric-cancer
Started Feb 2006
Longer than P75 for phase_3 gastric-cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 26, 2007
CompletedFirst Posted
Study publicly available on registry
March 27, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedSeptember 21, 2010
September 1, 2010
March 26, 2007
September 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
Secondary Outcomes (5)
disease-free survival
morbidity and mortality
quality of life
inflammatory and immune response
cost-effectiveness
Interventions
Eligibility Criteria
You may qualify if:
- pathologically proven gastric adenocarcinoma
- age: 20 \~ 80 years
- preoperative stage: cT1N0M0, cT1N1M0, cT2aN0M0
- no history of other cancer
- no history of chemotherapy or radiotherapy
- written informed consent
You may not qualify if:
- ASA \>3
- combined resection
- total gastrectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Chungnam National University Hospital
Daejun, Chungcheongnam-do, South Korea
Chonbuk National University Hospital
Chonjoo, Jeollabuk-do, South Korea
Soonchunhyang University College of Medicine
Bucheon-si, 420-767, South Korea
Catholic University Holy Family Hospital
Bucheon-si, South Korea
Keimyung University College of Medicine
Daegu, 700-712, South Korea
Dong-A University College of Medicine
Pusan, 602-715, South Korea
Seoul National University Bundang Hospital
Seongnam, 463-707, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Yonsei University College of Medicine
Seoul, 120-752, South Korea
Catholic University Kangnam St. Mary's Hospital
Seoul, South Korea
Ewha Womans University Hospital
Seoul, South Korea
Kangnam Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Ajou University College of Medicine
Suwon, South Korea
St. Vincent's Hospital
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea
Related Publications (5)
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: 30730546DERIVEDKim 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: 26352529DERIVEDKim HH, Han SU, Kim MC, Hyung WJ, Kim W, Lee HJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. 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 Feb;84(2):123-30. doi: 10.4174/jkss.2013.84.2.123. Epub 2013 Jan 29.
PMID: 23396494DERIVEDKim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. 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 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.
PMID: 20160637DERIVEDKim MC, Kim W, Kim HH, Ryu SW, Ryu SY, Song KY, Lee HJ, Cho GS, Han SU, Hyung WJ; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. 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. doi: 10.1245/s10434-008-0075-z. Epub 2008 Jul 29.
PMID: 18663532DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyung-Ho Kim, MD, PhD
Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707, Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 26, 2007
First Posted
March 27, 2007
Study Start
February 1, 2006
Study Completion
May 1, 2014
Last Updated
September 21, 2010
Record last verified: 2010-09