Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial
NCT ID: NCT00452751
Last Updated: 2010-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1400 participants
INTERVENTIONAL
2006-02-28
2014-05-31
Brief Summary
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Detailed Description
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Korean Laparoscopic Gastrointestinal Surgery Study Group, therefore, proposed a multi-institutional prospective randomized trial on comparing laparoscopy-assisted versus open distal gastrectomy for gastric cancer (KLASS Trial) after the feasibility and validity of these procedures had been evaluated by analyzing retrospective multi-center large series.
This KLASS trial is supported by a grant for 2005 from the National R\&D Program for Cancer Control, Ministry of Health \& Welfare, Republic of Korea. Nine surgeons from 9 centers are participating in this trial. All the participants performed more than 50 cases of open and laparoscopic gastrectomies, respectively and their institutes had more than 80 cases of gastric cancer surgeries per year. Primary endpoint of this trial is to elucidate that there is no difference of overall and disease-free survivals between laparoscopic and open groups. The KLASS trial consists of 5 major subjects: comparison of 5-year overall and disease-free survivals, standardization of preoperative diagnosis, assessment of the quality of life, evaluation of postoperative inflammatory response and immune function, and cost-effectiveness. The KLASS trial will be able to validate and verify laparoscopic gastric cancer surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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laparoscopy-assisted distal gastrectomy
open distal gastrectomy
Eligibility Criteria
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Inclusion Criteria
2. age: 20 \~ 80 years
3. preoperative stage: cT1N0M0, cT1N1M0, cT2aN0M0
4. no history of other cancer
5. no history of chemotherapy or radiotherapy
6. written informed consent
Exclusion Criteria
2. combined resection
3. total gastrectomy
20 Years
80 Years
ALL
No
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Principal Investigators
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Hyung-Ho Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707, Korea
Locations
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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, , South Korea
Catholic University Holy Family Hospital
Bucheon-si, , South Korea
Keimyung University College of Medicine
Daegu, , South Korea
Dong-A University College of Medicine
Pusan, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University College of Medicine
Seoul, , 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
Countries
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Central Contacts
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Facility Contacts
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Sang Il Lee, MD
Role: primary
Joo Ho Lee, MD
Role: primary
Seung Ho Choi, MD
Role: primary
Tae Sung Sohn, MD
Role: primary
Hyung Min Jin, MD
Role: primary
References
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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.
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.
Kim 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.
Kim 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.
Kim 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.
Other Identifiers
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0520310-2
Identifier Type: -
Identifier Source: org_study_id