Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT00452751
Status:
UNKNOWN
Last Update Posted:
2010-09-21
First Post:
2007-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-20', 'studyFirstSubmitDate': '2007-03-26', 'studyFirstSubmitQcDate': '2007-03-26', 'lastUpdatePostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival'}], 'secondaryOutcomes': [{'measure': 'disease-free survival'}, {'measure': 'morbidity and mortality'}, {'measure': 'quality of life'}, {'measure': 'inflammatory and immune response'}, {'measure': 'cost-effectiveness'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastric cancer', 'laparoscopic surgery', 'survival', 'preoperative staging', 'morbidity', 'quality of life', 'acute inflammatory reaction', 'cost'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '30730546', 'type': 'DERIVED', 'citation': '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': '26352529', 'type': 'DERIVED', 'citation': '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': '23396494', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '20160637', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '18663532', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the usefulness of laparoscopic surgery for gastric cancer in comparison with open gastrectomy.', 'detailedDescription': 'Recently, in technical aspects, almost all kinds of open gastric cancer surgeries can be reproduced laparoscopically. However, many controversies exist due to no evidence and no long-term results. There was no prospective multi-center large-scale randomized controlled trial in the world on the long-term outcome of laparoscopic gastric cancer surgery.\n\nKorean 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pathologically proven gastric adenocarcinoma\n2. age: 20 \\~ 80 years\n3. preoperative stage: cT1N0M0, cT1N1M0, cT2aN0M0\n4. no history of other cancer\n5. no history of chemotherapy or radiotherapy\n6. written informed consent\n\nExclusion Criteria:\n\n1. ASA \\>3\n2. combined resection\n3. total gastrectomy'}, 'identificationModule': {'nctId': 'NCT00452751', 'acronym': 'KLASS', 'briefTitle': 'Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Multi-institutional Prospective Randomized Trial on the Assessment of Laparoscopic Surgery for Gastric Cancer', 'orgStudyIdInfo': {'id': '0520310-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'laparoscopy-assisted distal gastrectomy', 'type': 'PROCEDURE'}, {'name': 'open distal gastrectomy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daejun', 'state': 'Chungcheongnam-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Il Lee, MD', 'role': 'CONTACT'}, {'name': 'Sang IL Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chungnam National University Hospital'}, {'city': 'Chonjoo', 'state': 'Jeollabuk-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chan Young Kim, MD', 'role': 'CONTACT', 'email': 'happyhill@chonbuk.ac.kr'}, {'name': 'Chan Young Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chonbuk National University Hospital'}, {'zip': '420-767', 'city': 'Bucheon-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Gyu Seok Cho, MD, PhD', 'role': 'CONTACT', 'email': 'gschogs@schbc.ac.kr', 'phone': '82-32-621-5114'}, {'name': 'Gyu Seok Cho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soonchunhyang University College of Medicine', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Bucheon-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Wook Kim, MD, PhD', 'role': 'CONTACT', 'email': 'kimwook@catholic.ac.kr', 'phone': '82-32-340-2114'}, {'name': 'Wook Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Catholic University Holy Family Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '700-712', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Wan Ryu, MD, PhD', 'role': 'CONTACT', 'email': 'gsman@dsmc.or.kr', 'phone': '82-53-250-7114'}, {'name': 'Seung-Wan Ryu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Keimyung University College of Medicine', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '602-715', 'city': 'Pusan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Min Chan Kim, MD, PhD', 'role': 'CONTACT', 'email': 'mckim@donga.ac.kr', 'phone': '82-51-240-2000'}, {'name': 'Min Chan Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dong-A University College of Medicine', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'zip': '463-707', 'city': 'Seongnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyung-Ho Kim, MD, PhD', 'role': 'CONTACT', 'email': 'hhkim@snubh.org', 'phone': '82-31-787-7095'}, {'name': 'Hyung-Ho Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Do Joong Park, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyuk-Joon Lee, MD, PhD', 'role': 'CONTACT', 'email': 'appe98@snu.ac.kr', 'phone': '82-2-2072-1957'}, {'name': 'Hyuk-Joon Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Han Kwang Yang, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Woo Jin Hyung, MD, PhD', 'role': 'CONTACT', 'email': 'wjhyung@yumc.yonsei.ac.kr', 'phone': '82-2-2227-0114'}, {'name': 'Woo Jin Hyung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyo Young Song, MD, PhD', 'role': 'CONTACT', 'email': 'skygs@catholic.ac.kr', 'phone': '82-2-590-1114'}, {'name': 'Kyo Young Song, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Catholic University Kangnam St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joo Ho Lee, MD', 'role': 'CONTACT'}, {'name': 'Joo Ho Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ewha Womans University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung Ho Choi, MD', 'role': 'CONTACT'}, {'name': 'Seung Ho Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Tae Sung Sohn, MD', 'role': 'CONTACT'}, {'name': 'Tae Sung Sohn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-Uk Han, MD, PhD', 'role': 'CONTACT', 'email': 'hansu@ajou.ac.kr', 'phone': '82-31-219-5114'}, {'name': 'Sang-Uk Han, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ajou University College of Medicine', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Suwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyung Min Jin, MD', 'role': 'CONTACT'}, {'name': 'Hyung Min Jin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Ulsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyu Yeol Kim, MD', 'role': 'CONTACT', 'email': 'kim9107798@dreamwiz.com'}, {'name': 'Kyu Yeol Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'centralContacts': [{'name': 'Hyung-Ho Kim, MD, PhD', 'role': 'CONTACT', 'email': 'hhkim@snubh.org', 'phone': '82-31-787-7095'}], 'overallOfficials': [{'name': 'Hyung-Ho Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}}}}