Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT02311595
Status:
UNKNOWN
Last Update Posted:
2014-12-08
First Post:
2014-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 67}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-05', 'studyFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2014-12-05', 'lastUpdatePostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping)', 'timeFrame': '1 month after enrollment of the patients', 'description': 'Compliance rate : Cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping'}]}, 'conditionsModule': {'keywords': ['gastric cancer', 'laparoscope'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '17705092', 'type': 'BACKGROUND', 'citation': 'Lee JH, Kim YW, Ryu KW, Lee JR, Kim CG, Choi IJ, Kook MC, Nam BH, Bae JM. A phase-II clinical trial of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer patients. Ann Surg Oncol. 2007 Nov;14(11):3148-53. doi: 10.1245/s10434-007-9446-0. Epub 2007 Aug 20.'}, {'pmid': '25227307', 'type': 'BACKGROUND', 'citation': 'Kim SM, Lee JH, Lee SH, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S. Techniques of reduced PRT laparoscopy-assisted distal gastrectomy (duet LADG). Ann Surg Oncol. 2015 Mar;22(3):793. doi: 10.1245/s10434-014-4087-6. Epub 2014 Sep 17.'}, {'pmid': '10089184', 'type': 'BACKGROUND', 'citation': 'Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I, Meyer S, Plukker JT, Van Elk P, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H; Dutch Gastric Cancer Group. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999 Mar 25;340(12):908-14. doi: 10.1056/NEJM199903253401202.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if reduced port totally laparoscopic distal gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological feasible.\n\n67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced port totally laparoscopic distal gastrectomy.\n\nThe primary end point of this study is to measure compliance rate with pathology report and compare with previous compliance rate data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed adenocarcinoma of the stomach\n* Eastern Cooperative Oncology Group Eastern Cooperative Oncology Group performance status 0-1,\n* signed informed consent\n* location of the primary tumor in the antrum, angle and lower body\n* no evidence of distant metastasis or invasion to adjacent organs or serosal infiltration\n\nExclusion Criteria:\n\n* metastatic disease\n* previous history of malignancy in any organ\n* any co-morbidity obviating major surgery'}, 'identificationModule': {'nctId': 'NCT02311595', 'briefTitle': 'A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer Patients', 'orgStudyIdInfo': {'id': '2014-10-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'reduced port', 'description': 'gastric cancer patients go through reduced port laparoscopic distal gastrectomy with D2 lymph node dissection', 'interventionNames': ['Procedure: reduced port laparoscopic distal gastrectomy']}], 'interventions': [{'name': 'reduced port laparoscopic distal gastrectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['reduced port']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jun Ho Lee, M.D. ph.D', 'role': 'CONTACT', 'email': 'gsjunholee@gmail.com', 'phone': '82-2-3410-3463'}, {'name': 'Jieun Kim, M.D.', 'role': 'CONTACT', 'email': 'wldmsld.kim@samsung.com', 'phone': '82-2-3410-1735'}], 'overallOfficials': [{'name': 'Jun Ho Lee, M.D. ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}