Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-28 @ 10:10 AM
Study NCT ID:
NCT00746161
Status:
COMPLETED
Last Update Posted:
2008-09-04
First Post:
2008-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer
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': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-03', 'studyFirstSubmitDate': '2008-09-02', 'studyFirstSubmitQcDate': '2008-09-02', 'lastUpdatePostDateStruct': {'date': '2008-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The %body weight ratio', 'timeFrame': '12 months after operation'}], 'secondaryOutcomes': [{'measure': 'preoperative complication, PNI and QOL score', 'timeFrame': 'within one month, and 3 and 12months after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['total gastrectomy', 'double tract reconstruction', 'gastric cancer', 'Total gastrectomy in patients with gastric cancer'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '19548028', 'type': 'DERIVED', 'citation': 'Iwahashi M, Nakamori M, Nakamura M, Naka T, Ojima T, Iida T, Katsuda M, Ueda K, Yamaue H. Evaluation of double tract reconstruction after total gastrectomy in patients with gastric cancer: prospective randomized controlled trial. World J Surg. 2009 Sep;33(9):1882-8. doi: 10.1007/s00268-009-0109-0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method', 'detailedDescription': 'Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT reconstruction after total gastrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2\n* Age 80 years or younger\n* No distant metastasis\n\nExclusion Criteria:\n\n* Carcinoma in the remnant stomach\n* Stage intravenous (IV)\n* History of laparotomy\n* History of serious heart disease\n* Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more\n* Absence of informed consent'}, 'identificationModule': {'nctId': 'NCT00746161', 'briefTitle': 'Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wakayama Medical University'}, 'officialTitle': 'A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer', 'orgStudyIdInfo': {'id': 'WMU-GC02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Roux-en-Y', 'interventionNames': ['Procedure: Reconstruction after total gastrectomy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'double tract reconstruction', 'interventionNames': ['Procedure: Reconstruction after total gastrectomy']}], 'interventions': [{'name': 'Reconstruction after total gastrectomy', 'type': 'PROCEDURE', 'description': 'Roux-en-Y', 'armGroupLabels': ['1']}, {'name': 'Reconstruction after total gastrectomy', 'type': 'PROCEDURE', 'description': 'double tract reconstruction', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '641-8510', 'city': 'Wakayama', 'state': 'Wakayama', 'country': 'Japan', 'facility': 'Second Department of Surgery, Wakayama Medical University', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'overallOfficials': [{'name': 'Makoto Iwahashi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Department of Surgery, Wakayama Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wakayama Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Second Department of Surgery', 'oldOrganization': 'Wakayama Medical University'}}}}