Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-25 @ 4:27 AM
Study NCT ID:
NCT00677456
Status:
UNKNOWN
Last Update Posted:
2008-05-14
First Post:
2008-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Four Reconstructions After Total Gastrectomy
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-05-12', 'studyFirstSubmitDate': '2008-05-12', 'studyFirstSubmitQcDate': '2008-05-12', 'lastUpdatePostDateStruct': {'date': '2008-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients should live for 6 months at least, and with acceptable life quality', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'There are significant differences among life qualities of the four reconstructions', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'total gastrectomy', 'reconstruction', 'life quality'], 'conditions': ['Gastric Cancer', 'Nutrition']}, 'descriptionModule': {'briefSummary': 'There are four capital reconstructions after total gastrectomy which is widely used in China. Life quality is the only standard to evaluate postoperative results of different reconstructions. In order to determine the best reconstruction after total gastrectomy, we designed this study to compare life qualities of four reconstructions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients should be younger than 80 years old with adequate renal, pulmonary, and heart functions.\n\nExclusion Criteria:\n\n* death or other reason which cause information discontinue'}, 'identificationModule': {'nctId': 'NCT00677456', 'briefTitle': 'Evaluation of Four Reconstructions After Total Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy', 'orgStudyIdInfo': {'id': 'TDH00431'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Patients will receive R-Y reconstruction after total gastrectomy as intervention', 'interventionNames': ['Procedure: R-Y reconstruction after total gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Patients will receive P-Y reconstruction after total gastrectomy as intervention', 'interventionNames': ['Procedure: P-Y reconstruction after total gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Patients will receive Pouch reconstruction after total gastrectomy as intervention.', 'interventionNames': ['Procedure: Pouch reconstruction after total gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Patients will receive P-I reconstruction after total gastrectomy as intervention.', 'interventionNames': ['Procedure: P-I reconstruction after total gastrectomy']}], 'interventions': [{'name': 'R-Y reconstruction after total gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['R-Y reconstruction'], 'description': 'Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.', 'armGroupLabels': ['1']}, {'name': 'P-Y reconstruction after total gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['P-Y reconstruction'], 'description': 'Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the P-Y.', 'armGroupLabels': ['2']}, {'name': 'Pouch reconstruction after total gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['Pouch reconstruction'], 'description': 'Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border, the distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.', 'armGroupLabels': ['3']}, {'name': 'P-I reconstruction after total gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['P-I reconstruction'], 'description': 'Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels.To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border,The pouch was 20 cm long, with a 10-cm jejunal loop with the P-I.', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710038', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'GuoQiang Bao, doctor', 'role': 'CONTACT', 'email': 'guoqiangbao@163.com', 'phone': '86-029-8477-7731'}, {'name': 'JiKai Yin, doctor', 'role': 'CONTACT', 'email': 'yjkfmmuu@hotmail.com', 'phone': '86-029-8477-7732'}, {'name': 'XianLi He, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'GuoQiang Bao, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'JiKai Yin, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of general surgery,Tangdu hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Xian Li He, doctor', 'role': 'CONTACT', 'email': 'wanghe@fmmu.edu.cn', 'phone': '86-029-8477-7432'}, {'name': 'Guo Qiang Bao, doctor', 'role': 'CONTACT', 'email': 'guoqiangbao@163.com', 'phone': '86-029-8477-7731'}], 'overallOfficials': [{'name': 'XianLi He, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of general surgery, Tangdu hospital of fourth military medical university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'He XianLi/director of department of Gastrointestinal Surgery, Tang-Du Hospital', 'oldOrganization': 'Department of Gastrointestinal Surgery, Tang-Du Hospital'}}}}