Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT01361750
Status:
TERMINATED
Last Update Posted:
2020-03-31
First Post:
2011-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'higher occurrence of complication than expected for both groups', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-29', 'studyFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2011-05-26', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of nutritional status and quality of life before and after operation', 'timeFrame': 'before operation (baseline), 1 month, 6 month and 12 month after operation'}], 'secondaryOutcomes': [{'measure': 'change of serum markers and tissue inflammatory status before and after operation', 'timeFrame': 'before operation (baseline), 1 month, 6 month and 12 month after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Oesophageal Cancer']}, 'descriptionModule': {'briefSummary': 'This study is to investigate the effects of narrowed gastric tube on postoperative nutritional status and the quality of life in esophageal cancer patients treated with Ivor-Lewis esopagectomy in a 12-month follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* esophageal cancer (squamous and adenocarcinoma subtypes)\n* eligble for Ivor-Lowis esophagectomy\n* expected survival time longer than 12 months\n\nExclusion Criteria:\n\n* palliative resection(non-R0)\n* anastomosis leak\n* jejunum or colon transversum interponate'}, 'identificationModule': {'nctId': 'NCT01361750', 'briefTitle': 'The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy: A Randomized Control Trial and Physiological Study', 'orgStudyIdInfo': {'id': 'PKU-OES-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'gastirc tube group', 'description': 'conduit will be perfomed by narrowed gastric tube', 'interventionNames': ['Procedure: gastric tube']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'conduit will be traditional subtotal stomach without any surgical modification'}], 'interventions': [{'name': 'gastric tube', 'type': 'PROCEDURE', 'description': 'the stomach will be cut into a narrowed tube-shape conduit', 'armGroupLabels': ['gastirc tube group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University School of Oncology', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yue Yang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Health Science Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Thoracic Surgery II', 'investigatorFullName': 'Yang Yue', 'investigatorAffiliation': 'Peking University'}}}}