Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-03 @ 8:02 PM
Study NCT ID:
NCT01528059
Status:
UNKNOWN
Last Update Posted:
2012-02-07
First Post:
2012-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Roux-en-Y Versus Billroth II Reconstruction After Subtotal Gastrectomy in Gastric Cancer Comorbid With Type II Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-06', 'studyFirstSubmitDate': '2012-02-02', 'studyFirstSubmitQcDate': '2012-02-06', 'lastUpdatePostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': '1 year after surgery', 'description': '1. Fasting and postprandial glycemic levels, HbA1C\n2. Number of anti-diabetic drugs\n3. Dosage of anti-diabetic drugs'}], 'secondaryOutcomes': [{'measure': 'Nutritional status assessment', 'timeFrame': '1 year after surgery', 'description': '1. Body mass index\n2. Anthropometric analysis\n3. Plasma concentrations of albumin, pre-albumin, transferrin,and CRP'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Gastric cancer', 'Gastric bypass'], 'conditions': ['Gastric Cancer', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Gastric bypass improves glycemic levels in type 2 diabetes. However, the efficacy may be varied by different gastric-small intestine reconstruction used in the procedure. There are reports that Roux en Y reconstruction may give a better result. The purpose of this study is to compare Roux en Y and Billroth II reconstruction in patients with gastric cancer comorbid with type 2 diabetes.', 'detailedDescription': 'Type 2 diabetes may cause severe complications such as nephropathy and retinopathy. Additionally, it is associated with increased risk for cardiovascular events and diseases. Surgical intervention with gastric bypass has been shown to attenuate glycemic levels in obese patient comorbid with type 2 diabetes. However, since gastric bypass is not a standard procedure, surgical protocol including stomach and small intestine reconstruction may be varied. The investigators and others have found that stomach and small intestine reconstruction may affect the efficacy of diabetic treatment. In this study, the investigators will compare the efficacy of Billroth II and Roux en Y reconstruction on glycemic control in stomach cancer patients with type 2 diabetes. Both Billroth II and Roux en Y are used in stomach-small intestine reconstruction after subtotal gastrectomy. No differences in postoperative outcomes and quality of life have been reported in Billroth II and Roux en Y reconstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with Type 2 diabetes\n2. Diagnosed with gastric cancer\n\nExclusion Criteria:\n\n1. Type 1 diabetes\n2. Unresectable cancers'}, 'identificationModule': {'nctId': 'NCT01528059', 'briefTitle': 'Roux-en-Y Versus Billroth II Reconstruction After Subtotal Gastrectomy in Gastric Cancer Comorbid With Type II Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Xiamen University'}, 'officialTitle': 'A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer Comorbid With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'DongFang'}, 'secondaryIdInfos': [{'id': 'FNSP2009Y0039', 'type': 'OTHER_GRANT', 'domain': 'Fujian Natural Science Project'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Billroth II', 'description': 'After stomach resection, the remnant stomach is connected to the jejunum.', 'interventionNames': ['Procedure: Stomach-small intestine reconstruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Roux en Y', 'description': 'After stomach resection, the remnant stomach is connected to the distal jejunum while duodenum and the proximal jejunum is reconnected to jejunum.', 'interventionNames': ['Procedure: Stomach-small intestine reconstruction']}], 'interventions': [{'name': 'Stomach-small intestine reconstruction', 'type': 'PROCEDURE', 'description': 'Billroth II or Roux en Y reconstruction will be performed after gastric resection in stomach patients co-morbid with type 2 diabetes', 'armGroupLabels': ['Billroth II', 'Roux en Y']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350025', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Wang, M.D', 'role': 'CONTACT', 'email': 'flyfishwang@hotmail.com', 'phone': '13805019453'}, {'name': 'ZhongDong Zhou, M.D', 'role': 'CONTACT', 'email': 'fzptwk@21cn.com', 'phone': '13705038043'}, {'name': 'Yu Wang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'DongFang Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Yu Wang, M.D', 'role': 'CONTACT', 'email': 'flyfishwang@hotmail.com', 'phone': '13805019453'}, {'name': 'Zhongdong Zhou, M.D', 'role': 'CONTACT', 'email': 'fzptwk@21cn.com', 'phone': '13705038043'}], 'overallOfficials': [{'name': 'Yu Wang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dongfang Hospital, Xiamen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'feng Zheng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'feng Zheng', 'investigatorAffiliation': 'Xiamen University'}}}}