Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-08 @ 3:26 AM
Study NCT ID:
NCT01637350
Status:
UNKNOWN
Last Update Posted:
2016-02-17
First Post:
2012-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digestive Tract Reconstruction After Gastrectomy of Gastric Cancer With Type 2 Diabetes
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-14', 'studyFirstSubmitDate': '2012-07-06', 'studyFirstSubmitQcDate': '2012-07-10', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Different digestive tract reconstruction will affect the blood glucose level of gastric cancer with type 2 diabetes. Subtotal gastrectomy with Billroth II reconstruction and total gastrectomy with Roux-en-Y reconstruction may help to improve glycaemic control which includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C -peptide and body weight of gastric cancer patients with type 2 diabetes.', 'detailedDescription': 'Different digestive tract reconstruction will affect the blood glucose level of gastric cancer with type 2 diabetes. Subtotal gastrectomy with Billroth II reconstruction and total gastrectomy with Roux-en-Y reconstruction may help to improve glycaemic control which includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C -peptide and body weight of gastric cancer patients with type 2 diabetes.\n\nThe investigators will observed fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C -peptide and body weight of the patients preoperation, 14 days postoperation 3 month and 6month postoperation. The investigators will observed the effect of blood glucose to different digestive tract reconstruction after gastrectomy of gastric cancer with type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'gastric cancer with type 2 diabetes,18\\~75 years old,without serious underlying diseases', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-75 years old,gastric cancer ,can be performed operation\n2. with type 2 diabetes,fasting blood glucose \\> 6.1mmol/L\n3. without serious underlying diseases which may affect the metabolism and nutrient uptake\n4. without serious underlying diseases which may affect anesthesia and operation\n5. can be performed subtotal or total gastrectomy, predicted survival period \\> 6months\n6. no other abdominal operation\n7. preoperation consultation\n8. informed consent\n\nExclusion Criteria:\n\n1. recurrent,metastasis or die\n2. patient requests for quit\n3. pregnancy'}, 'identificationModule': {'nctId': 'NCT01637350', 'briefTitle': 'Digestive Tract Reconstruction After Gastrectomy of Gastric Cancer With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'The Effect of Blood Glucose to Different Digestive Tract Reconstruction After Gastrectomy of Gastric Cancer With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'CIH-WXN-201205001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subtotal gastrectomy , BillrothⅠ', 'interventionNames': ['Procedure: digestive tract reconstruction']}, {'label': 'Subtotal gastrectomy , BillrothⅡ', 'interventionNames': ['Procedure: digestive tract reconstruction']}, {'label': 'total gastrectomy, jejunal interposition', 'interventionNames': ['Procedure: digestive tract reconstruction']}, {'label': 'total gastrectomy , Roux-en-Y', 'interventionNames': ['Procedure: digestive tract reconstruction']}], 'interventions': [{'name': 'digestive tract reconstruction', 'type': 'PROCEDURE', 'otherNames': ['no other names'], 'description': 'Subtotal gastrectomy with BillrothⅠ or BillrothⅡ, total gastrectomy with jejunal interposition or Roux-en-Y reconstruction', 'armGroupLabels': ['Subtotal gastrectomy , BillrothⅠ', 'Subtotal gastrectomy , BillrothⅡ', 'total gastrectomy , Roux-en-Y', 'total gastrectomy, jejunal interposition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Zhao Yan, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tianjin Medical University Cancer Institute and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}