Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-25 @ 1:13 PM
Study NCT ID:
NCT04889859
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2021-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy
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'}], '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': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-12', 'studyFirstSubmitDate': '2021-05-09', 'studyFirstSubmitQcDate': '2021-05-12', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diabetes remission rate (%)', 'timeFrame': '6 months', 'description': 'rate of the patients with HbA1c \\< 6.5% without medication'}], 'secondaryOutcomes': [{'measure': 'delta HbA1c (%)', 'timeFrame': '6 months', 'description': 'difference of preoperative HbA1c and postoperative HbA1c'}, {'measure': 'changes in body mass index (BMI, kg/m2)', 'timeFrame': 'up to 6 months', 'description': 'difference of preoperative BMI and postoperative BMI'}, {'measure': 'changes in body fat mass (kg)', 'timeFrame': 'up to 6 months', 'description': 'difference in body fat mass measured by bioimpedance analysis'}, {'measure': 'changes in lean body mass (kg)', 'timeFrame': 'up to 6 months', 'description': 'difference in lean body mass measured by bioimpedance analysis'}, {'measure': 'changes in blood glucose and insulin concentration', 'timeFrame': 'up to 6 months', 'description': 'changes in dynamic blood glucose and insulin levels up to 2 hours after 75g - oral glucose challenge'}, {'measure': 'changes in dynamic incretin hormone secretion', 'timeFrame': 'up to 6 months', 'description': 'changes in dynamic GLP-1 and GIP secretion up to 2 hours after 75g oral glucose challenge'}, {'measure': 'changes in gut microbiota', 'timeFrame': 'before & at 3 months after surgery', 'description': 'gut microbiota analysis from the fecal samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['incretin'], 'conditions': ['Stomach Neoplasm', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized controlled trial to investigate the impact of a long biliopancreatic limb of Roux-en-Y reconstruction on diabetes control in patients with concurrent type 2 diabetes and gastric cancer', 'detailedDescription': 'The present study aimed to compare the changes in glucose metabolism and incretin hormone responses following long-limb bypass Roux-en-Y reconstruction with different biliopancreatic limb lengths after distal gastrectomy in gastric cancer patients with type 2 diabetes. This is a prospective, single-center, randomized controlled trial. Patients diagnosed with stage I gastric cancer and type 2 diabetes are eligible for the present study. Patients who will undergo laparoscopic distal gastrectomy for cancer located at the lower two-thirds of the stomach will only be included.\n\nThe reconstruction method will be randomly assigned among long-Roux limb Roux-en-Y (with 100 cm-long Roux limb \\& 50cm-long biliopancreatic limb) or long-biliopancreatic limb Roux-en-Y (with 50 cm-long Roux limb \\& 100cm-long biliopancreatic limb) reconstruction methods.\n\nAll the patients are subjected to a 75g-oral glucose tolerance test (OGTT) preoperatively, and at 3 months, 6 months postoperatively, and serum glucose, as well as incretin hormones, will be serially measured. Fecal samples will be obtained preoperatively and at 3 months after surgery for gut microbiota analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with type 2 diabetes as well as pathologically proven gastric cancer of clinical stage I according to the AJCC 8th edition\n* Those who are expected to undergo laparoscopic distal gastrectomy\n\nExclusion Criteria:\n\n1. baseline fasting C-peptide level \\< 1.0 ng/dL (who had the possibility of type 1 diabetes)\n2. previous radiotherapy or surgery at upper abdomen other than laparoscopic cholecystectomy\n3. other malignancies in recent 5 years\n4. vulnerable patients (pregnant women, those with cognitive impairment, etc)\n5. ECOG-PS ≥ 2\n6. participating in other clinical trials within 6 months'}, 'identificationModule': {'nctId': 'NCT04889859', 'briefTitle': 'Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Chilgok Hospital'}, 'officialTitle': 'Impact of the Length of Biliopancreatic Limb on Diabetes Associated With the Changes in Incretin Hormone and Gut Microbiota Following Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'KNUCH 2019-04-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'long RL group', 'description': 'long Roux limb Roux-en-Y reconstruction', 'interventionNames': ['Procedure: long Roux limb Roux-en-Y reconstruction']}, {'type': 'EXPERIMENTAL', 'label': 'long BPL group', 'description': 'long biliopancreatic limb Roux-en-Y reconstruction', 'interventionNames': ['Procedure: long biliopancreatic limb Roux-en-Y reconstruction']}], 'interventions': [{'name': 'long Roux limb Roux-en-Y reconstruction', 'type': 'PROCEDURE', 'description': 'After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Roux-en-Y reconstruction using 100 cm-long Roux limb and 50 cm-long biliopancreatic limb.', 'armGroupLabels': ['long RL group']}, {'name': 'long biliopancreatic limb Roux-en-Y reconstruction', 'type': 'PROCEDURE', 'description': 'After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Roux-en-Y reconstruction using 50 cm-long Roux limb and 100 cm-long biliopancreatic limb.', 'armGroupLabels': ['long BPL group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41404', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Chilgok Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Ji Yeon Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Chilgok Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyungpook National University Chilgok Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ji Yeon Park', 'investigatorFullName': 'Ji Yeon Park', 'investigatorAffiliation': 'Kyungpook National University Chilgok Hospital'}}}}