Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:47 AM
Study NCT ID:
NCT02964806
Status:
COMPLETED
Last Update Posted:
2018-03-15
First Post:
2016-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055423', 'term': 'Diet, Ketogenic'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-13', 'studyFirstSubmitDate': '2016-11-13', 'studyFirstSubmitQcDate': '2016-11-13', 'lastUpdatePostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food Intake Rate(%) for postoperative diet', 'timeFrame': '3 days after the diet', 'description': 'Diet Intake Rate(%) will be examined by dietary satisfaction questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ketogen-based Therapeutic Diet', 'Pancreaticobiliary Cancer']}, 'descriptionModule': {'briefSummary': 'Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets for pancreaticobiliary cancer patients. The investigators expect that customized diets for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (age more than 19)\n* Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy\n* Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer\n\nExclusion Criteria:\n\n* Patient who denied clinical trial\n* Diabetes Mellitus(DM) patient with DM complication\n* Hyperlipidemia patient with vascular co-morbidity\n* Impaired renal function or renal failure (GFP\\<90%)'}, 'identificationModule': {'nctId': 'NCT02964806', 'briefTitle': 'Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2016-0799'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ordinary Diet', 'description': 'Ordinary Diet', 'interventionNames': ['Dietary Supplement: Ordinary Diet']}, {'type': 'OTHER', 'label': "Modified Atkin's Diet", 'description': "Modified Atkin's Diet", 'interventionNames': ["Dietary Supplement: Modified Atkin's Diet"]}, {'type': 'OTHER', 'label': 'Ketogenic Diet', 'description': 'Ketogenic Diet', 'interventionNames': ['Dietary Supplement: Ketogenic Diet']}], 'interventions': [{'name': 'Ordinary Diet', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Ordinary Diet']}, {'name': "Modified Atkin's Diet", 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ["Modified Atkin's Diet"]}, {'name': 'Ketogenic Diet', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Ketogenic Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}