Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-29 @ 1:34 AM
Study NCT ID:
NCT04704895
Status:
UNKNOWN
Last Update Posted:
2021-01-12
First Post:
2020-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010289', 'term': 'Parenteral Nutrition, Total'}, {'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'id': 'D010288', 'term': 'Parenteral Nutrition'}, {'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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-10', 'studyFirstSubmitDate': '2020-11-28', 'studyFirstSubmitQcDate': '2021-01-10', 'lastUpdatePostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of patients with one or more postoperative complications (time range: 90 days) was observed, and data were recorded during the hospital stay (expected average of 3 weeks) and during control visits 3 months postoperatively.', 'timeFrame': '3month', 'description': 'The percentage of patients with one or more postoperative complications (time range: 90 days) was observed, and data were recorded during the hospital stay (expected average of 3 weeks) and during control visits 3 months postoperatively.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enteral Nutrition']}, 'descriptionModule': {'briefSummary': 'To prove that early enteral nutrition after pancreaticoduodenal operation is of great significance to improve the immune response, reduce the incidence of postoperative infection and other related complications, and shorten the length of hospital stay', 'detailedDescription': 'Arm A: Total parenteral nutrition. TPN also started from POD 1 and was delivered through a central venous catheter. Target energy of 1.5 amino acids/kg/day reached 30 kcal/kg/day.\n\nArm B: NJEEN was defined as providing at least 50% of the nutritional requirements through the nasojejunal tube prior to the 5th day after surgery (POD) and having no parenteral nutrition for 72 h or more.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 80 years old, gender is not limited;\n* All patients underwent pancreaticoduodenectomy;\n* ECOG 0 \\~ 2 for physical condition score;\n* Imaging examination found pancreatic head, periampullary space, no distant metastasis and ascites;\n* No bone marrow dysfunction;\n* Those without obvious surgical contraindications;\n* Expected postoperative survival ≥3 months;\n* The study visit plan and other programme requirements are now available;\n* Voluntary participation and signing of informed consent.\n\nExclusion Criteria:\n\n* Patients with stage II and IV periampullary carcinoma of head of pancreas and periampullary carcinoma;\n* Active infected persons;\n* Distant metastasis or ascites were found in imaging examination;\n* Patients with serious impairment of heart, liver and kidney function (grade 3 to 4, ALT and/or AST more than 3 times the normal upper limit, Cr more than the normal upper limit);\n* patients with other malignant tumors or blood diseases;\n* Pregnancy, planned pregnancy and lactation female patients (urine HCG \\>02500 iu /L, diagnosed as early pregnancy);'}, 'identificationModule': {'nctId': 'NCT04704895', 'briefTitle': 'Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Prospective RCT Study of Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy', 'orgStudyIdInfo': {'id': 'CSPAC-32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A: Total parenteral nutrition', 'description': 'Total parenteral nutrition, TPN also starts from POD 1 and is delivered through a central venous catheter, with a target energy of 1.5 amino acids/kg/day reaching 30 kcal/kg/day', 'interventionNames': ['Dietary Supplement: Total parenteral nutrition']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Enteral nutrition', 'description': 'NJEEN was defined as providing at least 50% of the nutritional requirements through the nasojejunal tube prior to the 5th day after surgery (POD) and having no parenteral nutrition for 72 hours or more.', 'interventionNames': ['Dietary Supplement: Enteral nutrition']}], 'interventions': [{'name': 'Total parenteral nutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Total parenteral nutrition, TPN also starts from POD 1 and is delivered through a central venous catheter, with a target energy of 1.5 amino acids/kg/day reaching 30 kcal/kg/day', 'armGroupLabels': ['Arm A: Total parenteral nutrition']}, {'name': 'Enteral nutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'NJEEN was defined as providing at least 50% of the nutritional requirements through the nasojejunal tube prior to the 5th day after surgery (POD) and having no parenteral nutrition for 72 hours or more.', 'armGroupLabels': ['Arm B: Enteral nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Sahnghai', 'country': 'China', 'contacts': [{'name': 'Xianjun Yu, Phd', 'role': 'CONTACT'}], 'facility': 'Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xianjun Yu, Phd', 'role': 'CONTACT', 'email': 'yuxianjun@fudanpci.org', 'phone': '18019112906'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xian-Jun Yu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'President of Pancreatic Cancer Institute', 'investigatorFullName': 'Xian-Jun Yu', 'investigatorAffiliation': 'Fudan University'}}}}