Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-01 @ 1:31 PM
Study NCT ID:
NCT01778166
Status:
UNKNOWN
Last Update Posted:
2013-01-31
First Post:
2013-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastrointestinal Postoperative Early Enteral Nutrition: Immuno-enhanced Versus Standard Early Enteral Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-30', 'studyFirstSubmitDate': '2013-01-25', 'studyFirstSubmitQcDate': '2013-01-28', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to tolerate IEEN/SEEN', 'timeFrame': '30 days after operation'}], 'secondaryOutcomes': [{'measure': 'Overall morbidity rate of IEEN/SEEN', 'timeFrame': '60 days after operation'}, {'measure': 'Mortality rate of IEEN/SEEN after operation', 'timeFrame': '60 days after operation'}, {'measure': 'Energy metabolism', 'timeFrame': '10 days after operation'}, {'measure': 'Time to the first postoperative adjuvant chemotherapy', 'timeFrame': '30 days after operation'}, {'measure': 'Nutritional status in postoperative day1and 7 of IEEN/SEEN', 'timeFrame': '7 days after operation'}, {'measure': 'Immune function in postoperative day 1 and 7', 'timeFrame': '7 days after operation'}, {'measure': 'Postoperative hospital stay length', 'timeFrame': '60 days after operation'}, {'measure': 'Rehospitalization rate', 'timeFrame': '30 days after discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Early enteral nutrition', 'Laparoscopic gastrointestinal surgery', 'Immuno-enhanced nutrition'], 'conditions': ['Gastrointestinal Malignant']}, 'referencesModule': {'references': [{'pmid': '21628607', 'type': 'BACKGROUND', 'citation': 'Osland E, Yunus RM, Khan S, Memon MA. Early versus traditional postoperative feeding in patients undergoing resectional gastrointestinal surgery: a meta-analysis. JPEN J Parenter Enteral Nutr. 2011 Jul;35(4):473-87. doi: 10.1177/0148607110385698. Epub 2011 May 31.'}, {'pmid': '22788925', 'type': 'BACKGROUND', 'citation': 'Liu H, Ling W, Shen ZY, Jin X, Cao H. Clinical application of immune-enhanced enteral nutrition in patients with advanced gastric cancer after total gastrectomy. J Dig Dis. 2012 Aug;13(8):401-6. doi: 10.1111/j.1751-2980.2012.00596.x.'}, {'pmid': '21058198', 'type': 'BACKGROUND', 'citation': 'Felekis D, Eleftheriadou A, Papadakos G, Bosinakou I, Ferekidou E, Kandiloros D, Katsaragakis S, Charalabopoulos K, Manolopoulos L. Effect of perioperative immuno-enhanced enteral nutrition on inflammatory response, nutritional status, and outcomes in head and neck cancer patients undergoing major surgery. Nutr Cancer. 2010;62(8):1105-12. doi: 10.1080/01635581.2010.494336.'}]}, 'descriptionModule': {'briefSummary': 'Patients with gastrointestinal(GI) malignancy usually suffer from malnutrition and suppressed immune function, which might be worsened by major elective surgery.Enteral nutrition has been emphasized for patients with GI malignancy during the perioperative period to accelerate bowel function recovery, and improve nitrogen balance and immune response while reducing postoperative complications and hospitalization time.Early enteral nutrition(EEN) can promote the postoperative recovery of GI function and has been considered to have other advantages such as the reduction of medical cost and maintenance of intestinal barrier function. Immunonutrition containing special compounds like omega-3-unsaturated fatty acids has been put forward to modulate the immune response and improve the immune function in patients with cancer, which may have an better effect on the immune system than standard enteral nutrition. However, studies on immuno-enhanced early enteral nutrition after a resectable GI malignancy surgery are scarce.\n\nThe aim of this study was to determine whether immuno-enhanced early enteral nutrition(IEEN) is more effective than standard early enteral nutrition(SEEN) on nutritional status, immune function, surgical outcomes,time to adjuvant chemotherapy and days of hospitalization after laparoscopic GI surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Resectable gastric cancer by laparoscope\n* Resectable colorectal cancer laparoscope\n* Resectable gastrointestinal interstitialoma by laparoscope\n\nExclusion Criteria:\n\n* Locally unresectable tumor\n* Metastatic tumor\n* Preoperative total parenteral or enteral nutrition\n* Lack of the patient's consent for the trial participation\n* Previous gastrointestinal resection"}, 'identificationModule': {'nctId': 'NCT01778166', 'acronym': 'ISEEN', 'briefTitle': 'Gastrointestinal Postoperative Early Enteral Nutrition: Immuno-enhanced Versus Standard Early Enteral Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'Immuno-enhanced Versus Standard Early Enteral Nutrition Use in Gastrointestinal Postoperative Patients', 'orgStudyIdInfo': {'id': 'ISEEN001'}, 'secondaryIdInfos': [{'id': 'ISEEN', 'type': 'REGISTRY', 'domain': 'ISEEN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard early enteral nutrition', 'description': 'There would be 100 patients in this group', 'interventionNames': ['Drug: Standard early enteral nutrition']}, {'type': 'EXPERIMENTAL', 'label': 'Immuno-enhanced early enteral nutrition', 'description': 'There would 100 patients in this group', 'interventionNames': ['Drug: Immuno-enhanced']}], 'interventions': [{'name': 'Immuno-enhanced', 'type': 'DRUG', 'description': 'Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C enteral nutrition fluid concerning omega-3-unsaturated fatty acids 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube', 'armGroupLabels': ['Immuno-enhanced early enteral nutrition']}, {'name': 'Standard early enteral nutrition', 'type': 'DRUG', 'description': 'Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C standard enteral nutrition fluid 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube', 'armGroupLabels': ['Standard early enteral nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Danhua Yao, MD/PhD', 'role': 'CONTACT', 'phone': '8602580860037'}, {'name': 'Danhua Yao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jinling Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Danhua Yao, MD/PhD', 'role': 'CONTACT', 'email': 'yaodh87@gmail.com', 'phone': '8602580860961'}, {'name': 'Yousheng Li, MD/PhD', 'role': 'CONTACT', 'email': 'liys@medmail.com.cn', 'phone': '8602580860137'}], 'overallOfficials': [{'name': 'Danhua Yao, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinling Hospital, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Resident', 'investigatorFullName': 'Danhua Yao', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}