Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-02 @ 7:02 AM
Study NCT ID:
NCT01669356
Status:
COMPLETED
Last Update Posted:
2014-04-01
First Post:
2012-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-30', 'studyFirstSubmitDate': '2012-08-11', 'studyFirstSubmitQcDate': '2012-08-16', 'lastUpdatePostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'complicatons incidence after surgery', 'timeFrame': '28 days after surgery', 'description': 'complications involve anastomotic leakage, incision infection, pneumonia, catherter-related blood stream infection, respiratory failure'}], 'primaryOutcomes': [{'measure': 'postoperative laboratory parameters changes for nutrition assessment compared to preoperation', 'timeFrame': 'from one day before surgery to the 7th postoperative day', 'description': 'plasma albumin, prealbumin, transferrin, retinaldehyde-binding protein, total lymphocytes counts'}, {'measure': 'postoperative body composition change compared to preoperation measurement', 'timeFrame': 'from one day before surgery to the 7th postoperative day', 'description': 'postoperative body composition is compared to preoperation, bioelectrical impedance spectroscopy is used for measurement of body composition'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['malnutrition', 'parenteral supplement', 'rest metabolic rate', 'postoperative complications'], 'conditions': ['Esophagus Cancer']}, 'referencesModule': {'references': [{'pmid': '27208039', 'type': 'DERIVED', 'citation': 'Wu W, Zhong M, Zhu DM, Song JQ, Huang JF, Wang Q, Tan LJ. Effect of Early Full-Calorie Nutrition Support Following Esophagectomy: A Randomized Controlled Trial. JPEN J Parenter Enteral Nutr. 2017 Sep;41(7):1146-1154. doi: 10.1177/0148607116651509. Epub 2016 May 20.'}]}, 'descriptionModule': {'briefSummary': 'Malnutrition is common in esophagus cancer patients, especially after surgery therapy. Whether parenteral supplement with enteral nutrtion is benificial for patients after esophagectomy is controversial, when compared with enteral nutrition alone. In this study, the investigators are to examine the effect of enteral nutrition supplemented with parenteral nutrtion on nutrition status after esophagectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of esophagus cancer\n* Undergo esophagectomy\n* Nasoenteral tube is placed or surgical jejunostomy is performed\n\nExclusion Criteria:\n\n* Contraindication for enteral nutrition or parenteral nutrition\n* Malnutrition before surgery ( BMI \\> 30 or \\< 18.5)\n* Hepatic dysfunction preoperatively\n* Renal dysfunction preoperatively\n* Infection before surgery\n* Usage of corticosteroid before surgery'}, 'identificationModule': {'nctId': 'NCT01669356', 'briefTitle': 'The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'The Effect of Parenteral Nutrition Supplement Versus Enteral Nutrition Alone on Nutrition Status After Esophagectomy: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PNsupplESO'}, 'secondaryIdInfos': [{'id': 'Energy Supply Trial', 'type': 'OTHER', 'domain': 'Shanghai Zhongshan Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PN supplement', 'description': 'Parenteral supplement with enteral nutrition for patients after esophagectomy', 'interventionNames': ['Other: Parenteral supplement with enteral nutrition for patients after esophagectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EN alone', 'description': 'Enteral nutrition alone for patients after esophagectomy', 'interventionNames': ['Other: Enteral Nutrition alone for patients after esophagectomy']}], 'interventions': [{'name': 'Parenteral supplement with enteral nutrition for patients after esophagectomy', 'type': 'OTHER', 'armGroupLabels': ['PN supplement']}, {'name': 'Enteral Nutrition alone for patients after esophagectomy', 'type': 'OTHER', 'armGroupLabels': ['EN alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}