Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-29 @ 9:01 AM
Study NCT ID:
NCT01819961
Status:
UNKNOWN
Last Update Posted:
2013-03-28
First Post:
2013-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'C568345', 'term': 'fish oil triglycerides'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-27', 'studyFirstSubmitDate': '2013-03-20', 'studyFirstSubmitQcDate': '2013-03-27', 'lastUpdatePostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'infective complications', 'timeFrame': 'within the first 30 days after surgery'}], 'secondaryOutcomes': [{'measure': 'length of hospital stay', 'timeFrame': 'average of 2 weeks'}, {'measure': 'plasma immunological markers', 'timeFrame': 'from 1 day before surgery to 7 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastric Tumor', 'Pancreatic Tumor', 'Liver Tumor']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of postoperative parenteral fish oil on clinical outcome and immune function after major laparoscopic abdominal surgery.', 'detailedDescription': 'Postoperative patients are randomized by a sealed envelope to receive either a 50:50 (vol/vol) mixture of an oil rich in medium-chain fatty acids and soybean oil (termed MCT/LCT) or a mixture of MCT/LCT and fish oil Omegaven for 7 days. Full blood count, biochemistry and coagulation are routinely assessed. Fresh blood samples are centrifuged into plasma, red blood cells and lymphocytes then stored at -80°C pending analysis.\n\nThe primary endpoint was numbers of infective complications.Secondary endpoints were other clinical outcomes, length of hospital stay, and in-hospital mortality, along with plasma immunological markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing an elective major laparoscopic abdominal surgery and required at least 5 days of parenteral nutrition\n\nExclusion Criteria:\n\n* Metabolic disease\n* Chronic kidney or liver failure\n* Shock\n* Contraindications for lipid administration\n* PN during the 15 days before hospitalisation'}, 'identificationModule': {'nctId': 'NCT01819961', 'briefTitle': 'Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': 'Randomized Clinical Trial of Omega-3 Fatty Acid-supplemented Parenteral Nutrition Versus Standard Parenteral Nutrition in Patients Undergoing Major Laparoscopic Abdominal Surgery', 'orgStudyIdInfo': {'id': 'Fo-Lap'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCT/LCT', 'description': 'Structural Fat Emulsion Injection 250ml per day, for 7 days', 'interventionNames': ['Drug: MCT/LCT']}, {'type': 'EXPERIMENTAL', 'label': 'MCT/LCT and fish oil', 'description': 'Structural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days.', 'interventionNames': ['Drug: MCT/LCT and fish oil']}], 'interventions': [{'name': 'MCT/LCT and fish oil', 'type': 'DRUG', 'otherNames': ['Structural Fat Emulsion Injection (Fresenius-Kabi, Germany) and fish oil (Omegaven,Fresenius-Kabi, Germany)'], 'armGroupLabels': ['MCT/LCT and fish oil']}, {'name': 'MCT/LCT', 'type': 'DRUG', 'otherNames': ['Structural Fat Emulsion Injection (Fresenius-Kabi, Germany)'], 'armGroupLabels': ['MCT/LCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310016', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Wei Zhou', 'role': 'CONTACT', 'email': 'nuzwlvran@yahoo.com.cn', 'phone': '+86-13588706479'}], 'facility': 'Sir Run Run Shaw Hosptial', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Wei Zhou, MD, PhD', 'role': 'CONTACT', 'email': 'nuzwlvran@yahoo.com.cn', 'phone': '+86-13588706479'}], 'overallOfficials': [{'name': 'Yiping Mou, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sir Run Run Shaw Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wei Zhou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending', 'investigatorFullName': 'Wei Zhou', 'investigatorAffiliation': 'Sir Run Run Shaw Hospital'}}}}