Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT02031094
Status:
COMPLETED
Last Update Posted:
2014-10-16
First Post:
2013-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Expenditure and Regeneration Following Liver Resection Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-15', 'studyFirstSubmitDate': '2013-11-21', 'studyFirstSubmitQcDate': '2014-01-07', 'lastUpdatePostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Volume of liver resected (g)', 'timeFrame': 'Post operative day 1'}, {'measure': 'Resting energy expenditure (REE) (Kcal)', 'timeFrame': '4 weeks post-operative'}, {'measure': 'Post-operative blood tests (FBC, U&E, LFT, Coag)', 'timeFrame': 'Post-operative days 1-7'}, {'measure': 'Complications', 'timeFrame': 'Day of surgery and post-operative days 1-30'}], 'primaryOutcomes': [{'measure': 'Change in Resting Energy Expenditure (Kcal) following liver resection', 'timeFrame': '2 weeks pre-operatively and post-operative days 3,5 and 7'}], 'secondaryOutcomes': [{'measure': 'Change in total energy expenditure (Kcal) following liver resection', 'timeFrame': '2 weeks pre-operatively and post-operative days 3,5 and 7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Liver Resection']}, 'descriptionModule': {'briefSummary': 'This observational study will measure resting energy expenditure in patients who have undergone liver resection and compare methods of measuring resting energy expenditure.', 'detailedDescription': 'Penetrating liver injury occurs commonly in victims of battlefield trauma. It is associated with a high mortality and morbidity rate. Management of liver injury is complex and challenging and can often involve debridement or anatomical resection of liver tissue.\n\nFollowing liver resection, the liver regenerates to its original volume. Liver regeneration involves complex metabolic processes and maximal regeneration occurs over the first post operative week. This process is highly energy dependent and adds a further burden on post operative energy and therefore nutritional requirements.\n\nInadequate post-operative nutrition is associated with poorer outcomes and complication rates. Additionally, over feeding is also associated with adverse outcome. The actual additional energy expenditure involved in liver regeneration is not currently known and therefore accurate calorific balance remains a challenge.\n\nThe measurement of energy expenditure in these patients is therefore important. Traditionally energy expenditure has been measured by indirect calorimetry and doubly labelled water. These techniques require skilled operators and are often impractical for everyday clinical usage and impossible in the deployed setting.\n\nA recent development is a lightweight armband that measures total and resting energy expenditure. It has been validated against the gold standard techniques in various settings including cancer cachexia, obesity and healthy volunteers and is deemed highly acceptable also. It has not been validated in the unique setting of liver regeneration.\n\nTherefore this study will assess the energy expenditure in patients undergoing liver regeneration and attempt to validate a new minimally invasive device against the traditional measurements of energy expenditure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing hepatic resection for benign or malignant neoplasms.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Patients undergoing liver resection for benign or malignant hepatic neoplasm\n\nExclusion Criteria:\n\n* Inability to give written, informed consent.\n* Jaundice (Bilirubin \\> 100 μmol/L)\n* Liver resection combined with secondary surgical procedure.\n* Age \\< 18 years\n* Pregnant women\n* Unable to tolerate either measuring device'}, 'identificationModule': {'nctId': 'NCT02031094', 'acronym': 'EAGLE', 'briefTitle': 'Energy Expenditure and Regeneration Following Liver Resection Resection', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'The Effect of Liver Regeneration on Resting Energy Expenditure After Liver Resectional Surgery', 'orgStudyIdInfo': {'id': '13/SS/0019'}, 'secondaryIdInfos': [{'id': '2013/R/END/01', 'type': 'OTHER', 'domain': 'NHS Lothian'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Major resection', 'description': 'Patients undergoing resection of \\>3 segments (resting energy expenditure measured by Sense Wear Armband and indirect calorimetry)', 'interventionNames': ['Other: Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure']}, {'label': 'Minor resection', 'description': 'Patients undergoing resection of \\</= 3 segments (resting energy expenditure measured by Sense Wear Armband and indirect calorimetry)', 'interventionNames': ['Other: Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure']}], 'interventions': [{'name': 'Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure', 'type': 'OTHER', 'description': 'Observational methods of measuring resting energy expenditure', 'armGroupLabels': ['Major resection', 'Minor resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SA', 'city': 'Edinburgh', 'state': 'Lothian', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Michael j Hughes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh'}, {'name': 'Stephen J Wigmore', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Edinburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal College of Surgeons of Edinburgh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}