Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-21 @ 9:41 PM
Study NCT ID:
NCT04181502
Status:
COMPLETED
Last Update Posted:
2022-10-17
First Post:
2019-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ischemic Preconditioning at a Distance in Liver Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-14', 'studyFirstSubmitDate': '2019-11-20', 'studyFirstSubmitQcDate': '2019-11-27', 'lastUpdatePostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Indocyanine green clearance', 'timeFrame': 'at 5 days after liver resection', 'description': 'Indocyanine green clearance (%/min) by indocyanine green retention, measured with Limon pulse spectrophotometry method.'}], 'secondaryOutcomes': [{'measure': 'Serum transaminases rates', 'timeFrame': 'at day 1,day 3 and day 5 post-hepatectomy.'}, {'measure': 'Prothrombin rate', 'timeFrame': 'at day 5 post-hepatectomy.'}, {'measure': 'the Kidney Disease: Improving Global Outcomes (KDIGO) score', 'timeFrame': 'at day 1,day 3 and day 5 post-hepatectomy.', 'description': 'The score varies from 1 to 4.'}, {'measure': 'the Clavien & Dindo score', 'timeFrame': 'at day 30 post-hepatectomy', 'description': 'this classification in order to rank a post operative complications. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V)'}, {'measure': 'duration of stay in the hospital.', 'timeFrame': 'at day 30 post-hepatectomy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Remote ischemic preconditioning', 'liver resection', 'liver clearance.'], 'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': "During hepatic transection, it exists a high risk of perioperative blood loss. The haemorrhage and its consequences (hypovolemia and blood transfusion) might impact the short and long term morbidity The vascular control by hepatic pedicle clamping (Pringle's maneuver) or total hepatic vascular exclusion, helps minimizing blood loss and leads to a more extensive hepatic resection.\n\nSide effects of vascular control result of ischemia-reperfusion injury (IRI) : these reperfusion lesions results of different mechanisms than those responsible for the ischemic one. IRI cause lesions and postoperative dysfunction of the remaining liver.\n\nAmong strategies to reduce the adverse effects of IRI : ischaemic preconditioning (IPC) has been described. It can be either mechanical (intermittent hepatic pedicle clamping) or pharmacological (sevoflurane inhalation).\n\nShort intermittent vascular occlusions in a organ might produce a resistance to a longer ischaemic period. It is certainly a physiological organ adaptation to tissue hypoxemia, which has a therapeutic potential when targeted.\n\nDuring liver resection, ischaemic preconditioning is realised with periods of hepatic pedicle clamping and unclamping. It decrease morbidity and mortality and prevent postoperative hepatocellular insufficiency due to clamping and IRI at day 5.\n\nIschaemic preconditioning may also be applied remotely. Indeed, it is shown that short ischaemic periods in a target organ can also have a protective effect on distant others. This mechanism involve three signalling pathways : neuronal , humoral and systemic pathways.\n\nIn a previous randomized study, Kanoria and al, demonstrated that the remote ischaemic preconditioning group has shown significant lower rates of serum transaminases and higher liver clearance (spectrophotometry method) than the control group.\n\nA latest study, measuring postoperative prothrombin rates has shown improved liver recovery due to halogen agents such as sevoflurane."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled carcinogenic laparoscopy or laparotomy liver resection\n* Insured under the social security system\n* Inclined to comply to the study protocol and its duration.\n\nExclusion Criteria:\n\n* Patient under guardianship\n* Pregnancy or breastfeeding\n* Severe lower limb vascular disease\n* Emergency surgery\n* Contraindication of a treatment from the protocol\n* Psychological disorder with difficulty to accede the protocol\n* Absence of written informed consent\n* Refusal to sign the protocol\n* Non-registration to the social security system'}, 'identificationModule': {'nctId': 'NCT04181502', 'acronym': 'HEPATOPROTECT', 'briefTitle': 'Ischemic Preconditioning at a Distance in Liver Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Randomized, Single-blind Study of Remote Ischemic Preconditioning in Hepatectomies', 'orgStudyIdInfo': {'id': '2017_66'}, 'secondaryIdInfos': [{'id': '2018-A03038-47', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inflation of a pneumatic tourniquet', 'interventionNames': ['Procedure: pneumatic tourniquet']}, {'type': 'SHAM_COMPARATOR', 'label': 'No inflation', 'description': 'No inflation of the pneumatic tourniquet placed on the lower limb', 'interventionNames': ['Other: No inflation']}], 'interventions': [{'name': 'pneumatic tourniquet', 'type': 'PROCEDURE', 'description': 'a pneumatic tourniquet around 200 mmHg after venous chase of the lower limb, during 5 minutes then deflated. Repeated twice after general anaesthesia and prior to incision.', 'armGroupLabels': ['Inflation of a pneumatic tourniquet']}, {'name': 'No inflation', 'type': 'OTHER', 'description': 'No inflation of the pneumatic tourniquet placed on the lower limb', 'armGroupLabels': ['No inflation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hop Claude Huriez Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Gilles Lebuffe, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}