Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT02728167
Status:
TERMINATED
Last Update Posted:
2018-08-15
First Post:
2016-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of HIFU-AR on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'whyStopped': 'Poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2016-03-22', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normalized blood loss (ml/cm2)', 'timeFrame': 'During hepatectomy', 'description': 'To compare the blood loss during hepactectomy in patients treated by HIFU-AR versus standard liver resection'}], 'secondaryOutcomes': [{'measure': 'Total blood los (ml)', 'timeFrame': 'During hepatectomy'}, {'measure': 'Transection time', 'timeFrame': 'During hepatectomy'}, {'measure': 'Transection time/cm2 of liver area (min/cm2)', 'timeFrame': 'During hepatectomy'}, {'measure': 'Hemostasis time', 'timeFrame': 'During hepatectomy'}, {'measure': 'Clip density on the liver section area', 'timeFrame': 'During hepatectomy', 'description': 'Number of clips/cm2'}, {'measure': 'Rate of Pringle manoeuvre', 'timeFrame': 'During hepatectomy'}, {'measure': 'Rate of patients needing a blood transfusion', 'timeFrame': 'During hepatectomy'}, {'measure': 'Length of hospital stay', 'timeFrame': '10 days'}, {'measure': 'Number of patients with postoperative complications assessed using Dindo-Clavien classification', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatectomy', 'Liver metastasis', 'High-Intensity Focused Ultrasound', 'Liver metastases (LM) requiring surgery'], 'conditions': ['Liver Metastasis']}, 'referencesModule': {'references': [{'pmid': '28166812', 'type': 'DERIVED', 'citation': 'Dupre A, Perol D, Blanc E, Peyrat P, Basso V, Chen Y, Vincenot J, Kocot A, Melodelima D, Rivoire M. Efficacy of high-intensity focused ultrasound-assisted hepatic resection (HIFU-AR) on blood loss reduction in patients with liver metastases requiring hepatectomy: study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):57. doi: 10.1186/s13063-017-1801-2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss compared to standard liver resection in patients with LM.This is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years at the day of consenting to the study.\n* Patients with liver metastases requiring a hepatectomy for ≥ 2 segments.\n* ECOG PS ≤ 1.\n* Adequate bone marrow and liver function at baseline as defined below:\n\n * Platelet count ≥ 100 x 109/l, and hemoglobin of ≥ 9 g/dl),\n * Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN.\n* Recovered from prior anti-neoplasic treatment-related toxicity (grade \\<2 persistent treatment-related toxicity as per CTCAE v4 are accepted).\n* Willingness for follow-up visits.\n* Covered by a medical insurance.\n* Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.\n\nExclusion Criteria:\n\n* Patients having previously undergone\n\n * a major hepatic surgery (i.e. more than 3 liver segments) or\n * biliary major surgery.\n* Patient with cirrhosis or sinusoidal obstruction syndrome with portal hypertension.\n* Pregnant women (women of childbearing potential are required to have a negative pregnancy test within 72 hours prior to inclusion). A positive urine test must be confirmed by a serum pregnancy test.'}, 'identificationModule': {'nctId': 'NCT02728167', 'acronym': 'HIFU-AR', 'briefTitle': 'Efficacy of HIFU-AR on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'Randomized, Open-label, Phase II Study to Evaluate the Efficacy of High-Intensity Focused Ultrasound Assisted Hepatic Resection (HIFU-AR) on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy', 'orgStudyIdInfo': {'id': 'HIFU-AR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-coagulation by HIFU-AR', 'description': 'Pre-coagulation of the liver parenchyma with HIFU and standard liver resection', 'interventionNames': ['Device: Pre-coagulation of the liver parenchyma with HIFU']}, {'type': 'NO_INTERVENTION', 'label': 'Standard liver resection', 'description': 'Standard liver resection'}], 'interventions': [{'name': 'Pre-coagulation of the liver parenchyma with HIFU', 'type': 'DEVICE', 'description': '6 to 10 (or more if necessary) side-to-side 40-seconde HIFU treatments', 'armGroupLabels': ['Pre-coagulation by HIFU-AR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Michel RIVOIRE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Leon Bérard'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}