Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
Study NCT ID:
NCT06390228
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2024-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Hepatectomy on HCC Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2024-04-26', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence-free survival', 'timeFrame': '2019.1-2023.8', 'description': 'the time from the time of radical surgery to the time of HCC recurrence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'recurrence', 'hepatectomy'], 'conditions': ['Hepatocellular Carcinoma Stage I', 'Recurrence']}, 'descriptionModule': {'briefSummary': 'Hepatectomy is the first option for the treatment of hepatocellular carcinoma(HCC) at CNLC Ib stage. HCC patients who undergo curative hepatectomy may experience varying remnant liver volumes and thus leads to different oncological outcomes.', 'detailedDescription': 'Patients with hepatocellular carcinoma (HCC) who undergo curative hepatectomy may experience varying remnant liver volumes. The investigators aimed to evaluate whether the extent of liver resection has an effect on postoperative recurrence in HCC patients. A retrospective analysis was conducted on 197 patients who underwent hepatectomy for a solitary HCC lesion measuring ≥5 cm between January 2019 and June 2022. Patients were divided into major hepatectomy (MAH) group (n=70) and minor hepatectomy (MIH) group (n=127) based on the extent of liver resection. Recurrence-free survival (RFS) was compared between the two groups. Propensity score matching was employed to mitigate potential biases in this research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'a final sample of 197 patients was included in this study. Among these patients, 70 underwent MAH (including 62 right hepatectomies, 4 extended right hepatectomies, and 4 extended left hepatectomies), while 127 patients underwent MIH (including 32 left hepatectomies, 10 right anterior hepatectomies, 17 right posterior hepatectomies, 11 mesohepatectomies, 20 left lateral hepatectomies, 21 right partial hepatectomies, 3 left partial hepatectomies, and 13 single segment hepatectomies). Using PSM analysis, 49 pairs of matched patients were identified from each group to compare outcomes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed solitary HCC with a size of ≥5 cm\n* Eastern Cooperative Oncology Group score of 0 or 1\n* preoperative indocyanine green retention rate at 15 minutes ≤15% and Child-Pugh A classification\n* no evidence of vascular invasion or extrahepatic disease.\n\nExclusion Criteria:\n\n* not diagnosed with HCC or had an HCC measuring \\<5 cm\n* had confirmed tumor metastases or macrovascular invasion based on radiological examinations\n* died within 90 days after surgery were excluded'}, 'identificationModule': {'nctId': 'NCT06390228', 'acronym': 'HCC', 'briefTitle': 'Impact of Hepatectomy on HCC Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'Anhui Medical University'}, 'officialTitle': 'Impact of Major Hepatectomy on Recurrence After Resection of Hepatocellular Carcinoma at China Liver Cancer Staging (CNLC) Stage : a Propensity Score Matching Study', 'orgStudyIdInfo': {'id': '2023-RE-285'}, 'secondaryIdInfos': [{'id': 'No. 82172071', 'type': 'OTHER_GRANT', 'domain': 'the National Natural Science Foundation of China'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Major hepatectomy', 'description': "Major hepatectomy was defined as the removal of four or more Couinaud's liver segments.", 'interventionNames': ['Procedure: Major hepatectomy']}, {'label': 'Minor hepatectomy', 'description': "Minor hepatectomy was defined as the removal of three or fewer Couinaud's segments."}], 'interventions': [{'name': 'Major hepatectomy', 'type': 'PROCEDURE', 'otherNames': ['minor hepatectomy'], 'description': 'the extent of liver resection', 'armGroupLabels': ['Major hepatectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'overallOfficials': [{'name': 'Dalong Yin, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital of University of Science and Technology of China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anhui Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Kunyuan Jiang', 'investigatorAffiliation': 'Anhui Medical University'}}}}