Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-25 @ 4:38 PM
Study NCT ID:
NCT06013657
Status:
COMPLETED
Last Update Posted:
2023-08-28
First Post:
2023-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Resection for Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], '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': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006498', 'term': 'Hepatectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2023-08-15', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'Mortality status of patients'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'Within one week before surgery', 'description': 'Age in years'}, {'measure': 'Sex', 'timeFrame': 'Within one week before surgery', 'description': 'Male or Female'}, {'measure': 'Etiology', 'timeFrame': 'Within one month before surgery', 'description': 'Divided into hepatitis B, hepatitis C, and non-hepatitis in accordance with the laboratory results.'}, {'measure': 'Child-Pugh classification', 'timeFrame': 'Within one month before surgery', 'description': 'Divided into Chilld-Pugh A,B, and C using clinical (presence of encephalopathy or ascites) and laboratory (prothrombin time, albumin, and bilirubin levels) data.'}, {'measure': 'BCLC Classification', 'timeFrame': 'Within one month before surgery', 'description': 'Divided into Stages 0 and A to D using performance status, child-pugh classification, number and size (in cm) of the tumor.'}, {'measure': 'AFP Levels', 'timeFrame': 'Within one month before surgery', 'description': 'Divided into \\<400 and \\>=400'}, {'measure': 'Number of tumors', 'timeFrame': 'Within one month before surgery', 'description': 'Divided into single and multiple tumors according to imaging findings'}, {'measure': 'Largest diameter of tumor', 'timeFrame': 'Within one month before surgery', 'description': 'Measured in cm according to imaging'}, {'measure': 'Surgery method', 'timeFrame': 'During surgery', 'description': 'Laparoscopy or open surgery'}, {'measure': 'Segments resected', 'timeFrame': 'During surgery', 'description': '1-4 segments'}, {'measure': 'Cirrhosis', 'timeFrame': 'Within one month after surgery', 'description': 'Presence of cirrhosis in histopathological findings'}, {'measure': "Edmondson's grading", 'timeFrame': 'Within one month after surgery', 'description': 'Histopathological grading divided into 1 to 4'}, {'measure': 'Tumor differentiation', 'timeFrame': 'Within one month after surgery', 'description': 'Histopathological grading divided well, moderate, moderate to poor, and poor'}, {'measure': 'Length of stay', 'timeFrame': 'An average of two weeks', 'description': 'Measured in days from admission to discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carcinoma,hepatocellular', 'liver neoplasms', 'hepatectomy', 'mortality', 'prognostic'], 'conditions': ['Resectable Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Hepatocellular carcinoma is a type of liver cancer and is one of the leading causes of global cancer death. Surgical resection of the afflicted areas of the liver is one of the treatment methods for this condition. In this retrospective research, the investigators explore the outcomes of liver resection for hepatocellular carcinoma patients undergoing liver resection from 2010 to 2021 in Cipto Mangunkusumo General Hospital, Jakarta. The main outcome is mortality and the secondary outcomes are factors predicting mortality after resection.', 'detailedDescription': "Study design This is a retrospective cohort study.\n\nTreatment of Hepatocellular Carcinoma Patients in RSCM HCC patients are managed by a multidisciplinary team (MDT) consisting of hepatologists, radiologists, pathologists, radiation oncologists, surgeons, and other specialists related to the patient's condition. Confirmed HCC patients are discussed in a weekly MDT team meeting. The meeting assigned patients to treatment options according to the Barcelona Clinic Liver Center (BCLC) staging system, patient preference, and other clinical considerations. Resection is considered for patients at very early (BCLC 0) or early (BCLC A) HCC stages. This includes CP class A patients with a single tumor or less than three small (\\<3 cm) tumors. Patients assigned to surgical resection underwent either laparoscopic or open surgery. One to four segments of the liver were removed. Tissue samples were taken for further pathologic examination.\n\nEthical Clearance The ethics committee of The Faculty of Medicine, University of Indonesia, approved this study by giving an ethical clearance with protocol number 19-11-1313. Informed consent was taken from all patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study used a total population sampling of all patients undergoing liver resection in Cipto Mangunkusumo hospital due to a confirmed diagnosis of hepatocellular carcinoma from 2010 to 2021. Patients undergoing liver resection in other hospitals were excluded, even though diagnosis or further care is done in RSCM. In addition, patients with other malignancies or undergoing other treatment methods were excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing liver resection in Cipto Mangunkusumo hospital due to a confirmed diagnosis of hepatocellular carcinoma from 2010 to 2021\n\nExclusion Criteria:\n\n* Patients undergoing liver resection in other hospitals were excluded, even though diagnosis or further care is done in Cipto Mangunkusumo hospital\n* Patients with other malignancies\n* Patients undergoing other treatment methods for hepatocellular carcinoma.'}, 'identificationModule': {'nctId': 'NCT06013657', 'briefTitle': 'Surgical Resection for Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Dr Cipto Mangunkusumo General Hospital'}, 'officialTitle': "Surgical Resection for Hepatocellular Carcinoma: a Single-Center's One Decade of Experience", 'orgStudyIdInfo': {'id': 'DRCiptoMGH 19-11-1313'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver resection', 'description': 'Patients undergoing liver resection due to hepatocellular carcinoma from 2010 to 2021 in RSCM, Jakarta, an academic tertiary-level national referral hospital in Indonesia.', 'interventionNames': ['Procedure: Liver Resection']}], 'interventions': [{'name': 'Liver Resection', 'type': 'PROCEDURE', 'otherNames': ['Hepatectomy'], 'description': 'Resection of a part of the liver afflicted by hepatocellular carcinoma', 'armGroupLabels': ['Liver resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10440', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Dr. Cipto Mangunkusumo General Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "Raw data without the patients' identification in the form of an Excel sheet will be made available per private request via e-mail correspondence."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ridho Ardhi Syaiful', 'investigatorAffiliation': 'Dr Cipto Mangunkusumo General Hospital'}}}}