Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT02613156
Status:
COMPLETED
Last Update Posted:
2016-01-05
First Post:
2015-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-02', 'studyFirstSubmitDate': '2015-11-20', 'studyFirstSubmitQcDate': '2015-11-23', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative complications', 'timeFrame': 'within the first 30 days', 'description': 'The operation time, intraoperative blood loss, shortest distance between the tumor edge and normal liver tissue, postoperative pain scores, postoperative time until the patient could walk, postoperative time until the patient could pass gas, hospital stay, and inpatient costs were compared between the two groups.'}], 'secondaryOutcomes': [{'measure': 'relapse-free survival', 'timeFrame': '1 year after surgery', 'description': 'The patients were followed up for one year after surgery, and the relapse-free survival was compared between the two groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laparoscopic', 'hepatocellular carcinoma', 'recurrence'], 'conditions': ['Recurrent Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study is aiming to evaluate the clinical efficacy of complete laparoscopic resection of recurrent hepatocellular carcinoma (HCC).', 'detailedDescription': 'The investigators conducted a prospective study of 64 patients who were diagnosed with recurrent HCC and underwent surgical resection at the Sun Yat-sen University Cancer Center from June 2014 to November 2014; 31 patients were enrolled in the laparoscopic group and underwent complete laparoscopic resection of HCC, and 33 patients were enrolled in the control group and underwent open surgical resection. The operation time, intraoperative blood loss, shortest distance between the tumor edge and normal liver tissue, postoperative pain scores, postoperative time until the patient could walk, postoperative time until the patient could pass gas, hospital stay, and inpatient costs were compared between the two groups. The patients were followed up for one year after surgery, and the relapse-free survival was compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who were diagnosed with recurrent HCC and underwent surgical resection at the Sun Yat-sen University Cancer Center from June 2014 to November 2014', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. recurrent HCC after open surgery\n2. recurrent HCC located in any part of the left lateral lobe or the diaphragm side of the right lobe and near the surface of the liver, which resulted in an easier operation\n3. no significant surgical contraindications\n4. no major vessel or bile duct tumor invasion and metastasis\n5. grade A or B liver function or grade C liver function that recovered to grade A after liver-protective treatment;\n6. the patient and his/her family was willing to undergo laparoscopic resection.\n\nExclusion Criteria:\n\n1. major vessel or bile duct tumor invasion\n2. recurrent HCC located in the right liver parenchyma and near secondary vessels and bile ducts, resulting in a difficult operation\n3. grade C liver function\n4. significant surgical contraindications\n5. the patient and his/her family declined laparoscopic hepatectomy.'}, 'identificationModule': {'nctId': 'NCT02613156', 'briefTitle': 'Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'B20140001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'laparoscopic group', 'description': 'patients in the laparoscopic group underwent laparoscopic resection of recurrent HCC', 'interventionNames': ['Procedure: laparoscopic resection']}, {'label': 'control group', 'description': 'patients in the control group underwent conventional open surgery'}], 'interventions': [{'name': 'laparoscopic resection', 'type': 'PROCEDURE', 'description': 'The surgical instruments used for the laparoscopic group included conventional laparoscopic instruments (three 5 mm trocars, two 10 mm trocars, and two damage-free laparoscopic clamps), the STORZ high-resolution laparoscopic operating system (Germany), the GEN300 ultrasonic scalpel system (Johnson \\& Johnson, USA), a laparoscopic linear cutter stapler (Johnson \\& Johnson, USA), a laparoscopic ultrasound device, LigaSure, bipolar coagulation, titanium laparoscopic clips, and absorbable hemostatic gauze.', 'armGroupLabels': ['laparoscopic group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Li Xu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Zhongguo Zhou', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}