Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-28 @ 5:41 AM
Study NCT ID:
NCT00829335
Status:
COMPLETED
Last Update Posted:
2009-01-27
First Post:
2009-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anatomical Resection of the Liver for Hepatocellular Carcinoma: a New Ultrasound Guided Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-26', 'studyFirstSubmitDate': '2009-01-26', 'studyFirstSubmitQcDate': '2009-01-26', 'lastUpdatePostDateStruct': {'date': '2009-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical feasibility'}], 'secondaryOutcomes': [{'measure': 'Morbidity and mortality', 'timeFrame': '30 and 90 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intraoperative ultrasound', 'Segmentectomy', 'HCC'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '19015467', 'type': 'BACKGROUND', 'citation': 'Torzilli G, Donadon M, Marconi M, Palmisano A, Del Fabbro D, Spinelli A, Botea F, Montorsi M. Hepatectomy for stage B and stage C hepatocellular carcinoma in the Barcelona Clinic Liver Cancer classification: results of a prospective analysis. Arch Surg. 2008 Nov;143(11):1082-90. doi: 10.1001/archsurg.143.11.1082.'}, {'pmid': '17253105', 'type': 'BACKGROUND', 'citation': 'Torzilli G, Palmisano A, Del Fabbro D, Marconi M, Donadon M, Spinelli A, Bianchi PP, Montorsi M. Contrast-enhanced intraoperative ultrasonography during surgery for hepatocellular carcinoma in liver cirrhosis: is it useful or useless? A prospective cohort study of our experience. Ann Surg Oncol. 2007 Apr;14(4):1347-55. doi: 10.1245/s10434-006-9278-3. Epub 2007 Jan 26.'}, {'pmid': '14625736', 'type': 'BACKGROUND', 'citation': 'Torzilli G, Makuuchi M. Ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma. Surg Endosc. 2004 Jan;18(1):136-9. doi: 10.1007/s00464-003-9024-x. Epub 2003 Nov 21.'}, {'pmid': '11768689', 'type': 'BACKGROUND', 'citation': 'Torzilli G, Makuuchi M. Ultrasound-guided liver subsegmentectomy: the peculiarity of segment 4. J Am Coll Surg. 2001 Dec;193(6):706-8. doi: 10.1016/s1072-7515(01)01077-8. No abstract available.'}, {'pmid': '10587196', 'type': 'BACKGROUND', 'citation': 'Torzilli G, Takayama T, Hui AM, Kubota K, Harihara Y, Makuuchi M. A new technical aspect of ultrasound-guided liver surgery. Am J Surg. 1999 Oct;178(4):341-3. doi: 10.1016/s0002-9610(99)00193-2.'}, {'pmid': '16021373', 'type': 'BACKGROUND', 'citation': 'Torzilli G, Montorsi M, Gambetti A, Del Fabbro D, Donadon M, Bianchi P, Olivari N, Makuuchi M. Utility of the hooking technique for cases of major hepatectomy. Surg Endosc. 2005 Aug;19(8):1156-7. doi: 10.1007/s00464-004-2232-1. Epub 2005 May 26.'}, {'pmid': '16953487', 'type': 'BACKGROUND', 'citation': 'Torzilli G, Montorsi M, Del Fabbro D, Palmisano A, Donadon M, Makuuchi M. Ultrasonographically guided surgical approach to liver tumours involving the hepatic veins close to the caval confluence. Br J Surg. 2006 Oct;93(10):1238-46. doi: 10.1002/bjs.5321.'}, {'pmid': '16183489', 'type': 'BACKGROUND', 'citation': 'Torzilli G, Montorsi M, Donadon M, Palmisano A, Del Fabbro D, Gambetti A, Olivari N, Makuuchi M. "Radical but conservative" is the main goal for ultrasonography-guided liver resection: prospective validation of this approach. J Am Coll Surg. 2005 Oct;201(4):517-28. doi: 10.1016/j.jamcollsurg.2005.04.026.'}, {'pmid': '18362622', 'type': 'BACKGROUND', 'citation': 'Torzilli G, Donadon M, Marconi M, Botea F, Palmisano A, Del Fabbro D, Procopio F, Montorsi M. Systematic extended right posterior sectionectomy: a safe and effective alternative to right hepatectomy. Ann Surg. 2008 Apr;247(4):603-11. doi: 10.1097/SLA.0b013e31816387d7.'}, {'pmid': '19838106', 'type': 'DERIVED', 'citation': 'Torzilli G, Procopio F, Cimino M, Del Fabbro D, Palmisano A, Donadon M, Montorsi M. Anatomical segmental and subsegmental resection of the liver for hepatocellular carcinoma: a new approach by means of ultrasound-guided vessel compression. Ann Surg. 2010 Feb;251(2):229-35. doi: 10.1097/SLA.0b013e3181b7fdcd.'}]}, 'descriptionModule': {'briefSummary': 'Anatomical resection is the gold standard approach for liver resection in patients with HCC. A new method for that by means of IOUS-guided finger compression has been devised.', 'detailedDescription': "We herein describe a novel technique for the demarcation of the resection area by means of IOUS-guided finger compression to systematically accomplish anatomical segmental and subsegmental resections.\n\nUsing the IOUS, the tumor and the level targeted for compression are identified. Than, under the IOUS guidance, the surgeon compresses bilaterally the liver at the targeted position resulting in the compression of the portal pedicle feeding the tumor previously identified. This maneuver is constantly monitored in real-time just using the same microconvex probe, and it is maintained until the surface of the targeted liver area begins to discolor, at that time the first assistant marks the discolored area with the electrocautery, and the compression is released. Once the area is demarcated, liver dissection is started under intermittent Pringle's maneuver."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients reffered to our outpatient clinic for evaluation as carriers of HCC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suitable for surgical approach carries of HCC\n* Serum bilirubin level lower than 1.5 mg/dl\n\nExclusion Criteria:\n\n* Presence of ascites\n* Serum bilirubin level equal or higher than 1.6 mg/dl\n* Conditions (size, vascular relation, or infiltration) demanding resection larger than a segmental area\n* Tumor thrombus in portal or hepatic veins'}, 'identificationModule': {'nctId': 'NCT00829335', 'briefTitle': 'Anatomical Resection of the Liver for Hepatocellular Carcinoma: a New Ultrasound Guided Approach', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'Anatomical Segmental and Subsegmental Resection of the Liver for Hepatocellular Carcinoma: a New Approach by Means of Ultrasound-Guided Vessel Compression', 'orgStudyIdInfo': {'id': 'IOUS-COMP GENERAL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCC patients', 'description': 'According with the investigators previously reported selection flow-chart , patients suitable for surgical approach were those with HCC without ascites, without or with esophageal varices for which preoperative endoscopic eradication could be carried out successfully, and with serum bilirubin level lower than 1.5 mg/dl. Potential candidates to systematic segmental or subsegmental resection by IOUS-guided finger compression were considered patients with single HCC located in one or 2 adjacent segments without portal thrombosis, and anyway not demanding for its complete removal a sectional resection or wider.', 'interventionNames': ['Procedure: IOUS-GUIDED INTRAHEPATIC VESSEL COMPRESSION']}], 'interventions': [{'name': 'IOUS-GUIDED INTRAHEPATIC VESSEL COMPRESSION', 'type': 'PROCEDURE', 'description': "Using the IOUS, the tumor and the level targeted for compression are identified. Than, under the IOUS guidance, the surgeon compresses bilaterally the liver at the targeted position resulting in the compression of the portal pedicle feeding the tumor previously identified. This maneuver is constantly monitored in real-time just using the same microconvex probe, and it is maintained until the surface of the targeted liver area begins to discolor, at that time the first assistant marks the discolored area with the electrocautery, and the compression is released. Once the area is demarcated, liver dissection is started under intermittent Pringle's maneuver.", 'armGroupLabels': ['HCC patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'MILANO', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas Irccs', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'overallOfficials': [{'name': 'GUIDO TORZILLI, MD, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Milan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'GUIDO TORZILLI', 'oldOrganization': 'University of Milan - Istituto Clinico Humanitas IRCCS'}}}}