Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT00797251
Status:
UNKNOWN
Last Update Posted:
2008-11-25
First Post:
2008-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anatomical Right Posterior Sectionectomy of the Liver by IOUS-Guided Finger Compression
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': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2009-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-11-24', 'studyFirstSubmitDate': '2008-11-24', 'studyFirstSubmitQcDate': '2008-11-24', 'lastUpdatePostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is the safety of the anatomical right posterior sectionectomy performed IOUS-guided finger compression.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'The secondary outcome is the efficacy of the anatomical right posterior sectionectomy performed by IOUS-guided finger compression.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colorectal liver metastasis', 'hepatocellular carcinoma', 'liver surgery', 'intraoperative ultrasound', 'finger-compression'], 'conditions': ['Colorectal Liver Metastases', 'Hepatocellular Carcinoma', 'Liver Malignancies']}, 'referencesModule': {'references': [{'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': '17893508', 'type': 'BACKGROUND', 'citation': 'Torzilli G, Donadon M, Montorsi M. The surgical margin in liver resection for hepatocellular carcinoma: a real problem or not? Ann Surg. 2007 Oct;246(4):690-1; author reply 691-2. doi: 10.1097/SLA.0b013e318156e286. No abstract available.'}, {'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': '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': '2166006', 'type': 'BACKGROUND', 'citation': 'Takasaki K, Kobayashi S, Tanaka S, Saito A, Yamamoto M, Hanyu F. Highly anatomically systematized hepatic resection with Glissonean sheath code transection at the hepatic hilus. Int Surg. 1990 Apr-Jun;75(2):73-7.'}, {'pmid': '1734576', 'type': 'BACKGROUND', 'citation': 'Launois B, Jamieson GG. The posterior intrahepatic approach for hepatectomy or removal of segments of the liver. Surg Gynecol Obstet. 1992 Feb;174(2):155-8.'}, {'pmid': '2996162', 'type': 'BACKGROUND', 'citation': 'Makuuchi M, Hasegawa H, Yamazaki S. Ultrasonically guided subsegmentectomy. Surg Gynecol Obstet. 1985 Oct;161(4):346-50.'}]}, 'descriptionModule': {'briefSummary': 'The use of intraoperative ultrasound (IOUS) allows us to perform new conservative hepatectomies. The investigators previously reported the systematic subsegmentectomy by IOUS-guided finger compression for segments 2-3, which is currently applied for patients with hepatocellular carcinoma (HCC)on cirrhosis. The investigators herein describe a novel technique, which consists in the systematic right posterior sectionectomy by IOUS-guided finger compression.', 'detailedDescription': 'A novel technique for the demarcation of the resection area by means of IOUS-guided finger compression to accomplish a right posterior sectionectomy is described. Dissection or encirclement of the sectional pedicles for resection area demarcation is thus avoided. Ten patients underwent this technique successfully without mortality or major morbidity. IOUS-guided finger compression of sectional portal pedicle feeding the right posterior section is a feasible, safe, and effective method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population include patients with primary or secondary liver tumors in the right posterior section of the liver eligible to a right posterior sectionectomy as a primary surgical procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with tumors at least at 1 cm distally to the bifurcation of the right portal vein (bifurcation of P5-8 and P6-7) eligible for right posterior sectionectomy, namely the anatomical removal of segment 6 and 7, were considered potential candidates to this procedure. Precisely, these criteria were adopted:\n\n * Patients with hepatocellular carcinoma (HCC) with infiltrative growing pattern in contact with P6-7;\n * Patients with any type of HCC in contact with P6-7 with distal bile duct dilation;\n * Patients with colorectal liver metastasis (CLM) in contact with P6-7.\n\nExclusion Criteria:\n\n* Exclusion criteria for carrying out the herein described procedure was considered the presence of tumoral thrombosis in P6-7.'}, 'identificationModule': {'nctId': 'NCT00797251', 'briefTitle': 'Anatomical Right Posterior Sectionectomy of the Liver by IOUS-Guided Finger Compression', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'A Novel Simple Technique for Performing Anatomical Right Posterior Sectionectomy of the Liver: the Ultrasound-Guided Finger Compression', 'orgStudyIdInfo': {'id': 'IOUS-Compression'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Right posterior section group', 'description': 'Patients with tumors in the right posterior section of the liver (segments 6-7)', 'interventionNames': ['Procedure: Anatomical right posterior sectionectomy of the liver by IOUS-guided finger compression.']}], 'interventions': [{'name': 'Anatomical right posterior sectionectomy of the liver by IOUS-guided finger compression.', 'type': 'PROCEDURE', 'otherNames': ['anatomic resection of segment 6-7'], 'description': 'The technique consists in IOUS-guided finger compression of the right posterior portal pedicle at the level closest to the tumor but oncologically suitable. This method allows us to anatomically mark the area of resection with nor hilar plate nor IOUS-guided puncture of vessels, which are up to date the only two techniques available to perform anatomical right posterior sectionectomy - namely the removal of segment 6 and 7.', 'armGroupLabels': ['Right posterior section group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milan', 'country': 'Italy', 'facility': 'University of Milan School of Medicine, IRCCS Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'overallOfficials': [{'name': 'Guido Torzilli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan School of Medicine, IRCCS Istituto Clinico Humanitas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Guido Torzilli, MD, PhD', 'oldOrganization': 'University of Milan School of Medicine'}}}}