Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT00587756
Status:
COMPLETED
Last Update Posted:
2008-01-08
First Post:
2008-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alternative to Two-Stage Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-07', 'studyFirstSubmitDate': '2008-01-03', 'studyFirstSubmitQcDate': '2008-01-04', 'lastUpdatePostDateStruct': {'date': '2008-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome was the safety of the procedure. To this purpose we studied morbidity, mortality, amount of blood loss, rate of blood transfusions, and postoperative trend of liver function tests.', 'timeFrame': '30-day and 90-day postoperatively'}], 'secondaryOutcomes': [{'measure': 'The secondary outcome measure was the reliability of the procedure from an oncological standpoint. For this purpose we studied the rate of true local recurrence (cut-edge) after a minimum follow-up of 6 months.', 'timeFrame': 'Minimum Follow-up of 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intraoperative ultrasonography', 'colorectal liver metastases', 'hepatectomy', 'portal vein embolization', 'Liver'], 'conditions': ['Colorectal Cancer', 'Liver Metastases']}, 'referencesModule': {'references': [{'pmid': '11088072', 'type': 'BACKGROUND', 'citation': 'Adam R, Laurent A, Azoulay D, Castaing D, Bismuth H. Two-stage hepatectomy: A planned strategy to treat irresectable liver tumors. Ann Surg. 2000 Dec;232(6):777-85. doi: 10.1097/00000658-200012000-00006.'}, {'pmid': '15570209', 'type': 'BACKGROUND', 'citation': 'Jaeck D, Oussoultzoglou E, Rosso E, Greget M, Weber JC, Bachellier P. A two-stage hepatectomy procedure combined with portal vein embolization to achieve curative resection for initially unresectable multiple and bilobar colorectal liver metastases. Ann Surg. 2004 Dec;240(6):1037-49; discussion 1049-51. doi: 10.1097/01.sla.0000145965.86383.89.'}, {'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': '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': '16269386', 'type': 'BACKGROUND', 'citation': 'Torzilli G, Del Fabbro D, Palmisano A, Donadon M, Bianchi P, Roncalli M, Balzarini L, Montorsi M. Contrast-enhanced intraoperative ultrasonography during hepatectomies for colorectal cancer liver metastases. J Gastrointest Surg. 2005 Nov;9(8):1148-53; discussion 1153-4. doi: 10.1016/j.gassur.2005.08.016.'}]}, 'descriptionModule': {'briefSummary': 'Two-stage hepatectomy with or without portal vein embolization allows to treat multiple bilobar metastases expanding surgical indications for these patients. However, it has some related drawbacks: two operations are needed, and some patients do not complete the treatment strategy for disease progression. Using experience gained from our ultrasound guided resection policy we explored the safety and effectiveness of one-stage surgical procedures in patients otherwise recommended for the two-stage approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients carriers of colorectal cancer liver metastases', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients presenting with resectable colorectal cancer liver metastases (CLM)\n2. 4 or more lesions\n3. Bilobar involvement of the liver\n4. Contact or close adjacency (less than 0.5 cm) of at least one CLM with major intrahepatic vascular structures (1st or 2nd order portal branches and/or hepatic vein at caval confluence).\n\nExclusion Criteria:\n\n1. Patients with 3 or less resectable CLM\n2. Patients with 4 or more resectable CLM but nor bilobar\n3. Patients with 4 or more bilobar resectable CLM without any lesion presenting condition of point 4 of the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT00587756', 'briefTitle': 'Alternative to Two-Stage Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'One-Stage Ultrasound-Guided Hepatectomy for Multiple Bilobar Colorectal Metastases: a Feasible and Effective Alternative to Two-Stage Hepatectomy', 'orgStudyIdInfo': {'id': 'MTX-1STAGE'}, 'secondaryIdInfos': [{'id': 'MTX-CRC-1STAGE'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Prospective cohort of consecutive patients who undergo surgery for colorectal cancer liver metastases', 'interventionNames': ['Procedure: One-stage ultrasound guided hepatectomy']}], 'interventions': [{'name': 'One-stage ultrasound guided hepatectomy', 'type': 'PROCEDURE', 'description': 'Surgical strategy was based on tumor-vessel relationship at intraoperative ultrasonography (IOUS)and on findings at color-Doppler IOUS.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano - Milano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas - Irccs'}], 'overallOfficials': [{'name': 'Guido Torzilli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan, Istituto Clinico Humanitas - IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione Humanitas per la Ricerca', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof. Guido Torzilli', 'oldOrganization': 'University of Milan, Istituto Clinico Humanitas - IRCCS'}}}}