Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT01683357
Status:
COMPLETED
Last Update Posted:
2012-09-11
First Post:
2012-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-06', 'studyFirstSubmitDate': '2012-09-04', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'reliability of the procedure from an oncological standpoint', 'timeFrame': '6-months of minimum follow-up for local recurrences; 5 years actuarial curves for overall survival and time to recurrence', 'description': '1. the rate of true local recurrence (cut-edge) after a minimum follow-up of 6 months;\n2. the long-term follow-up, analysing the overall survival (survival after surgery), time to recurrence (survival without recurrence), and time to liver recurrence (survival without liver recurrence).\n3. the overall survival compared with that based on an intention-to-treat criterion also including the outcome of those patients who met the inclusion criteria but resulted unresectable on exploration.'}], 'primaryOutcomes': [{'measure': 'feasibility on an intention-to-treat basis', 'timeFrame': 'at the time of surgical intervention'}], 'secondaryOutcomes': [{'measure': 'safety of the procedure', 'timeFrame': 'At 30 and 90 postoperative days', 'description': 'Peroperative morbidity and mortality as classified according with Dindo-Clavien classification (see ref.); Amount of intraoperative blood loss and blood transfusions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Liver Metastases', 'Surgery', 'Intraoperative Ultrasound'], 'conditions': ['Liver Metastases']}, 'referencesModule': {'references': [{'pmid': '19092344', 'type': 'BACKGROUND', 'citation': 'Wicherts DA, Miller R, de Haas RJ, Bitsakou G, Vibert E, Veilhan LA, Azoulay D, Bismuth H, Castaing D, Adam R. Long-term results of two-stage hepatectomy for irresectable colorectal cancer liver metastases. Ann Surg. 2008 Dec;248(6):994-1005. doi: 10.1097/SLA.0b013e3181907fd9.'}, {'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': '21710481', 'type': 'BACKGROUND', 'citation': 'Narita M, Oussoultzoglou E, Jaeck D, Fuchschuber P, Rosso E, Pessaux P, Marzano E, Bachellier P. Two-stage hepatectomy for multiple bilobar colorectal liver metastases. Br J Surg. 2011 Oct;98(10):1463-75. doi: 10.1002/bjs.7580. Epub 2011 Jun 28.'}, {'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': '10749608', 'type': 'BACKGROUND', 'citation': 'Minagawa M, Makuuchi M, Torzilli G, Takayama T, Kawasaki S, Kosuge T, Yamamoto J, Imamura H. Extension of the frontiers of surgical indications in the treatment of liver metastases from colorectal cancer: long-term results. Ann Surg. 2000 Apr;231(4):487-99. doi: 10.1097/00000658-200004000-00006.'}, {'pmid': '15273542', 'type': 'BACKGROUND', 'citation': 'Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.'}, {'pmid': '19541011', 'type': 'RESULT', 'citation': 'Torzilli G, Procopio F, Botea F, Marconi M, Del Fabbro D, Donadon M, Palmisano A, Spinelli A, Montorsi M. One-stage ultrasonographically guided hepatectomy for multiple bilobar colorectal metastases: a feasible and effective alternative to the 2-stage approach. Surgery. 2009 Jul;146(1):60-71. doi: 10.1016/j.surg.2009.02.017.'}, {'pmid': '16183489', 'type': 'RESULT', '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': '20799289', 'type': 'RESULT', 'citation': 'Torzilli G, Garancini M, Donadon M, Cimino M, Procopio F, Montorsi M. Intraoperative ultrasonographic detection of communicating veins between adjacent hepatic veins during hepatectomy for tumours at the hepatocaval confluence. Br J Surg. 2010 Dec;97(12):1867-73. doi: 10.1002/bjs.7230. Epub 2010 Aug 26.'}, {'pmid': '16953487', 'type': 'RESULT', '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': '19858707', 'type': 'RESULT', 'citation': 'Torzilli G, Palmisano A, Procopio F, Cimino M, Botea F, Donadon M, Del Fabbro D, Montorsi M. A new systematic small for size resection for liver tumors invading the middle hepatic vein at its caval confluence: mini-mesohepatectomy. Ann Surg. 2010 Jan;251(1):33-9. doi: 10.1097/SLA.0b013e3181b61db9.'}, {'pmid': '21975322', 'type': 'RESULT', 'citation': 'Torzilli G, Procopio F, Donadon M, Del Fabbro D, Cimino M, Montorsi M. Safety of intermittent Pringle maneuver cumulative time exceeding 120 minutes in liver resection: a further step in favor of the "radical but conservative" policy. Ann Surg. 2012 Feb;255(2):270-80. doi: 10.1097/SLA.0b013e318232b375.'}, {'pmid': '18362622', 'type': 'RESULT', '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': '16269386', 'type': 'RESULT', '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': 'It is not rare that two-stage hepatectomy for multiple bilobar colorectal liver metastases (CLM) be left incomplete because of disease progression or technical reasons. One-stage hepatectomy seems a feasible and safe alternative, however, long-term results are lacking. This study aims to provide evidence that one-stage hepatectomy compelling tumor exposure provides adequate long-term results with low risk of local recurrences.', 'detailedDescription': 'Eligibility Criteria The prospectively recruited cohort of patients herein analysed is the result of a policy for which those patients considered resectable and presenting 4 or more lesions, bilobar CLM were systematically approached in a one stage operation.\n\nPatients were considered unresectable once there was concomitance of more than 3 lung metastases, diffuse peritoneal carcinomatosis, and/or extra-hilar lymph node metastasis.\n\nOutcome measures The primary outcome was the feasibility on an intention-to-treat basis. To this purpose we studied the ratio between the number of patients surgically explored and those who effectively received resection.\n\nThe secondary 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.\n\nThe tertiary outcome measure was the reliability of the procedure from an oncological standpoint. For this purpose we studied the following:\n\n1. the rate of true local recurrence (cut-edge) after a minimum follow-up of 6 months;\n2. the long-term follow-up, analysing the overall survival (survival after surgery), time to recurrence (survival without recurrence), and time to liver recurrence (survival without liver recurrence).\n3. the overall survival compared with that based on an intention-to-treat criterion also including the outcome of those patients who met the inclusion criteria but resulted unresectable on exploration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with multiple (\\> or = to 4) and bilobar colorectal liver metastases', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThose patients considered resectable and presenting 4 or more CLM, involving both liver lobes are systematically approached in a one stage operation.\n\nExclusion Criteria:\n\nPatients carriers of more than 3 lung metastases, and/or diffuse peritoneal carcinomatosis, and/or extra-hilar lymph node metastasis'}, 'identificationModule': {'nctId': 'NCT01683357', 'briefTitle': 'Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases', 'organization': {'class': 'OTHER', 'fullName': 'University of Milan'}, 'officialTitle': 'LONG-TERM RESULTS AFTER ONE-STAGE ULTRASOUND-GUIDED HEPATECTOMY IN PATIENTS WITH MULTIPLE BILOBAR COLORECTAL LIVER METASTASES: TOWARDS NEW CONCEPTS OF RADICAL RESECTION BY MEANS OF AN INTENTION TO TREAT ANALYSES', 'orgStudyIdInfo': {'id': 'MTX-1STAGE LONG-TERM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple Bilobar CLM', 'description': 'Patients selected for hepatectomy because carrier of multiple (\\> or = to 4), bilobar CLM', 'interventionNames': ['Procedure: Hepatectomy']}], 'interventions': [{'name': 'Hepatectomy', 'type': 'PROCEDURE', 'description': 'Intraoperative ultrasound (IOUS) criteria for tumor-vessel relations let maximizing the preservation of the hepatic vascular skeleton. Contact between colorectal liver metastases and a major intrahepatic vessel is not by itself a criteria for vessel resection: tumor exposure is not contraindicated.\n\nIf resection of a hepatic vein (HV), resection of the liver parenchyma drained by that vein is considered or not based on color-flow IOUS findings (hepatofugal blood flow in the feeding portal branch, evidence or not of communicating veins between adjacent HVs, evidence or not of accessory HVs).\n\nParenchymal transection is performed under intermittent clamping by the Pringle maneuver. Drains are always inserted and a chest tube is inserted in patients undergoing thoracophrenolaparotomy.', 'armGroupLabels': ['Multiple Bilobar CLM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'facility': 'Humanitas Cancer Center', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'overallOfficials': [{'name': 'Guido Torzilli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan, Humanitas Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Liver Surgery Unit, Humanitas Cancer Center - Associate Professor, University of Milan', 'investigatorFullName': 'Prof. Guido Torzilli', 'investigatorAffiliation': 'University of Milan'}}}}