Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases
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| First Received Date ICMJE | September 4, 2012 | ||||
| Last Updated Date | September 6, 2012 | ||||
| Start Date ICMJE | September 2001 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
feasibility on an intention-to-treat basis [ Time Frame: at the time of surgical intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01683357 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
safety of the procedure [ Time Frame: At 30 and 90 postoperative days ] [ Designated as safety issue: Yes ] Peroperative morbidity and mortality as classified according with Dindo-Clavien classification (see ref.); Amount of intraoperative blood loss and blood transfusions. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE |
reliability of the procedure from an oncological standpoint [ Time Frame: 6-months of minimum follow-up for local recurrences; 5 years actuarial curves for overall survival and time to recurrence ] [ Designated as safety issue: No ]
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| Original Other Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. Patients were considered unresectable once there was concomitance of more than 3 lung metastases, diffuse peritoneal carcinomatosis, and/or extra-hilar lymph node metastasis. Outcome 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. The 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. The tertiary outcome measure was the reliability of the procedure from an oncological standpoint. For this purpose we studied the following:
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients with multiple (> or = to 4) and bilobar colorectal liver metastases |
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| Condition ICMJE | Liver Metastases | ||||
| Intervention ICMJE | Procedure: Hepatectomy
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. If 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). Parenchymal transection is performed under intermittent clamping by the Pringle maneuver. Drains are always inserted and a chest tube is inserted in patients undergoing thoracophrenolaparotomy. |
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| Study Group/Cohort (s) | Multiple Bilobar CLM
Patients selected for hepatectomy because carrier of multiple (> or = to 4), bilobar CLM
Intervention: Procedure: Hepatectomy |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 58 | ||||
| Completion Date | July 2012 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Those patients considered resectable and presenting 4 or more CLM, involving both liver lobes are systematically approached in a one stage operation. Exclusion Criteria: Patients carriers of more than 3 lung metastases, and/or diffuse peritoneal carcinomatosis, and/or extra-hilar lymph node metastasis |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01683357 | ||||
| Other Study ID Numbers ICMJE | MTX-1STAGE LONG-TERM | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Prof. Guido Torzilli, University of Milan | ||||
| Study Sponsor ICMJE | University of Milan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Milan | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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