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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02164292 |
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Date of registration:
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11/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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ALPPS: Safety, Feasibility and Efficacy at a Single Center
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Scientific title:
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Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS): Safety, Feasibility and Efficacy at a Single Center |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02164292 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Argentina
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Contacts
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Name:
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Eduardo de Santibañes, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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General Surgery Service, Hospital Italiano de Buenos Aires. Argentina |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with marginally resectable or primarily non-resectable locally advanced liver
tumors
- Insufficient FLR either in volume or quality
Exclusion Criteria:
- Unresectable liver metastases in the future liver remnant or unresectable extrahepatic
metastases
- Severe portal hypertension
- High anesthesiological risk
- Unresectable primary tumor
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Locally Advanced Malignant Liver Disease
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Intervention(s)
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Procedure: ALPPS
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Primary Outcome(s)
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Feasibility of the procedure defined as percentage of patients that complete both surgical stages.
[Time Frame: within 4 months after the first stage]
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Safety of the procedure defined as the incidence of postoperative complications and mortality
[Time Frame: within the first 90 days after the first stage]
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Secondary Outcome(s)
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Risk factors for morbidity
[Time Frame: within 3 month after the first stage]
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Disease-free survival and overall survival
[Time Frame: 1 and 2 years]
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Efficacy of the procedure defiend as the percentage of patients who achieve a sufficient future liver remnant hypertrophy
[Time Frame: within 10 days after the first stage]
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Risk factors for a reduced kinetic growth rate of the future liver remnant (<35 cc/day)
[Time Frame: within 3 months after the first stage]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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