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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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19 February 2015 |
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Main ID: |
NCT02215577 |
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Date of registration:
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11/08/2014 |
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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 Versus PVE/PL
LIGRO |
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Scientific title:
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Comparison of Two Different Models of Liver Growth Stimulation in Advanced Colorectal Liver Metastatic Disease, (LIGRO Trial) Enabling Liver Resection |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02215577 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Norway
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Sweden
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Contacts
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Name:
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Per Sandstrom, MD, PhD |
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Address:
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Telephone:
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+46 73 4058581 |
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Email:
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per.sandstrom@liu.se |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. By liver tumor board found accepted for inclusion
2. Patients with a tumor burden of colorectal liver metastasis
3. Signed informed content
4. Colorectal liver metastatic disease with an estimated FLR/sTLV of <30%
5. Primary tumor and any extrahepatic disease possible to resect in patients with liver
first approach or after resection of primary tumor.
Exclusion Criteria:
1. Cirrhosis
2. Significant comorbidity rendering subjects unsuitable for major surgery
3. Progressive disease after preoperative oncological treatment
4. Age<18 years
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Liver Metastases
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Intervention(s)
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Procedure: In-situ split
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Procedure: Portal embolization or ligation
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Primary Outcome(s)
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Surgical success rate, the rate of liver resection in each study arm
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Liver growth rate
[Time Frame: At one week after primary intervention]
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Secondary ID(s)
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SweLiv 1-2014
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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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