Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2014-06-30
2018-12-31
Brief Summary
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Methodology Scandinavian Multiple Center Randomized Registry Based Clinical Trial
Study duration The planned duration of study participation for an individual subject from inclusion to follow-up are 3 years
Primary investigator:
Per Sandstrom (Linköping)
Number of subjects 100 patients randomized in a 1:1 randomization
Diagnosis and main inclusion criteria Patients with colorectal liver metastasis requiring liver resection, but are not resectable in one step because of a future liver remnant/standardized total liver volume of \< 30 % extrahepatic metastatic disease is not an exclusion criteria if they can be addressed surgically in the future
Overall goal To evaluate if the ALPPS approach is superior to PVE in enabling patients, primarily unresectable due to inadequate FLR, to be resected and reach an R0 situation with an acceptable level of complications and perioperative mortality.
To evaluate if the ALPPS approach increases the growth rate of the liver compared to portal embolization or portal ligation leading to a shorter treatment period.
In addition the investigators aim to study if ALPPS may reach these goals without detectable or improved differences in tumor activity (PFS and OS), but with a shorter recovery and a higher proportion of patients reaching R0.
Hypothesis A higher proportion of patients can be resected with ALPPS counted as rate resected compared to the previously established methods with portal ligation or embolization.
This increased resection rate will not reduce the R0 rate, or increase the rate of Clavien grade 4 complication or higher (H0).
The ALPPS approach will increase the growth rate compared to portal embolization/ligation measured one week after the primary intervention.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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In-situ split with portal vein ligature
In-situ liver split at time when portal vein ligature is performed
In-situ split
The portal branches to the diseased side should be completely divided. The bile duct to the diseased side should not be divided. The parenchyma should be transected all the way through the transection plane and place a plastic sheet on the diseased transection surface.
Portal embolization or ligation
Intervention: Preoperative portal embolization (+/-ablation) followed by liver resection, or local resections and/or ablations followed by lobectomy, two-stage hepatectomy
Portal embolization or ligation
Portal vein embolization is performed according to the intervention used at the different sites.
Interventions
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In-situ split
The portal branches to the diseased side should be completely divided. The bile duct to the diseased side should not be divided. The parenchyma should be transected all the way through the transection plane and place a plastic sheet on the diseased transection surface.
Portal embolization or ligation
Portal vein embolization is performed according to the intervention used at the different sites.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Significant comorbidity rendering subjects unsuitable for major surgery
3. Progressive disease after preoperative oncological treatment
4. Age\<18 years
18 Years
ALL
No
Sponsors
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Regionalt Cancercentrum Väst
OTHER
Responsible Party
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Locations
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Departments of Surgical Gastroenterology and Transplantation
Copenhagen, , Denmark
Rikshospitalet Oslo University Hospital
Oslo, , Norway
Sahlgrenska University Hospital
Gothenburg, , Sweden
Department of Surgery, Linkoping University Hospital
Linköping, , Sweden
Department of Surgery, University Hospital
Lund, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Norrland University Hospital
Umeå, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Magnus Rizell
Role: primary
Per Sandstrom, PhD, MD
Role: primary
Bengt Isaksson, MD, PhD
Role: primary
Bjarne Andnor, MD
Role: primary
References
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Hasselgren K, Rosok BI, Larsen PN, Sparrelid E, Lindell G, Schultz NA, Bjornbeth BA, Isaksson B, Larsson AL, Rizell M, Bjornsson B, Sandstrom P. Response to Comment on: Hasselgren K, et al ALPPS Improves Survival Compared With TSH in Patients Affected of CRLM: Survival Analysis From the Randomized Controlled Trial LIGRO. Ann Surg. 2021;273(3):442-448. Ann Surg. 2022 Nov 1;276(5):e632-e633. doi: 10.1097/SLA.0000000000005268. Epub 2021 Oct 20. No abstract available.
Other Identifiers
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SweLiv 1-2014
Identifier Type: -
Identifier Source: org_study_id
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