ALPPS Versus PVE/PL (LIGRO)
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|ClinicalTrials.gov Identifier: NCT02215577|
Recruitment Status : Unknown
Verified August 2014 by Regionalt Cancercentrum Väst.
Recruitment status was: Recruiting
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Study Title Comparison of two different models of liver growth stimulation in advanced colorectal liver metastatic disease, (LIGRO Trial) enabling liver resection
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Liver Metastases||Procedure: In-situ split Procedure: Portal embolization or ligation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Two Different Models of Liver Growth Stimulation in Advanced Colorectal Liver Metastatic Disease, (LIGRO Trial) Enabling Liver Resection|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2018|
Experimental: In-situ split with portal vein ligature
In-situ liver split at time when portal vein ligature is performed
Procedure: 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.
Other Name: ALPPS
Active Comparator: 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
Procedure: Portal embolization or ligation
Portal vein embolization is performed according to the intervention used at the different sites.
- Surgical success rate, the rate of liver resection in each study arm [ Time Frame: 8 weeks ]
For both the ALPPS and the portal vein embolization/ligation arm, resection is not allowed within the study if the patient is not reaching a future liver remnant of 30%.
For both groups carcinomatosis or more metastases making aiming radical resections impossible will be seen as failures.
- Liver growth rate [ Time Frame: At one week after primary intervention ]Liver growth is measured with regard to the future liver remnant by measuring the kinetic growth rate by performing repeated CT or MRI at one week after portal vein embolization/ligation or after the first step of the ALPPS procedure.
- Radical resection rate [ Time Frame: 8 weeks ]Radical resection at resection line according to histopathology
- Composite complication rate [ Time Frame: 1 month after final surgery ]Overall complications will be analysed as a composite endpoint (CEP) including: ascites, postresectional liver failure, bile leak, intra abdominal bleeding, intraabdominal abscess and mortality, all with a Clavien score of at least 3
- Treatment time [ Time Frame: 8 weeks ]Treatment time in days from PVE/PL or date of ALPPS op 1 until date of leaving hospital after final surgery.
- Progression free survival [ Time Frame: 24 months ]Progression free survival according to randomization group.
- Overall survival [ Time Frame: Up to 24 months after last inclusion ]Overall survival after inclusion
- Quality of life [ Time Frame: 24 months post final resection ]Quality of life is measured by EORTC QLQ C-30 EQ5D ar 1,6,12,24 months.
- Health economy [ Time Frame: At 8 weeks ]An analysis with regard to hospitalisation rate and number of days in-ward between randomization arm.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215577
|Contact: Per Sandstrom, MD, PhD||+46 73 email@example.com|
|Contact: Magnus Rizell, MD, Phdfirstname.lastname@example.org|
|Departments of Surgical Gastroenterology and Transplantation||Recruiting|
|Principal Investigator: Peter Noergard Larsen, PhD|
|Rikshospitalet Oslo University Hospital||Recruiting|
|Contact: Bard Rosak, MD, PhD email@example.com|
|Principal Investigator: Bard Rosok, MD, PhD|
|Sahlgrenska University Hospital||Recruiting|
|Contact: Magnus Rizell|
|Principal Investigator: Magnus Rizell, MD, PhD|
|Department of Surgery, Linkoping University Hospital||Recruiting|
|Contact: Per Sandstrom, PhD, MD|
|Principal Investigator: Per Sandstrom, MD, PhD|
|Department of Surgery, University Hospital||Recruiting|
|Contact: Gert Lindell, MD, PhD +46707190077 Gert.Lindell@skane.se|
|Principal Investigator: Gert Lindell, MD, PhD|
|Karolinska University Hospital||Recruiting|
|Contact: Bengt Isaksson, MD, PhD|
|Principal Investigator: Bengt Isaksson, MD, PhD|
|Norrland University Hospital||Recruiting|
|Contact: Bjarne Andnor, MD|
|Principal Investigator: Bjarne Andnor, MD|