Colorectal CancerLIGRONCT02215577
ALPPS Versus PVE/PL
A study testing In-situ split and Portal embolization or ligation in people with Colorectal Cancer and Liver Metastases, run by Regionalt Cancercentrum Väst at 7 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Metastases
- What is being tested?
- In-situ split and Portal embolization or ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jun 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- By liver tumor board found accepted for inclusion
- Patients with a tumor burden of colorectal liver metastasis
- Signed informed content
- Colorectal liver metastatic disease with an estimated FLR/sTLV of <30%
- Primary tumor and any extrahepatic disease possible to resect in patients with liver first approach or after resection of primary tumor.
Who cannot join
- Cirrhosis
- Significant comorbidity rendering subjects unsuitable for major surgery
- Progressive disease after preoperative oncological treatment
- Age<18 years
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Sweden5 sites, 5 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Magnus Rizell
Magnus Rizell, MD, PhD
- Recruiting
Department of Surgery, Linkoping University Hospital
Linköping
Per Sandstrom, PhD, MD
Per Sandstrom, MD, PhD
- Recruiting
Department of Surgery, University Hospital
Lund
Gert Lindell, MD, PhD, +46707190077, Gert.Lindell@skane.se
Gert Lindell, MD, PhD
- Recruiting
Karolinska University Hospital
Stockholm
Bengt Isaksson, MD, PhD
Bengt Isaksson, MD, PhD
- Recruiting
Norrland University Hospital
Umeå
Bjarne Andnor, MD
Bjarne Andnor, MD
Denmark1 site, 1 recruiting
- Recruiting
Departments of Surgical Gastroenterology and Transplantation
Copenhagen
Peter Noergard Larsen, PhD
Norway1 site, 1 recruiting
- Recruiting
Rikshospitalet Oslo University Hospital
Oslo
Bard Rosak, MD, PhD, brosok@ous-hf.no
Bard Rosok, MD, PhD
About this study
Official title: Comparison of Two Different Models of Liver Growth Stimulation in Advanced Colorectal Liver Metastatic Disease, (LIGRO Trial) Enabling Liver Resection
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
Read more
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.
- Conditions
- Colorectal Cancer, Liver Metastases
- Being tested
- In-situ split, Portal embolization or ligation
- Keywords
- cancer, colorectal, hepatectomy, portal vein, embolization, two-stage
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-situ splitProcedure or surgery
Also called ALPPS
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 ligationProcedure or surgery
Portal vein embolization is performed according to the intervention used at the different sites.
| Study group | Role | What they receive |
|---|---|---|
| In-situ split with portal vein ligature | Experimental | In-situ liver split at time when portal vein ligature is performed Receives: Procedure: In-situ split |
| Portal embolization or ligation | Active comparator | Intervention: Preoperative portal embolization (+/-ablation) followed by liver resection, or local resections and/or ablations followed by lobectomy, two-stage hepatectomy Receives: Procedure: Portal embolization or ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success rate, the rate of liver resection in each study arm
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.
Measured: 8 weeks
Secondary outcomes (1)
Liver growth rate
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.
Measured: At one week after primary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regionalt Cancercentrum Väst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215577
- Sponsor's protocol ID
- SweLiv 1-2014
- Acronym
- LIGRO
- Status last verified
- Aug 2014
- First submitted
- 11 Aug 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35129514
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Models of Liver Growth Stimulation in Advanced Colorectal Liver Metastatic Disease, (LIGRO Trial) Enabling Liver Resection
- ClinicalTrials.gov ID
- NCT02215577
- Acronym / sponsor ID
- LIGRO / SweLiv 1-2014
- Conditions
- Colorectal Cancer, Liver Metastases
- Keywords
- cancer, colorectal, hepatectomy, portal vein, embolization, two-stage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Regionalt Cancercentrum VästUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-situ split with portal vein ligature | Experimental | Procedure: In-situ splitIn-situ liver split at time when portal vein ligature is performed |
| Portal embolization or ligation | Active comparator | Procedure: Portal embolization or ligationIntervention: Preoperative portal embolization (+/-ablation) followed by liver resection, or local resections and/or ablations followed by lobectomy, two-stage hepatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- By liver tumor board found accepted for inclusion
- Patients with a tumor burden of colorectal liver metastasis
- Signed informed content
- Colorectal liver metastatic disease with an estimated FLR/sTLV of <30%
- Primary tumor and any extrahepatic disease possible to resect in patients with liver first approach or after resection of primary tumor.
Key exclusion criteria (4 listed)
- Cirrhosis
- Significant comorbidity rendering subjects unsuitable for major surgery
- Progressive disease after preoperative oncological treatment
- Age<18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-situ splitAlso: ALPPSThe 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. | Procedure or surgery | In-situ split with portal vein ligature |
| Portal embolization or ligationPortal vein embolization is performed according to the intervention used at the different sites. | Procedure or surgery | Portal embolization or ligation |
Primary outcome
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.
1 secondary outcome
Liver growth rate
Time frame: At one week after primary intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Derived from this study: PubMed 35129514Hasselgren 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-situ split and Portal embolization or ligation in people with Colorectal Cancer and Liver Metastases, run by Regionalt Cancercentrum Väst at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden, Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per Sandstrom, MD, PhD (+46 73 4058581, per.sandstrom@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success rate, the rate of liver resection in each study arm (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02215577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.