ALPPS Versus PVE/PL (LIGRO)

Regionalt Cancercentrum Väst

Status: Unknown

Conditions: Liver Metastases; Colorectal Cancer

Treatments: Procedure: In-situ split; Procedure: Portal embolization or ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT02215577

SweLiv 1-2014

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

In-situ split with portal vein ligature

Experimental group

Description:

In-situ liver split at time when portal vein ligature is performed

Treatment:

Procedure: In-situ split

Portal embolization or ligation

Active Comparator group

Description:

Intervention: Preoperative portal embolization (+/-ablation) followed by liver resection, or local resections and/or ablations followed by lobectomy, two-stage hepatectomy

Treatment:

Procedure: Portal embolization or ligation