ALPPS Versus PVE/PL

Not Applicable

• Conditions: Liver Metastases; Colorectal Cancer
• Interventions: Procedure: In-situ split; Procedure: Portal embolization or ligation

• Registration Number: NCT02215577
• Lead Sponsor: Regionalt Cancercentrum Väst

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-08
• Study First Submitted: 2014-08-11
• Study First Submitted QC: 2014-08-12
• Last Update Submitted: 2014-08-12
• Study First Posted: 2014-08-13
• Last Update Posted: 2014-08-13
• Primary Completion: 2016-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
In-situ split with portal vein ligature	In-situ split	In-situ liver split at time when portal vein ligature is performed
Portal embolization or ligation	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

Primary Outcome Measures

Name	Time	Method
Surgical success rate, the rate of liver resection in each study arm	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.

Secondary Outcome Measures

Name	Time	Method
Liver growth rate	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.

Trial Locations

Locations (7)

Department of Surgery, Linkoping University Hospital; 🇸🇪 Linkoping, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Department of Surgery, University Hospital; 🇸🇪 Lund, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Norrland University Hospital; 🇸🇪 Umea, Sweden

Departments of Surgical Gastroenterology and Transplantation; 🇩🇰 Copenhagen, Denmark

Rikshospitalet Oslo University Hospital; 🇳🇴 Oslo, Norway