Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

ALPPS Versus PVE/PL (LIGRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Liver Metastases Procedure: In-situ split Procedure: Portal embolization or ligation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Radical resection rate [ Time Frame: 8 weeks ]
    Radical resection at resection line according to histopathology

  2. 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

  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.

  4. Progression free survival [ Time Frame: 24 months ]
    Progression free survival according to randomization group.

  5. Overall survival [ Time Frame: Up to 24 months after last inclusion ]
    Overall survival after inclusion

  6. 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.

  7. Health economy [ Time Frame: At 8 weeks ]
    An analysis with regard to hospitalisation rate and number of days in-ward between randomization arm.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Per Sandstrom, MD, PhD +46 73 4058581 per.sandstrom@liu.se
Contact: Magnus Rizell, MD, Phd +46705259301 magnus.rizell@surgery.gu.se

Locations
Layout table for location information
Denmark
Departments of Surgical Gastroenterology and Transplantation Recruiting
Copenhagen, Denmark
Principal Investigator: Peter Noergard Larsen, PhD         
Norway
Rikshospitalet Oslo University Hospital Recruiting
Oslo, Norway
Contact: Bard Rosak, MD, PhD       brosok@ous-hf.no   
Principal Investigator: Bard Rosok, MD, PhD         
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Magnus Rizell         
Principal Investigator: Magnus Rizell, MD, PhD         
Department of Surgery, Linkoping University Hospital Recruiting
Linkoping, Sweden
Contact: Per Sandstrom, PhD, MD         
Principal Investigator: Per Sandstrom, MD, PhD         
Department of Surgery, University Hospital Recruiting
Lund, Sweden
Contact: Gert Lindell, MD, PhD    +46707190077    Gert.Lindell@skane.se   
Principal Investigator: Gert Lindell, MD, PhD         
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Bengt Isaksson, MD, PhD         
Principal Investigator: Bengt Isaksson, MD, PhD         
Norrland University Hospital Recruiting
Umea, Sweden
Contact: Bjarne Andnor, MD         
Principal Investigator: Bjarne Andnor, MD         
Sponsors and Collaborators
Regionalt Cancercentrum Väst

Layout table for additonal information
Responsible Party: Regionalt Cancercentrum Väst
ClinicalTrials.gov Identifier: NCT02215577    
Other Study ID Numbers: SweLiv 1-2014
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by Regionalt Cancercentrum Väst:
cancer, colorectal
hepatectomy
portal vein
embolization
two-stage
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases