Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-situ split with portal vein ligature | Experimental | In-situ liver split at time when portal vein ligature is performed |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-situ split | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At one week after primary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Radical resection rate | Radical resection at resection line according to histopathology | 8 weeks |
| Composite complication rate | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Per Sandstrom, MD, PhD | Contact | +46 73 4058581 | per.sandstrom@liu.se | |
| Magnus Rizell, MD, Phd | Contact | +46705259301 | magnus.rizell@surgery.gu.se |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departments of Surgical Gastroenterology and Transplantation | Recruiting | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35129514 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D008026 | Ligation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Portal embolization or ligation | Procedure | Portal vein embolization is performed according to the intervention used at the different sites. |
|
| 1 month after final surgery |
| Treatment time | Treatment time in days from PVE/PL or date of ALPPS op 1 until date of leaving hospital after final surgery. | 8 weeks |
| Progression free survival | Progression free survival according to randomization group. | 24 months |
| Overall survival | Overall survival after inclusion | Up to 24 months after last inclusion |
| Quality of life | Quality of life is measured by EORTC QLQ C-30 EQ5D ar 1,6,12,24 months. | 24 months post final resection |
| Health economy | An analysis with regard to hospitalisation rate and number of days in-ward between randomization arm. | At 8 weeks |
| Rikshospitalet Oslo University Hospital | Recruiting | Oslo | Norway |
|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Sweden |
|
| Department of Surgery, Linkoping University Hospital | Recruiting | Linköping | Sweden |
|
| Department of Surgery, University Hospital | Recruiting | Lund | Sweden |
|
| Karolinska University Hospital | Recruiting | Stockholm | Sweden |
|
| Norrland University Hospital | Recruiting | Umeå | Sweden |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |