A Phase 2 interventional study of Liver preparation before major hepatectomy in Liver Metastasis Colon Cancer, sponsored by University Hospital, Montpellier. Completed at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by University Hospital, Montpellier · Phase 2, Interventional, and Treatment
The hypothesis is that liver venous deprivation (LVD) could strongly improve hypertrophy of the future remnant liver (FRL) at 3 weeks, as compared to portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.
Portal vein embolization (PVE) has been widely used to generate hypertrophy of the nonembolized lobe in patients undergoing major hepatectomy in order to prevent small-for-size remnant liver resulting in post-operative liver insufficiency.
Although PVE is a safe and effective procedure, it does not always induce sufficient hypertrophy of the future remnant liver (FRL) even after a long time. In case of insufficient liver regeneration following PVE, some authors suggested to embolize hepatic vein(s) (Hwang, Ann Surg 2009).
Interestingly, the sequential right hepatic vein embolization (HVE) after right PVE demonstrated an incremental effect on the FRL. Although attractive, this approach requires two different procedures and does not spare time as compared to PVE alone.
To shorten and optimize the phase of liver preparation before surgery,the so-called liver venous deprivation (LVD) technique that combines both PVE and HVE during the same procedure was developed.
The aim of this randomized phase II trial is to compare the percentage of change in FRL volume at 3 weeks after LVD or PVE using MRI or CT-scan.
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 64 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 226 are open to participants now.
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Patients whose biological parameters are :
Exclusion criteria
Liver preparation before major hepatectomy : portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.
Procedure: Liver preparation before major hepatectomy
Liver preparation before major hepatectomy : Patients with the liver venous deprivation (LVD) technique that combines both PVE and hepatic vein embolization (HVE) during the same procedure.
Procedure: Liver preparation before major hepatectomy
Simultaneous portal and hepatic vein embolization versus Portal vein embolization, also called venous deprivation OR portal vein embolization.
increase in volume of the future remnant liver (FRL)
The primary outcomes is to compare the increase in volume of the future remnant liver (FRL)
Time frame: at 3 weeks after liver venous deprivation (LVD) or portal vein embolization (PVE) using MRI or CT-scan
Tolerance
Toxicities are evaluated according to NCI-CTCAE version 4.03 published 14 June 2010
Time frame: between the day of liver preparation and 90 days after surgery
Post-operative mortality
Post-operative mortality defined as any death within 90 days after surgery or within the hospital stay
Time frame: 90 days after surgery
Post-operative morbidity
Post-operative morbidity defined as the percentages of grade I/II/III/IV/V complications according to Clavien-Dindo classification within the 90 days after surgery or within the hospital stay.
Time frame: 90 days after surgery
Post-hepatectomy liver failure
Post-hepatectomy liver failure defined according to the "50-50" criteria or peak bilirubin \>7mg/dL.
Time frame: between the day of the surgery and 90 days after surgery
Rate of non-resectability due to insufficient FRL
Rate of non-resectability due to insufficient FRL defined as the percentage of patients for whom resection will be not attempted due to insufficient FRL
Time frame: between the day of the treatment and the day of the surgery
Rate of non-resectability due to tumor progression
Rate of non-resectability due to tumor progression defined as the percentage of patients for whom resection will not be attempted due to tumor progression.
Time frame: between the day of the treatment and the day of the surgery
Rate of per-operative difficulties
Rate of per-operative difficulties defined as the percentage of patients for whom per-operative difficulties are encountered by the surgeon
Time frame: between the day of the surgery and 90 days after surgery
Blood loos, operating time, transfusion
Blood loss are evaluated in mL. Operating time avec evaluated in minutes and transfusion are evaluated by number of packed red blood cells
Time frame: the day of the surgery
R0 resection rate
Rate of R0 resection defined as no microscopic tumor residual
Time frame: the day of the surgery
R1 resection rate
Rate of R1 resection defined as the percentage of patients resected with margin \<1mm
Time frame: the day of the surgery
Pre and post-operative liver volumes
Pre and post-operative liver volumes will be evaluated through CT or MRI acquisitions by calculating whole liver, tumor and FRL volumes
Time frame: Baseline, week 1, week 3 then every 2 weeks until surgery or week 7 and 4 weeks after surgery
Recurrence-free survival
Recurrence-free survival defined as the time from date of randomization to date of recurrence or death from their tumor. Patients alive will be censored at the date of last news.
Time frame: 90 days after surgery
Overall survival
Overall survival defined as the time from date of randomization to date of death from any cause. Patients alive will be censored at the date of last news.
Time frame: Between the liver preparation and 90 days after surgery
Evaluation of pre and post-operative liver function
Evaluation of pre and post-operative liver function will be evaluated using 99mTc mebrofenine scintigraphy through SPECT/CT acquisitions by calculating mebrofenin clearance in %/min/m² of whole liver and FRL at the same time points as CT/MRI
Time frame: Baseline, week 1, week 3 then every 2 weeks until surgery or week 7 and 4 weeks after surgery
To search for biomarkers predictive of liver hypertrophy/regeneration and immune cell response
Biomarkers predictive of liver hypertrophy/regeneration are evaluated by blood samples and liver biopies
Time frame: The day of liver preparation, on day 1, day 2 and day 3 after liver preparation and the day of surgery
Ran from Apr 2019 to primary completion in Oct 2024, 65 months.
Of 476 non-industry phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 72. This study's 65 months is above that.
Counting every sponsor, half of 584 studies reached it within 47 months; a quarter within 30 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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