Malignant Liver Tumor Clinical Trial
Official title:
Deportalization, Venous Deprivation, Venous Congestion: Impact on Liver Volume and Function
| NCT number | NCT03995459 |
| Other study ID # | RECHMPL19_0250 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2019 |
| Est. completion date | May 1, 2019 |
| Verified date | June 2019 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Patients with multiple primary or secondary liver tumors have a low survival rate unless they
can benefit from curative extended hepatic resections with R0 or R1 marge resection.
Post-operative acute liver failure may occur after such surgery when the remnant liver is
insufficient, leading to high morbimortality.
The future remnant liver (FRL) preoperative evaluation is then the key consideration before
performing extended liver resection. The FRL volume measurement on computed tomography (CT)
imaging is the most widespread method of FRL evaluation. Threshold values of acceptable FRL
volume depend on the underlying liver function, it ranges from 20-30% in healthy liver to 40%
in cirrhotic liver. However, it recently appeared that the FRL function would be more
valuable in predicting post-operative liver failure. 99mTc-mebrofenin hepatobiliary
scintigraphy (HBS) combined with SPECT/CT enables reliable FRL function measurement with a
threshold value calculated at 2.69%/min/m2, to predict post-hepatectomy liver failure.
When the FRL evaluation does not reach the acceptable threshold values to avoid liver
failure, portal vein embolization (PVE), consisting of portal branches occlusion of the
future removed liver, can be performed. It is now the standard of care to induce FRL
regeneration before surgery. Right PVE induces right hemiliver (S5-8) deportalization (portal
input deprivation with hepatic venous drainage preservation) leading to left hemiliver (S2-4)
regeneration.
To optimize PVE results, recent effective techniques have been developed such as the
simultaneous embolization of the right portal branch and the right hepatic vein (HV), and the
right accessory HV if so, which is called liver venous deprivation technique. Additional
simultaneous embolization of the middle HV defined the extended liver venous deprivation
(ELVD) technique. ELVD induces right liver (S5-8) venous deprivation (deprivation of both
portal input and venous drainage) and leads to rapid increase in FRL function. After ELVD,
segment IV (S4) portal input from left portal branch is preserved while its venous drainage
through the middle HV is disrupted, resulting in venous congestion.
The aim of this study is to analyze the volumetric and functional evolutions after
embolization procedures in deportalized liver (S5-8 after PVE), vein-deprived liver (S5-8
after ELVD) and congestive liver (S4 after ELVD).
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | May 1, 2019 |
| Est. primary completion date | April 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: - Age > or = 18 years - primary or secondary liver tumor(s) - major hepatectomy approved by multidisciplinary tumor meeting - small FRL (baseline FLR <2.69%/min/m2) Exclusion criteria: - liver fibrosis / cirrhosis - biliary obstruction |
| Country | Name | City | State |
|---|---|---|---|
| France | Uhmontpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline liver volume | 1. Change from baseline liver volume (expressed in mL, assessed by manual regional volumetric measurements on CT) in the deportalized liver, the vein deprived liver and the congestive liver at day 7, day 14 and day 21. | day 7, day 14 and day 21 | |
| Primary | Evolution from baseline of liver volume and liver function values | Evolution from baseline of liver volume and liver function values in the deportalized liver, the vein deprived liver and the congestive liver respectively : liver function (%/min/m2): assessed by regional measurements on 99mTC-mebrofenin hepatobiliary scintigraphy | 1 day | |
| Secondary | Evolution from baseline of liver volume and liver function values | Evolution from baseline of liver volume and liver function values in the non embolized liver : liver volume (mL): assessed by manual regional volumetric measurements on CT at baseline, day 7, day 14 and day 21 | day 7, day 14 and day 21 | |
| Secondary | Evolution from baseline of liver volume and liver function values | Evolution from baseline of liver volume and liver function values in the non embolized liver : liver function (%/min/m2): assessed by regional measurements on 99mTC-mebrofenin hepatobiliary scintigraphy | 1 day |