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

Deportalization, Venous Deprivation, Venous Congestion

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: NCT03995459
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

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).


Condition or disease
Malignant Liver Tumor

Layout table for study information
Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Deportalization, Venous Deprivation, Venous Congestion: Impact on Liver Volume and Function
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : May 1, 2019



Primary Outcome Measures :
  1. Change from baseline liver volume [ Time Frame: day 7, day 14 and day 21 ]
    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.

  2. Evolution from baseline of liver volume and liver function values [ Time Frame: 1 day ]
    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


Secondary Outcome Measures :
  1. Evolution from baseline of liver volume and liver function values [ Time Frame: day 7, day 14 and day 21 ]
    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

  2. Evolution from baseline of liver volume and liver function values [ Time Frame: 1 day ]
    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



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
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to the investigator's institution for major hepatectomy in a context of small FLR. Small FRL was defined as baseline FLR function (clearance rate of 99mTc-mebrofenin) <2.69%/min/m2
Criteria

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

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): NCT03995459


Locations
Layout table for location information
France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Study Director: BORIS GUIU, PU-PH University Hospital, Montpellier
Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03995459    
Other Study ID Numbers: RECHMPL19_0250
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Neoplasms
Hyperemia
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Vascular Diseases
Cardiovascular Diseases