NCT04370132

Brief Summary

before major hepatectomy, in case of insufisant future liver remanent volume or function, portal embolization is a routinely used method to enable growth of the future liver remnant. Recently liver venous deprivation has been described in some pioneer centre. The results are processing with greater and faster hypertrophy allowing probably less drop out from the embolization to surgery compared to portal embolization. In major hepatectomy, and specially in right or extended right hepatectomy the segment IV plays an important role in the proportion of future liver remnant. Despite the growing interest in the scientific community for liver venous deprivation many aspects concerning the liver hypertrophy remains unexplored. In particular the the degree of hypertrophy of segment IV after liver venous deprivation compared to portal embolization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

5.3 years

First QC Date

April 17, 2020

Last Update Submit

April 29, 2020

Conditions

Major Hepatectomy

Outcome Measures

Primary Outcomes (1)

  • segment IV degree of hypertrophy

    segment IV degree of hypertrophy

    1 day

Secondary Outcomes (2)

  • overall survival

    5 years

  • recurrence free survival

    5 years

Study Arms (2)

Group of patient with liver venous deprivation

Group of patient with liver venous deprivation

Group of patient with portal embolization

Group of patient with portal embolization

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with liver tumors selected for surgery with insufficient futur liver remnant

You may qualify if:

  • \- patient with liver tumor selected for right hepatectomy with insufficient future liver remnant who have undergoes portal embolization or liver venous deprivation

You may not qualify if:

  • \- left / extended left hepatectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Study Officials

  • Fabrizio PANARO, PhD

    UH MONTPELLIER

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 30, 2020

Study Start

January 1, 2015

Primary Completion

April 1, 2020

Study Completion

April 15, 2020

Last Updated

April 30, 2020

Record last verified: 2020-04

Locations

FR(1)