NCT03371537

Brief Summary

Hepatocellular insufficiency is a dreaded complication after hepatectomy, since, if it is persistent, it leads to the death of the patient in the absence of liver transplantation. The preoperative evaluation aims in particular to estimate the risk of postoperative hepatocellular insufficiency so as to minimize or contraindicate high-risk patients. It has been shown that the flow of the portal vein is correlated with liver function, especially in the living donor and after portal embolization. More recently, the study of flow rates in the portal vein and the hepatic artery after transplantation has shown a correlation with the recovery of graft function. The hypothesis is that portal and arterial flow after hepatectomy can predict postoperative hepatocellular function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2019

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

December 8, 2017

Last Update Submit

March 17, 2021

Conditions

Liver DysfunctionCirculatory; Change

Outcome Measures

Primary Outcomes (1)

  • Liver vessel debit

    Mesure of liver debit during hepatectomy

    Baseline

Study Arms (1)

Hepatectomy

Patient undergoing laparotomy for liver resection. The aim is to measure the flow rates in the portal vein and the hepatic artery.

Procedure: Liver debit measure

Interventions

Liver debit measurePROCEDURE

Mesure of liver debit during hepatectomy

Hepatectomy

Eligibility Criteria

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

Patient undergoing laparotomy for liver resection

You may qualify if:

  • patient 18 years or more
  • Patient undergoing laparotomy for liver resection

You may not qualify if:

  • Patient under tutorship or curatorship
  • Pregnant or lactating woman
  • Difficulties in understanding French
  • Patient operated by laparoscopy
  • Patient having objected to the processing of his data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Digestive, Oncologique, Endocrinienne et Transplantation Hépatique, CHRU de TOURS

Tours, 37044, France

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Ephrem SALAME, MD-PhD

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 13, 2017

Study Start

October 8, 2017

Primary Completion

March 19, 2019

Study Completion

March 19, 2019

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

FR(1)