NCT03762876

Brief Summary

Changes in trans-hepatic flow after major and extended hepatectomy (EH) can lead to small for size and flow syndrome (SFSF), which is associated with a significantly higher rate of morbidity and mortality. The current therapies for SFSF are not effective because tissue damage following SFSF is usually irreversible and the liver parenchyma loses the ability to regenerate. Therefore, the best approach to improve patient survival is to predict SFSF and perform adequate intraoperative preventive procedures. Portal vein flow (PVF), hepatic artery flow (HAF), and portal vein pressure (PVP) are the main criteria for development of SFSF after living donor liver transplantation. The mechanisms that change trans-hepatic flow are similar after hepatectomy and living donor liver transplantation. Trans-hepatic flow is routinely measured during liver resection, but the effect of these changes on SFSF has not been studied. Identifying the factors that alter trans-hepatic flow after hepatectomy would allow hepatic inflow to be modulated before and after surgery, to prevent SFSF. Trans-hepatic flow and pressure parameters (PVF, HAF, and PVP) are routinely measured and monitored during liver resection. The aim of the proposed study is to analyze changes in these parameters after major hepatectomy and determine the factors that alter trans-hepatic flow after hepatectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 25, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

1.9 years

First QC Date

November 30, 2018

Last Update Submit

October 11, 2019

Conditions

Major Hepatectomy

Keywords

HepatectomyTrans-hepatic flowPost-hepatectomy liver failureMortality

Outcome Measures

Primary Outcomes (1)

  • Portal vein flow

    One day

Secondary Outcomes (8)

  • Portal vein pressure

    One day

  • Hepatic artery flow

    One day

  • Central vein pressure

    One day

  • Mean arterial pressure

    One day

  • Post-hepatectomy liver failure

    Three months

  • +3 more secondary outcomes

Eligibility Criteria

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

Patients underwent Major hepatectomy

You may qualify if:

  • Patient consent
  • Undergoing major or central liver resection
  • Aged above 18 years

You may not qualify if:

  • Cirrhosis
  • Previous surgery of the hepatoduodenal ligament
  • Status after transjugular intrahepatic portosystemic shunt
  • Metabolic liver diseases
  • Cardiac failure
  • Pulmonary hypertension
  • Portal vein thrombosis
  • Portal vein hypertension
  • Vascular malformation
  • Not able to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Publications (1)

  • Golriz M, Lemekhova A, Khajeh E, Ghamarnejad O, Al-Saeedi M, Strobel O, Hackert T, Muller-Stich B, Schneider M, Berchtold C, Tinoush P, Mayer P, Chang DH, Weiss KH, Hoffmann K, Mehrabi A. Evaluation of the role of transhepatic flow in postoperative outcomes following major hepatectomy (THEFLOW): study protocol for a single-centre, non-interventional cohort study. BMJ Open. 2019 Oct 11;9(10):e029618. doi: 10.1136/bmjopen-2019-029618.

    PMID: 31604785DERIVED

Study Officials

  • Mohammad Golriz, MD

    Department of General, Visceral and Transplant Surgery, University Hospital

    PRINCIPAL INVESTIGATOR

  • Arianeb Mehrabi, MD

    Department of General, Visceral and Transplant Surgery, University Hospital

    STUDY DIRECTOR

Central Study Contacts

Mohammad Golriz, MD

CONTACT

004962215638948Mohammad.Golriz@med.uni-heidelberg.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professsor, Head of the Division of Liver Surgery and Visceral Transplantation

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 4, 2018

Study Start

March 25, 2018

Primary Completion

March 1, 2020

Study Completion

July 1, 2020

Last Updated

October 15, 2019

Record last verified: 2019-10

Locations

DE(1)