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NCT03762876: THEFLOW

Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy

Status unknown Last updated 15 October 2019
What this trial tests

trial in Major Hepatectomy in 50 participants. Status unknown.

Timeline
25 March 2018
Primary endpoint
1 March 2020
1 July 2020

Quick facts

Lead sponsorUniversity Hospital Heidelberg
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment50
Start date25 March 2018
Primary completion1 March 2020
Estimated completion1 July 2020
Sites1 location across Germany

Conditions studied

Sponsor

University Hospital Heidelberg

Who can join

18 and older, any sex, with Major Hepatectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Evaluation of the role of transhepatic flow in postoperative outcomes following major hepatectomy (THEFLOW): study protocol for a single-centre, non-interventional cohort study.
    Golriz M, Lemekhova A, Khajeh E, Ghamarnejad O, et al · · 2019 · PMID 31604785 · DOI 10.1136/bmjopen-2019-029618

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Other University Hospital Heidelberg trials

Trials by the same sponsor.

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