Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy (THEFLOW)

Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy-THEFLOW Study

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.

Study Overview

• Status: Unknown
• Conditions: Major Hepatectomy

Detailed Description

Liver resection is an efficient treatment for primary and secondary hepatic tumors and increases long term survival. Improvements in patient selection criteria, surgical methods, and postoperative care have increased the indications for major and extended hepatectomy (EH). Post-hepatectomy liver failure (PHLF) is a major complication following EH and is called small for size and flow syndrome (SFSF). SFSF significantly increases morbidity and mortality. The current SFSF treatments are not effective because tissue damage following SFSF is irreversible and the liver parenchyma loses the ability to regenerate. The best approach to improve patient survival is to predict SFSF and perform adequate preventive procedures during liver resection. SFSF is caused by changes in trans-hepatic flow and a low future liver remnant volume. Portal vein flow (PVF), hepatic artery flow (HAF), and portal vein pressure (PVP) are the main criteria for SFSF development. Following EH, the ratio of HAF to the remnant liver weight (HAF/100gr) decreases, while the PVF/100gr and the PVP increase. This has various pathologic consequences, which lead to SFSF. Troisi et al. suggested an upper limit of 250 ml/min/100g for PVF to prevent SFSF after living donor liver transplantation. A vascular modulation that decreases the PVF/100gr and PVP and increases the HAF/100gr may prevent SFSF. The mechanisms that alter trans-hepatic flow after hepatectomy and living donor transplantation are similar, but the effect of these changes on SFSF has not been studied following liver resection. Exploring the changes in trans-hepatic flow after major and extended hepatectomy and determining the factors that influence these changes would allow us to modulate hepatic inflow during hepatectomy to prevent PHLF.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Mohammad Golriz, MD; Phone Number: 004962215638948; Email: Mohammad.Golriz@med.uni-heidelberg.de

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Recruiting
      • Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients underwent Major hepatectomy

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Portal vein flow	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of morbidity	Based on the Clavien-Dindo classification	Three months
Rate of mortality	All cause death events	Three months
Portal vein pressure	Vein pressure (mmHg)	One day
Hepatic artery flow		One day
Central vein pressure	Vein pressure (mmHg)	One day
Mean arterial pressure		One day
Post-hepatectomy liver failure	Based on the ISGLS criteria	Three months
Grade of liver stiffness	Via fibroscan before and after resection	Three months

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Mohammad Golriz, MD, Department of General, Visceral and Transplant Surgery, University Hospital; Study Director: Arianeb Mehrabi, MD, Department of General, Visceral and Transplant Surgery, University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Mortality; Hepatectomy; Post-hepatectomy liver failure; Trans-hepatic flow
• Other Study ID Numbers: S-576/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No