Clinical trial NCT03762876: Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy
Official title: Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy-THEFLOW Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Hepatectomy
Keywords: Hepatectomy
Trans-hepatic flow
Post-hepatectomy liver failure
Mortality
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent Major hepatectomy

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Portal vein flow
timeFrame: One day
Secondary outcomes:
measure: Portal vein pressure
timeFrame: One day
measure: Hepatic artery flow
timeFrame: One day
measure: Central vein pressure
timeFrame: One day
measure: Mean arterial pressure
timeFrame: One day
measure: Post-hepatectomy liver failure
timeFrame: Three months
measure: Rate of morbidity
timeFrame: Three months
measure: Rate of mortality
timeFrame: Three months
measure: Grade of liver stiffness
timeFrame: Three months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Department of General, Visceral and Transplant Surgery, University Hospital
name: Mohammad Golriz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of General, Visceral and Transplant Surgery, University Hospital
name: Arianeb Mehrabi, MD
role: STUDY_DIRECTOR
References:
citation: 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.