Regeneration of Liver: Portal Vein Embolization Versus Radiofrequency Assisted Ligation for Liver Hypertrophy (REBIRTH)

Imperial College London57 enrolled

Overview

The aim of this study is to compare two different techniques (portal vein embolization and radiofrequency assisted liver partition with portal vein ligation) for increasing liver volume prior to major liver resection.

Liver resection remains the gold standard treatment for patients with liver tumours providing them the only chance for long-term survival. In up to 45% of cases that are amenable to surgical resection, an extended hepatectomy (removal of part of the liver) is usually necessary to achieve a clear resection margin. However, there must be enough liver left behind to meet the demands of the body. Indeed, liver failure due to insufficient remnant liver volume is still the principal cause of postoperative death following a major liver resection. The liver receives its main blood supply from two vessels (the portal vein and the hepatic artery). In order to decrease the complications and improve the safety of extensive liver surgery in patients with insufficient future liver remnant volume (FLRV), pre-operative embolization (i.e. blockage) of part of the portal vein can be undertaken. This has the effect of inducing growth of the liver on the unaffected side. Thus, when the resection is carried out, an increased FLRV (of around 12%) reduces post-operative liver failure. An alternative technique is to perform surgical ligation of the portal vein along with splitting of the liver. The diseased portion of liver is left in the body for 7-10 days while the healthy side is induced to grow. During this time, the diseased portion continues to support the body's requirement for liver function and reduces the risk of liver failure. FLRV has been shown to increase by around 74% with this technique. However, there are more postoperative complications with the alternative technique such as bile leaks. The aim of this study is to test a new way of splitting the liver so that the increased FLRV can be achieved without the increased complication rate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Resection Cancer

Interventions

Radiofrequency assisted liver partition with portal vein ligation (RALPP)PROCEDURE

Portal vein embolization (PVE)PROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Any patient requiring right or extended right hepatectomy with FLRV less than 25% on preoperative volumetric study * WHO performance status 0, 1 or 2 * Patient able to comply with protocol requirements and deemed fit for surgical resection * Written informed consent Exclusion Criteria: * Inability to give informed consent * Pregnancy * WHO status 3 or 4 * New York Heart Association Classification Grade III or IV

Locations (1)

Hammersmith Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Changes in Liver Remnant Volume

Percentage change in remnant liver volume following intervention. This will be measured by volumetric analysis of CT scan. Positive number represents increases and negative number represents decreases.

Time frame: 2 or 4 weeks post intervention (2 weeks post RALPP; 4 weeks post PVE)

Secondary Outcomes

Postoperative Liver Function Tests

Blood tests

Time frame: Postoperatively (daily until discharge; then at clinic appointments up to 18 months from randomization)

Number of Participants With Postoperative Complications (Dindo Clavien ≥Grade 3b)

As defined by Dindo Clavien classification of surgical complications (≥grade 3b).

Time frame: Up to hospital discharge (estimated to be between 2 and 10 days)

Data from ClinicalTrials.gov

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