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Completed

NCT Number: NCT02216773

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hammersmith Hospital

London, W12 0HS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency assisted liver partition with portal vein ligation (RALPP)

Procedure

Portal vein embolization (PVE)

Procedure

Primary outcomes

  1. Changes in Liver Remnant Volume

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

    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.

Secondary outcomes

  1. Postoperative Liver Function Tests

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

    Blood tests

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

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

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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Liver Regeneration: a Single-centre, Prospective, Randomised Controlled Trial Comparing Radiofrequency Assisted Liver Partition With Portal Vein Ligation (RALPP) With Portal Vein Embolization (PVE) for Preoperative Induction of Liver Hypertrophy in Patients With Insufficient Future Liver Remnant Volume for Major Liver Resection.

Acronym: REBIRTH

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2014
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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