Clinical trial NCT02216773: Regeneration of Liver: Portal Vein Embolization Versus Radiofrequency Assisted Ligation for Liver Hypertrophy (REBIRTH)
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Resection
Cancer
Keywords: Liver hypertrophy
Liver resection
Liver metastases
Portal vein ligation
Portal vein embolization
Radiofrequency splitting
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Liver Remnant Volume
timeFrame: 2 or 4 weeks post intervention (2 weeks post RALPP; 4 weeks post PVE)
Secondary outcomes:
measure: Postoperative Liver Function Tests
timeFrame: Postoperatively (daily until discharge; then at clinic appointments up to 18 months from randomization)
measure: Number of Participants With Postoperative Complications (Dindo Clavien ≥Grade 3b)
timeFrame: Up to hospital discharge (estimated to be between 2 and 10 days)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Imperial College London
name: Long R Jiao, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gall TM, Sodergren MH, Frampton AE, Fan R, Spalding DR, Habib NA, Pai M, Jackson JE, Tait P, Jiao LR. Radio-frequency-assisted Liver Partition with Portal vein ligation (RALPP) for liver regeneration. Ann Surg. 2015 Feb;261(2):e45-6. doi: 10.1097/SLA.0000000000000607. No abstract available.