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

NCT02216773 | Completed Results

• 1 other identifier: 14/LO/1123
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Resection; Cancer

Keywords

Liver hypertrophy; Liver resection; Liver metastases; Portal vein ligation; Portal vein embolization; Radiofrequency splitting

Outcome Measures

Primary Outcomes (1)

• 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.

  2 or 4 weeks post intervention (2 weeks post RALPP; 4 weeks post PVE)

Secondary Outcomes (2)

• Postoperative Liver Function Tests

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

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

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

Study Arms (2)

Portal vein embolization (PVE)

ACTIVE COMPARATOR

Patients allocated to the PVE group will receive pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They will then have their portal vein embolized radiologically once their pre-intervention investigations have been completed and reviewed by the clinical team. Post-intervention investigations (blood tests and CT scan) will take place 4 weeks after the completion of the PVE. At this point, they will be listed to receive their definitive surgical hepatectomy.

Procedure: Portal vein embolization (PVE)

Radiofrequency assisted liver partition and ligation (RALPP)

EXPERIMENTAL

Patients allocated to the RALPP group will receive pre-intervention blood tests and a contrast enhanced CT scan of the abdomen. They will then have their right portal vein surgically ligated followed by radiofrequency ablation in situ splitting of the liver. Certain patients may additionally have a tumourectomy or wedge resection of the left liver lobe if clinically indicated. The RALPP procedure will occur once the patient's pre-intervention investigations have been completed and reviewed by the clinical team. Post-intervention investigations (blood tests and CT scan) will take place 2 weeks after the completion of the RALPP. At this point, they will be listed to receive their definitive surgical hepatectomy.

Procedure: Radiofrequency assisted liver partition with portal vein ligation (RALPP)

Interventions

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

Radiofrequency assisted liver partition and ligation (RALPP)

Portal vein embolization (PVE) PROCEDURE

Portal vein embolization (PVE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to give informed consent
• Pregnancy
• WHO status 3 or 4
• New York Heart Association Classification Grade III or IV

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24670841 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Professor Long Jiao
• Organization: Imperial College London

l.jiao@imperial.ac.uk

+44 2033133937

Study Officials

• Long R Jiao, MD, FRCS

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 15, 2014
• Study Start: July 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 7, 2019
• Results First Posted: November 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)