Condition category
Cancer
Date applied
08/03/2017
Date assigned
13/03/2017
Last edited
22/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hepatocellular carcinoma (HCC) is the most common type of liver cancer. This type of cancer starts in the liver (primary liver cancer). When other cancers spread to the liver it is known as secondary liver cancer. When possible, surgery is the main treatment because it still is the best options for treating primary and secondary liver cancer. As the liver is able to re-grow itself, surgeons are able to remove affected sections of the liver completely (liver resection). However, a certain amount of the liver must remain in order for the liver to re-grow. Patients who require a large section of their liver to be removed can undergo a portal vein embolization (PVE) which tries to get the liver to grow prior to a liver resection. A needle is placed through the skin into the liver and the blood vessel that has the largest amount of the tumour is embolized (cut off) by injecting an embolizing material (that is similar to glue). This tricks the liver into regrowing on the side without the tumour. After a few weeks, enough of the liver should have grown in order to have the surgery to remove the cancerous area. There are different types of materials that can be injected into the blood vessel to embolize it such as n-butyl-cyanoacrylate (NBCA) which is a liquid embolic material that usually is used as a tissue adhesive (glue). The aim of this study is to evaluate the efficacy of portal vein embolization (PVE) using n-butyl-cyanoacrylate (NBCA) through an ipsilateral approach as well as evaluate the accomplishment of liver surgery, patient out-come after hepatectomy and safety of the proposed PVE technique.

Who can participate?
Patients aged 5-75 who require a liver resection.

What does the study involve?
This study reviews the surgical outcomes of participants who have undergone a PVE and liver resection. After these procedures, participants are followed up with visits to the study centre every two weeks during the first month after the procedure and then every three months for the next five years. The follow up consists of scans of the liver and reviewing medical charts in order to assess how well the PVE worked in regrowing the liver and the overall health outcomes of the liver resection surgery.

What are the possible benefits and risks of participating?
There are no notable benefits or risks involved with participating.

Where is the study run from?
INCA - Brazilian National Cancer Institute (Brazil)

When is the study starting and how long is it expected to run for?
January 2011 to December 2016

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Jose Hugo Luz

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose Hugo Luz

ORCID ID

http://orcid.org/0000-0002-1222-850X

Contact details

INCA Brazilian National Cancer Institute
Praça da Cruz Vermelha 23
Centro
Rio de Janeiro
22251-030
Brazil
+55 (0)219 999 95225
jhugoluz@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Portal vein embolization with n-butyl-cyanoacrylate through an ipsilateral approach before major hepatectomy: single center retrospective analysis of 50 consecutive patients

Acronym

Study hypothesis

The aim of this study is to evaluate the efficacy of portal vein embolization (PVE) with the n-butyl-cyanoacrylate (NBCA) through an ipsilateral approach as well as evaluate the accomplishment of liver surgery, patient out-come after hepatectomy and safety of the proposed PVE technique.

Ethics approval

Brazilian National Cancer Institute Ethics Board, 27/01/2017, ref: 64117317.2.0000.5274

Study design

Single-center retrospective review study

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Primary and secondary liver cancer

Intervention

This retrospective review study consists of participants that have been referred to have a portal vein embolization. Participants have the procedure which includes involves an ultrasounded guided puncture of the liver to gain access to the right portal vein. The occlusion of the port vein is obtained using n-butyl-cyanoacrylate (NBCA). The participant is then observed at the hospital for 24 hours and is discharged after.

Some time after the procedure (around a few weeks) participants undergo surgery to remove part of their liver. This is done to the standard level of care.

After the PVE and the surgery participants attend the study centre every two weeks during the first month following the procedures and after again then every three months for five years (participants can attend more follow up sessions if it is required).

The study centre visits consist of follow up from the attending physicians (surgeons or interventional radiologists). The follow up visits includes undergoing Volume CT scans and reviewing medical charts to assess the success of the portal vein embolization and the hepatectomy. Participants are followed up at regular periods for five years or when it is needed.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Growth of the future liver remnant is measured using the Future Liver Remnant (FLR) volume changes, growth rate and kinetic growth rate obtained from the Volumetric Computer Tomography of the liver at one and four weeks after portal vein embolization.

Secondary outcome measures

1. Accomplishment of hepatectomy is measured using patients medical charts at weeks four to six after portal vein embolization
2. Patient out-come after hepatectomy is measured using patients medical charts at baseline, week two, week four and every three months for five years
3. Safety of the proposed PVE technique measured using patients medical charts during their hospitalization stay after portal vein embolization

Overall trial start date

01/01/2011

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with primary and secondary liver cancer treatable by hepatectomy
2. Proportion of FLR volume to the total functional liver volume (TFLV) less than 25% or less than 40% in patients with previous chemotherapy or hepatic cirrhosis.
3. Aged between five to 75 years old

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Extensive ipsilateral tumor precluding safe access to the portal vein
2. Unmanageable coagulopathy
3. Extensive extra-hepatic disease
4. Liver abscess or infection

Recruitment start date

01/02/2011

Recruitment end date

30/09/2016

Locations

Countries of recruitment

Brazil

Trial participating centre

INCA - Brazilian National Cancer Institute
Praça Cruz Vermelha 23 Centro
Rio de janeiro
20230-130
Brazil

Sponsor information

Organisation

National Cancer Institute of Brazil INCA

Sponsor details

Praça Cruz Vermelha
23 Centro
Rio de Janeiro
20230-130
Brazil

Sponsor type

Hospital/treatment centre

Website

http://www2.inca.gov.br/wps/wcm/connect/inca/portal/home

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr José Hugo Mendes Luz jluz@inca.gov.br

Intention to publish date

30/04/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28931429

Publication citations

Additional files

Editorial Notes

22/09/2017: Publication reference added.