Condition category
Digestive System
Date applied
17/07/2014
Date assigned
13/08/2014
Last edited
13/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Liver resection is surgical removal of a portion of the liver. It is the treatment for multiple cancerous and non-cancerous masses in the liver. After removing a part of the liver it has the ability to regenerate. In some laboratory and animal studies N-acetylcysteine, a medication commonly used in treatment of acetaminophen (a pain medicine) overdose, has shown the ability to improve liver regeneration after resection. This study will test this theory in humans.

Who can participate?
All adult patients who are undergoing a major resection of the liver.

What does the study involve?
Patients are randomly allocated to either receiving N-acetylcysteine after the liver resection or not receiving it. There are no other differences in the treatment.

What are the possible benefits and risks of participating?
The potential benefit is improved liver regeneration. Potential risks are side effects from receiving the medication.

Where is the study run from?
The Foothills Medical Center, Calgary, AB, Canada.

When is study starting and how long is it expected to run for?
The study ran from February 2007 until June 2012.

Who is funding the study?
Alberta Health Services (Canada).

Who is the main contact?
Dr Elijah Dixon
Elijah.Dixon@albertahealthservices.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elijah Dixon

ORCID ID

Contact details

Division of General Surgery
Faculty of Medicine
University of Calgary
EG - 26
Foothills Medical Centre
1403 - 29 Street NW
Calgary
AB
T2N2T9
Canada
+1 (0) 403 944 3045
elijah.dixon@albertaheathservices.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of N-acetylcysteine on liver recovery after resection: a randomized clinical trial

Acronym

Study hypothesis

The objective of this study is to determine whether N-acetylcysteine can reduce the incidence of postoperative liver dysfunction and the overall complication rate when administered following major hepatic resection (two or more Coinaud segments).

Ethics approval

Conjoint Health Research Ethics Board, University of Calgary, 18/05/2010, ref. E18866

Study design

Randomized clinical trial, single institution, non-blinded

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Decrease in liver failure after liver resection for any diagnosis

Intervention

Both randomized groups will undergo the same preoperative and intraoperative management.
The only difference in postoperative management will be use of N-acetylcysteine infusion - 150 mg/kg of NAC in 200 ml of 5% glucose over 45 minutes upon arrival in the post-anaesthesia recovery room. Then 50 mg/kg of NAC in 500 ml of 5% glucose over 4 hours, followed by 100 mg/kg in 1000 ml of 5% glucose over the next 16 hours, followed by 100 mg/kg in 1000 ml of 5% glucose per day over the next 3 days, which will be administered in six infusions of 50 mg/kg in 500 ml of 5% glucose, given over 12 hours each (intervention group only)

Intervention type

Drug

Phase

Not Applicable

Drug names

N-acetylcysteine

Primary outcome measures

Overall complication rate. These will be recorded in a prospective fashion throughout the trial. Coding will then be done according to the Clavien-Dindo classification, which is the most common description of types of complications (grade I, II, IIIa, IIIb, IVa, IVb and V).

Secondary outcome measures

Postoperative liver failure as defined by:
1. The 50-50 criterion (PT>50% (INR>1.7), bilirubin > 50 umol/l (3 mg/dL) on postoperative day 5)
2. Length of stay
3. Postoperative mortality

Overall trial start date

01/02/2007

Overall trial end date

01/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

All adult patients scheduled to undergo major hepatic resection (defined as the removal of at least two Couinaud segments) for any cause at the Foothills Medical Centre who give written informed consent are eligible for the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

460

Participant exclusion criteria

Participation in other trials before or during treatment

Recruitment start date

01/02/2007

Recruitment end date

01/06/2012

Locations

Countries of recruitment

Canada

Trial participating centre

Division of General Surgery
Calgary, AB
T2N2T9
Canada

Sponsor information

Organisation

Alberta Health Services (Canada)

Sponsor details

10101 Southport Rd SW
Calgary
AB
T2W3N2
Canada

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Alberta Health Services (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes