Liver ResectionPETALSNCT01770041
Paracetamol Metabolism After Liver Surgery
An observational study of Liver Resection and Paracetamol Administration, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
This observational study will assess the metabolic pathways of paracetamol that are utilised after liver resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Resection, Paracetamol Administration
- What is being tested?
- Paracetamol (observation of routine administration)
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with benign or malignant liver tumours that have been deemed by the hepatobiliary multi-disciplinary team meetiong as requiring surgical intervention.
Who may be able to join
- Patients undergoing liver surgery
Who cannot join
- Contra-indication to paracetamol
- Inability to give written, informed consent.
- Jaundice (Bilirubin > 100 μmol/L).
- Liver resection combined with secondary surgical procedure.
- Age < 18 years.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA
About this study
Official title: Observational Study Assessing Cytochrome P450 Dependant Paracetamol Metabolites Following Liver Resection.
This observational study will assess the metabolic pathways of paracetamol that are utilised after liver resection.
Read the detailed description
Paracetamol is normally metabolised by the glucuronidation and sulfation of paracetamol to non toxic end products. If paracetamol is administered in supra-therapeutic doses this pathway becomes saturated and an alternative pathway is utilised. This results in a toxic metabolite called N-acetyl-p-benzoquinone imine (NAPQI). If NAPQI is not metabolised by glutathione to cysteine and mercapturic acid, then NAPQI bind to hepatic cells resulting in necrosis and hepatotoxicity.
Therefore the investigators plan to measure the levels of the paracetamol metabolites in patient undergoing liver resection.
Patients will undergo liver resection according to their onco-surgical requirements. As part of the normal post operative care they will receive 1g paracetamol every six hours unless stated otherwise by the operating surgeon. Urinary samples will be taken for the first 4 post operative days and used for analysis of the urinary paracetamol metabolite levels.
- Conditions
- Liver Resection, Paracetamol Administration
- Being tested
- Paracetamol (observation of routine administration)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol (observation of routine administration)Other
Also called Acetaminophen
Normal administration of paracetamol as prescribed by operating surgeon
| Study group | Role | What they receive |
|---|---|---|
| Liver resection group | Patients undergoing liver resection and receiving paracetamol (observation of routine administration) Receives: Other: Paracetamol (observation of routine administration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary cysteine
Measured: Post operative days 1-4
Secondary outcomes (3)
mercapturic acid
Measured: post operative days 1-4
Glutathione
Measured: day of surgery and post operative days 1 and 3
Paracetamol level
Measured: day of surgery and post operative days 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver ResectionStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Michael J Hughes, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770041
- Sponsor's protocol ID
- 12/SS/0222
- Acronym
- PETALS
- Status last verified
- Oct 2014
- First submitted
- 15 Jan 2013
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Assessing Cytochrome P450 Dependant Paracetamol Metabolites Following Liver Resection.
- ClinicalTrials.gov ID
- NCT01770041
- Acronym / sponsor ID
- PETALS / 12/SS/0222
- Conditions
- Liver Resection, Paracetamol Administration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study will assess the metabolic pathways of paracetamol that are utilised after liver resection.
Detailed description
Paracetamol is normally metabolised by the glucuronidation and sulfation of paracetamol to non toxic end products. If paracetamol is administered in supra-therapeutic doses this pathway becomes saturated and an alternative pathway is utilised. This results in a toxic metabolite called N-acetyl-p-benzoquinone imine (NAPQI). If NAPQI is not metabolised by glutathione to cysteine and mercapturic acid, then NAPQI bind to hepatic cells resulting in necrosis and hepatotoxicity.
Therefore the investigators plan to measure the levels of the paracetamol metabolites in patient undergoing liver resection.
Patients will undergo liver resection according to their onco-surgical requirements. As part of the normal post operative care they will receive 1g paracetamol every six hours unless stated otherwise by the operating surgeon. Urinary samples will be taken for the first 4 post operative days and used for analysis of the urinary paracetamol metabolite levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver resection group | – | Other: Paracetamol (observation of routine administration)Patients undergoing liver resection and receiving paracetamol (observation of routine administration) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with benign or malignant liver tumours that have been deemed by the hepatobiliary multi-disciplinary team meetiong as requiring surgical intervention.
Key inclusion criteria (1 listed)
- Patients undergoing liver surgery
Key exclusion criteria (6 listed)
- Contra-indication to paracetamol
- Inability to give written, informed consent.
- Jaundice (Bilirubin > 100 μmol/L).
- Liver resection combined with secondary surgical procedure.
- Age < 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol (observation of routine administration)Also: AcetaminophenNormal administration of paracetamol as prescribed by operating surgeon | Other | Liver resection group |
Primary outcome
Urinary cysteine
Time frame: Post operative days 1-4
3 secondary outcomes
mercapturic acid
Time frame: post operative days 1-4
Glutathione
Time frame: day of surgery and post operative days 1 and 3
Paracetamol level
Time frame: day of surgery and post operative days 1 and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Hughes, MBChB principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Resection and Paracetamol Administration, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary cysteine (time frame: Post operative days 1-4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.