Paracetamol Causing Adverse Effects in Therapeutic UsePARAFOINCT03297073
Paracetamol Metabolism Research in Postoperative Hepatic Surgery
A study testing paracetamol and hepatic surgery in people with Paracetamol Causing Adverse Effects in Therapeutic Use and Hepatic Disease, run by University Hospital, Lille at 1 site in France.
Trial summary
The main objective of this study was to evaluate the 5-day kinetics of plasma paracetamol levels in postoperative major hepatic surgery (resection greater than or equal to three hepatic segments) compared with less extensive liver resection and hepatic re-intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paracetamol Causing Adverse Effects in Therapeutic Use, Hepatic Disease
- What is being tested?
- paracetamol and hepatic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2016to Nov 2019
- Phase
- Interventional
- 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
Who may be able to join
- Patients requiring surgery for hepatic resection by initiation under chest or laparoscopic without hepatocellular insufficiency,
- ASA score 1 to 3 (American Society of Anesthesiologists score ranging from 1 to 5 evaluating the preoperative health status of a patient),
- Verification of the understanding of the protocol,
Who cannot join
- Patients classified ASA 4 or 5,
- Allergy or intolerance to indocyanine green
- Allergy or intolerance to paracetamol,
- Taking of paracetamol the week before the intervention,
- Patient less than 60 Kgs (because decrease of doses of paracetamol),
- Emergency surgery, palliative surgery and surgical recovery,
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- Psychic disorder,
- Contra-indication to a treatment used during the study,
- incapable major,
- Intellectual incapacity preventing proper understanding of the protocol,
- Pregnant or nursing woman,
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study was to evaluate the 5-day kinetics of plasma paracetamol levels in postoperative major hepatic surgery (resection greater than or equal to three hepatic segments) compared with less extensive liver resection and hepatic re-intervention. The clearance of indocyanine green is a marker of hepatic perfusion but also of the proper hepatocyte functioning, if hemodynamic conditions are stable.
Some patients may be operated on up to four or five times in the liver. Moreover, these patients probably present an increased risk of postoperative hepatocellular insufficiency due to a quantitative and qualitative decrease in their hepatic parenchyma. It is therefore interesting to evaluate the use of paracetamol in this situation.
- Being tested
- paracetamol, hepatic surgery
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
Paracetamol 1000 mg will be administered 30 minutes before the end of the procedure and then every 6 hours systematically at the following times: 6h / 12h / 18h / 00h.
The analgesic treatment after hepatectomy with paracetamol will be maintained for at least 5 days in all patients in parenteral form
hepatic surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| major hepatic surgery | Experimental | resection greater than or equal to three hepatic segments Receives: Drug: paracetamol; Procedure: hepatic surgery |
| hepatic surgery | Experimental | resection less than three hepatic segments Receives: Drug: paracetamol; Procedure: hepatic surgery |
| hepatic surgery recovery | Experimental | Not described Receives: Drug: paracetamol; Procedure: hepatic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosing and kinetics of paracetamolemia
this determination of the plasma paracetamol dosage on D0 (H6: 6 hours after the end of the procedure) and D1 D2 D3 D4 D5 (samples taken at 6 am each day just before the injection of paracetamol whose administration hours will be 6h 12h 18h and midnight)
Measured: during the 5 post-operative days
Secondary outcomes (10)
Dosage of urinary metabolites of paracetamol (paracetamol sulphate, paracetamol glucuronide)
Measured: At Day 1, day 3, day 5 post operative
Dosage of N-acetyl-cysteinyl paracetamol ( NAPQI)
Measured: At Day 1, day 3, day 5 post operative
Percentage of patients with paracetamolemia greater than 60 mg / mL
60mj/ml = paracetamol toxicity threshold according to Prescott diagram to 6 hours
Measured: during the 5 post-operative days
Plasma Disappearance Rate of indocyanine green (TDP-ICG) by LiMon®
Measured: At Day 1, day 3, day 5 post operative
Rate of postoperative hepatocellular insufficiency
The postoperative hepatocellular insufficiency according to the 50/50 criteria (TP <50% and bilirubinemia> 50 μmol / L on the 5th day) according to the type of hepatic resection (with or without clamping, continuous or discontinuous, duration intervention).
Measured: at day 5
Occurrence of complications related to hepatic failure
the complications related to hepatic failure not falling within the "50/50" criteria: jaundice, hepatic encephalopathy, coagulation disorders, ascites, cytolysis, cholestasis.
Other medical and surgical. Duration of hospitalization in perioperative intensive care and duration of total hospitalization.
Mortality at 30 days.
Measured: at day 5
Duration of hospitalization in perioperative intensive care
Measured: at 30 days
Duration of total hospitalization.
Measured: at 30 days
Mortality
Measured: at 30 days
Composite characteristics of surgery.
Characteristics of surgery: duration of intervention, numbers, duration and types of vascular clamping, detailed description of the type of liver resection performed, quantification of bleeding.
Measured: at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start20 Nov 2016
- Primary completionApr 2018
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paracetamol Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Lebuffe, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297073
- Sponsor's protocol ID
- 2015_61
- Other IDs
- 2016-002632-32, 2016
- Acronym
- PARAFOI
- Status last verified
- Mar 2021
- First submitted
- 25 Sep 2017
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol Metabolism Research in Postoperative Hepatic Surgery
- ClinicalTrials.gov ID
- NCT03297073
- Acronym / sponsor ID
- PARAFOI / 2015_61
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 20 Nov 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 29 Sep 2017 (actual)
- 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.
The main objective of this study was to evaluate the 5-day kinetics of plasma paracetamol levels in postoperative major hepatic surgery (resection greater than or equal to three hepatic segments) compared with less extensive liver resection and hepatic re-intervention. The clearance of indocyanine green is a marker of hepatic perfusion but also of the proper hepatocyte functioning, if hemodynamic conditions are stable.
Some patients may be operated on up to four or five times in the liver. Moreover, these patients probably present an increased risk of postoperative hepatocellular insufficiency due to a quantitative and qualitative decrease in their hepatic parenchyma. It is therefore interesting to evaluate the use of paracetamol in this situation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| major hepatic surgery | Experimental | Drug: paracetamol, Procedure: hepatic surgeryresection greater than or equal to three hepatic segments |
| hepatic surgery | Experimental | Drug: paracetamol, Procedure: hepatic surgeryresection less than three hepatic segments |
| hepatic surgery recovery | Experimental | Drug: paracetamol, Procedure: hepatic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring surgery for hepatic resection by initiation under chest or laparoscopic without hepatocellular insufficiency,
- ASA score 1 to 3 (American Society of Anesthesiologists score ranging from 1 to 5 evaluating the preoperative health status of a patient),
- Verification of the understanding of the protocol,
Key exclusion criteria (11 listed)
- Patients classified ASA 4 or 5,
- Allergy or intolerance to indocyanine green
- Allergy or intolerance to paracetamol,
- Taking of paracetamol the week before the intervention,
- Patient less than 60 Kgs (because decrease of doses of paracetamol),
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 |
|---|---|---|
| paracetamolParacetamol 1000 mg will be administered 30 minutes before the end of the procedure and then every 6 hours systematically at the following times: 6h / 12h / 18h / 00h. The analgesic treatment after hepatectomy with paracetamol will be maintained for at least 5 days in all patients in parenteral form | Drug | hepatic surgery, hepatic surgery recovery, major hepatic surgery |
| hepatic surgery | Procedure or surgery | hepatic surgery, hepatic surgery recovery, major hepatic surgery |
Primary outcome
Dosing and kinetics of paracetamolemia
Time frame: during the 5 post-operative days
this determination of the plasma paracetamol dosage on D0 (H6: 6 hours after the end of the procedure) and D1 D2 D3 D4 D5 (samples taken at 6 am each day just before the injection of paracetamol whose administration hours will be 6h 12h 18h and midnight)
10 secondary outcomes
Dosage of urinary metabolites of paracetamol (paracetamol sulphate, paracetamol glucuronide)
Time frame: At Day 1, day 3, day 5 post operative
Dosage of N-acetyl-cysteinyl paracetamol ( NAPQI)
Time frame: At Day 1, day 3, day 5 post operative
Percentage of patients with paracetamolemia greater than 60 mg / mL
Time frame: during the 5 post-operative days
Plasma Disappearance Rate of indocyanine green (TDP-ICG) by LiMon®
Time frame: At Day 1, day 3, day 5 post operative
Rate of postoperative hepatocellular insufficiency
Time frame: at day 5
Occurrence of complications related to hepatic failure
Time frame: at day 5
Duration of hospitalization in perioperative intensive care
Time frame: at 30 days
Duration of total hospitalization.
Time frame: at 30 days
Mortality
Time frame: at 30 days
Composite characteristics of surgery.
Time frame: at 30 days
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 23 Dec 2025.
- Individual participant dataSharing planned: No
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.
Gilles Lebuffe, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paracetamol and hepatic surgery in people with Paracetamol Causing Adverse Effects in Therapeutic Use and Hepatic Disease, run by University Hospital, Lille at 1 site in France.
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 3 inclusion and 11 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 23 Dec 2025. 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 France. 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?
Dosing and kinetics of paracetamolemia (time frame: during the 5 post-operative days). 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 23 Dec 2025.