An interventional study of paracetamol and hepatic surgery in Paracetamol Causing Adverse Effects in Therapeutic Use and Hepatic Disease, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Diagnostic
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.
406 studies on the registry are indexed under Digestive System Diseases; 79 are open to participants now.
This study's enrollment of 90 is close to the median of 85 across 288 interventional studies indexed under Digestive System Diseases.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
resection greater than or equal to three hepatic segments
Drug: paracetamol · Procedure: hepatic surgery
resection less than three hepatic segments
Drug: paracetamol · Procedure: hepatic surgery
Drug: paracetamol · Procedure: hepatic surgery
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
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)
Time frame: during the 5 post-operative days
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
60mj/ml = paracetamol toxicity threshold according to Prescott diagram to 6 hours
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
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).
Time frame: 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.
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.
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.
Time frame: at 30 days
Plan to share: No
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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