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Completed

NCT Number: NCT03297073

Paracetamol Metabolism Research in Postoperative Hepatic Surgery

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.

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Key information

Conditions

Paracetamol Causing Adverse Effects in Therapeutic Use Digestive System Diseases Hepatic Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Huriez, CHRU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,

Exclusion criteria

  • 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,
  • 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,

Treatment and study plan

Paracetamol

Drug

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 surgery

Procedure

Primary outcomes

  1. 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)

Secondary outcomes

  1. Dosage of urinary metabolites of paracetamol (paracetamol sulphate, paracetamol glucuronide)

    Time frame: At Day 1, day 3, day 5 post operative

  2. Dosage of N-acetyl-cysteinyl paracetamol ( NAPQI)

    Time frame: At Day 1, day 3, day 5 post operative

  3. Percentage of patients with paracetamolemia greater than 60 mg / mL

    Time frame: during the 5 post-operative days

    60mj/ml = paracetamol toxicity threshold according to Prescott diagram to 6 hours

  4. Plasma Disappearance Rate of indocyanine green (TDP-ICG) by LiMon®

    Time frame: At Day 1, day 3, day 5 post operative

  5. Rate of postoperative hepatocellular insufficiency

    Time frame: at day 5

    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).

  6. Occurrence of complications related to hepatic failure

    Time frame: at day 5

    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.

  7. Duration of hospitalization in perioperative intensive care

    Time frame: at 30 days

  8. Duration of total hospitalization.

    Time frame: at 30 days

  9. Mortality

    Time frame: at 30 days

  10. Composite characteristics of surgery.

    Time frame: at 30 days

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: PARAFOI

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 29, 2017
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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