NCT03297073

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

December 23, 2025

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

September 25, 2017

Last Update Submit

December 16, 2025

Conditions

Hepatic DiseaseParacetamol Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (1)

  • 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)

    during the 5 post-operative days

Secondary Outcomes (10)

  • Dosage of urinary metabolites of paracetamol (paracetamol sulphate, paracetamol glucuronide)

    At Day 1, day 3, day 5 post operative

  • Dosage of N-acetyl-cysteinyl paracetamol ( NAPQI)

    At Day 1, day 3, day 5 post operative

  • Percentage of patients with paracetamolemia greater than 60 mg / mL

    during the 5 post-operative days

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

    At Day 1, day 3, day 5 post operative

  • Rate of postoperative hepatocellular insufficiency

    at day 5

  • +5 more secondary outcomes

Study Arms (3)

major hepatic surgery

EXPERIMENTAL

resection greater than or equal to three hepatic segments

Drug: paracetamolProcedure: hepatic surgery

hepatic surgery

EXPERIMENTAL

resection less than three hepatic segments

Drug: paracetamolProcedure: hepatic surgery

hepatic surgery recovery

EXPERIMENTAL
Drug: paracetamolProcedure: hepatic surgery

Interventions

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 surgeryhepatic surgery recoverymajor hepatic surgery
hepatic surgeryPROCEDURE
hepatic surgeryhepatic surgery recoverymajor hepatic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Huriez, CHRU

Lille, France

Location

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Gilles Lebuffe, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2017

First Posted

September 29, 2017

Study Start

November 20, 2016

Primary Completion

April 1, 2018

Study Completion

November 1, 2019

Last Updated

December 23, 2025

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)