Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial (CORTIFRENCH)

October 19, 2023 updated by: Centre Hospitalier Universitaire Dijon

Perioperative inflammation is harmful in cancer patients, namely in those undergoing surgery: it increases the risk of recurrence, decreases cancer survival, increases post-operative complications, and prolongs the time of recovery and the duration of hospital stay. Severe postoperative complications are also a risk factor of poor survival in cancer patients. Seemingly, some effective therapies currently used to improve the surgical outcome (e.g. immunonutrition, enhanced-recovery protocols) have an inflammatory effect. The modulation of perioperative inflammation therefore seems crucial to improve outcomes in patients undergoing surgery for digestive cancer.

A short perioperative treatment with high doses of corticosteroids has already been tested in several randomized trials. A recent meta-analysis showed that perioperative corticosteroids decreased inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery: the decrease in the risk of postoperative complications was around 50% without adverse effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >_18 years
  • Elective surgery for any digestive cancer (except purely hepatic surgery)
  • Patients operated in a curative intent
  • Patients who had given their written informed consent
  • Patients affiliated to a National health insurance scheme

Exclusion Criteria:

  • Emergency surgery
  • Pregnant or breastfeeding women
  • Patients with an ongoing oral treatment by steroids
  • Palliative surgery
  • Exclusive liver surgery
  • Concomitant hyperthermic intraperitoneal chemotherapy
  • Patient with at least one contra-indication to methylprednisolone treatment :
  • active infection
  • progressive/symptomatic viral infection (particularly hepatitis, herpes, chickenpox, herpes zoster)
  • uncontrolled psychotic state
  • hypersensitivity to methylprednisolone or to one of its excipients
  • ASA grade >3
  • Persons subject to a measure of legal protection (guardianship, tutorship)
  • Persons subject to a court order
  • Impossibility to adhere to the medical follow-up of the trial for geographical, social or psychological reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Drug: Injection of methylprednisolone
Patients will receive 20mg/kg IV of methylprednisolone at the time of anaesthetic induction. Methylprednisolone will be infused in a ready-to-use 50 mL bag of sodium chloride 0.9% during 30 minutes at anaesthesic induction.
Biological: Blood samples
electrolyte panel and glycemia performed within the first 24 hours after surgery.
Placebo Comparator: Control group
Biological: Blood samples
electrolyte panel and glycemia performed within the first 24 hours after surgery.
Drug: Injection of sodium chloride
patients in the placebo group will receive 50 mL of sodium chloride 0.9% in a ready-to-use bag during 30 minutes at anaesthesic induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
frequency of patients with postoperative major complications occurring within 30 days after surgery
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2019

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 13, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTEGA PHRCK 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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