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NCT Number: NCT03875690

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Elective Surgery for Any Digestive Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chu de Dijon

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Injection of methylprednisolone

Drug

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.

Injection of sodium chloride

Drug

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.

blood samples

Biological

electrolyte panel and glycemia performed within the first 24 hours after surgery.

Primary outcomes

frequency of patients with postoperative major complications occurring within 30 days after surgery

Time frame: Through study completion, an average of 5 years

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: CORTIFRENCH

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2027
First posted: Mar 15, 2019
Registry last updated: Jan 20, 2026

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.