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

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Active, not recruiting

Phase 3

Conditions

Elective Surgery for Any Digestive Cancer

Treatments

Drug: Injection of sodium chloride

Drug: Injection of methylprednisolone

Biological: Blood samples

Study type

Interventional

Funder types

Other

Identifiers

NCT03875690

ORTEGA PHRCK 2017

Details and patient eligibility

About

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.

Enrollment

1,200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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