Benefit of a flash dose of corticosteroids in digestive surgical oncology: a randomized, double blind, placebo-controlled trial

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1200

Inclusion Criteria

- Age = 18 years
- Undergoing elective surgery for a 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the impact of a flash dose of preoperative corticosteroids versus placebo on the onset of major complications (Clavien-Dindo >2) within 30 days after elective curative-intent surgery for digestive cancer.;Secondary Objective: 1. EFFICACY: to assess the effect of a perioperatoive flash of corticosteroids versus placebo on :<br> - Overall survival at 3 years<br> - Disease-free survival at 3 years<br> - Postoperative infections at D30<br> - Intraabdominal infections at D30<br> - Hospital stay duration<br><br>2. SAFETY : to assess the safety of perioperative flash of corticosteroids.;Primary end point(s): Frequency of patients with major postoperative complications, occurring within 30 days after surgery (D30) and defined as all complications with Clavien-Dindo grade>2.;Timepoint(s) of evaluation of this end point: within 30 days after surgery

Secondary Outcome Measures

Name	Time	Method

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