BridgeMD
Benefit of a flash dose of corticosteroids in digestive surgical oncology: a randomized, double blind, placebo-controlled trial
EU CTIS ID: 2024-513728-40-00
What this study is testing
to assess the impact of a flash dose of preoperative corticosteroids versus placebo on the onset of major complications after elective curative-intent surgery for digestive cancer
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > or = 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
You likely can't join if
- Emergency surgery
- Persons subject to a court order
- Impossibility to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
- Secondary exclusion criteria : live vaccine or live attenuated vaccine administered within 1 month preceding surgery
- Secondary exclusion criteria : cancelled surgery without deferral
- Pregnant or breastfeeding women
See the full eligibility criteria
- Age > or = 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
- Emergency surgery
- Persons subject to a court order
- Impossibility to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
- Secondary exclusion criteria : live vaccine or live attenuated vaccine administered within 1 month preceding surgery
- Secondary exclusion criteria : cancelled surgery without deferral
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.