Status:
ACTIVE_NOT_RECRUITING
Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Elective Surgery for Any Digestive Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT03875690
Start Date
July 2 2019
End Date
September 1 2027
Last Update
December 3 2024
Active Locations (1)
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1
Chu de Dijon
Dijon, France, 21079