Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial
NCT ID: NCT03875690
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1200 participants
INTERVENTIONAL
2019-07-02
2027-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental group
Injection of methylprednisolone
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.
Blood samples
electrolyte panel and glycemia performed within the first 24 hours after surgery.
Control group
Injection of sodium chloride
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
electrolyte panel and glycemia performed within the first 24 hours after surgery.
Interventions
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Injection of methylprednisolone
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
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
electrolyte panel and glycemia performed within the first 24 hours after surgery.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu de Dijon
Dijon, , France
Countries
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References
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Magnin J, Fournel I, Doussot A, Regimbeau JM, Zerbib P, Piessen G, Beyer-Berjot L, Deguelte S, Lakkis Z, Schwarz L, Orry D, Ayav A, Muscari F, Mauvais F, Passot G, Trelles N, Venara A, Benoist S, Messager M, Fuks D, Borraccino B, Tresallet C, Valverde A, Souche FR, Herrero A, Gaujoux S, Lefevre J, Bourredjem A, Cransac A, Ortega-Deballon P. Benefit of a flash dose of corticosteroids in digestive surgical oncology: a multicenter, randomized, double blind, placebo-controlled trial (CORTIFRENCH). BMC Cancer. 2022 Aug 23;22(1):913. doi: 10.1186/s12885-022-09998-z.
Other Identifiers
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ORTEGA PHRCK 2017
Identifier Type: -
Identifier Source: org_study_id