CORTIFRENCH: Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial
Study Details
Study Description
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, 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Experimental group
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Drug: 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.
Biological: Blood samples
electrolyte panel and glycemia performed within the first 24 hours after surgery.
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Placebo Comparator: Control group
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Drug: 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.
Biological: Blood samples
electrolyte panel and glycemia performed within the first 24 hours after surgery.
|
Outcome Measures
Primary Outcome Measures
- frequency of patients with postoperative major complications occurring within 30 days after surgery [Through study completion, an average of 5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age >_18 years
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Elective surgery for any digestive cancer (except purely hepatic surgery)
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Patients operated in a curative intent
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Patients who had given their written informed consent
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Patients affiliated to a National health insurance scheme
Exclusion Criteria:
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Emergency surgery
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Pregnant or breastfeeding women
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Patients with an ongoing oral treatment by steroids
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Palliative surgery
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Exclusive liver surgery
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Concomitant hyperthermic intraperitoneal chemotherapy
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Patient with at least one contra-indication to methylprednisolone treatment :
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active infection
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on course viral disease (particularly hepatitis, herpes, chickenpox, herpes zoster)
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uncontrolled psychotic state
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hypersensitivity to methylprednisolone or to one of its excipients
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ASA grade >3
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Persons subject to a measure of legal protection (guardianship, tutorship)
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Persons subject to a court order
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Impossibility to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Chu de Dijon | Dijon | France | 21079 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire Dijon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ORTEGA PHRCK 2017