- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03875690
Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial (CORTIFRENCH)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Pablo Ortega-Deballon
- Phone Number: 03 80 29 37 47
- Email: pablo.ortega-deballon@chu-dijon.fr
Study Locations
-
-
-
Dijon, France, 21079
- Recruiting
- CHU de Dijon
-
Contact:
- Pablo ORTEGA-DEBALLON
- Phone Number: 0380293747
- Email: pablo.ortega-deballon@chu-dijon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
|
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.
electrolyte panel and glycemia performed within the first 24 hours after surgery.
|
Placebo Comparator: Control group
|
electrolyte panel and glycemia performed within the first 24 hours after surgery.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
frequency of patients with postoperative major complications occurring within 30 days after surgery
Time Frame: Through study completion, an average of 5 years
|
Through study completion, an average of 5 years
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- ORTEGA PHRCK 2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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