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Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial (CORTIFRENCH)

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ClinicalTrials.gov Identifier: NCT03875690
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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
Elective Surgery for Any Digestive Cancer Drug: Injection of methylprednisolone Drug: Injection of sodium chloride Biological: Blood samples Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: Experimental group 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.

Placebo Comparator: Control group 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.




Primary Outcome Measures :
  1. frequency of patients with postoperative major complications occurring within 30 days after surgery [ Time Frame: Through study completion, an average of 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • on course viral disease (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875690


Contacts
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Contact: Pablo Ortega-Deballon 03 80 29 37 47 pablo.ortega-deballon@chu-dijon.fr

Locations
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France
Chu de Dijon Recruiting
Dijon, France, 21079
Contact: Pablo ORTEGA-DEBALLON    0380293747    pablo.ortega-deballon@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03875690     History of Changes
Other Study ID Numbers: ORTEGA PHRCK 2017
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents