Image

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

Recruiting
18 years of age
Both
Phase 3

Powered by AI

Overview

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.

Eligibility

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 details

Elective Surgery for Any Digestive Cancer

NCT03875690

Centre Hospitalier Universitaire Dijon

26 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.