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

Phase 3

Active, not recruiting

• Conditions: Elective Surgery for Any Digestive Cancer
• Interventions: Drug: Injection of sodium chloride; Drug: Injection of methylprednisolone; Biological: Blood samples

• Registration Number: NCT03875690
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Study Start: 2019-07-02
• Primary Completion: 2024-02-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Injection of sodium chloride	-
Control group	Blood samples	-
Experimental group	Injection of methylprednisolone	-
Experimental group	Blood samples	-

Primary Outcome Measures

Name	Time	Method
frequency of patients with postoperative major complications occurring within 30 days after surgery	Through study completion, an average of 5 years

Trial Locations

Locations (1)

Chu de Dijon; 🇫🇷 Dijon, France