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Steroid shot during surgery may cut cancer recovery risks

NCT ID NCT03875690

Disease control Sponsor: Centre Hospitalier Universitaire Dijon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether a single high dose of the steroid methylprednisolone, given during surgery, can reduce major complications in 1200 people undergoing elective surgery for digestive cancers. The goal is to calm harmful inflammation that can worsen outcomes. Results will compare complication rates within 30 days between the steroid and placebo groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methylprednisolone (a corticosteroid)
What this could lead to
If it works, this could reduce serious complications after digestive cancer surgery, potentially improving recovery and survival.
What could go wrong
This is a single high-dose treatment, not a cure. It may not reduce complications as hoped, and corticosteroids have known risks like infection or blood sugar issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2019

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

digestive system cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Elective surgery for any digestive cancer

Contacts and locations

Locations

  • Chu de Dijon

    Dijon, 21079, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.