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Study on the Effects of Methylprednisolone and Sodium Chloride in Patients Undergoing Surgery for Digestive Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients undergoing planned surgery for digestive cancer. The study aims to evaluate the effects of a quick dose of corticosteroids, specifically using two medications: Methylprednisolone Viatris and Solumedrol. These medications are given as an injection into a vein. The trial will compare the outcomes of patients receiving these medications to those receiving a placebo, which is a substance with no active drug.

The purpose of the study is to understand if a pre-surgery dose of corticosteroids can reduce the risk of major complications after surgery. Participants will be randomly assigned to receive either the corticosteroid treatment or a placebo before their surgery. The study will monitor the occurrence of any significant complications within 30 days after the surgery. Additionally, the study will look at other factors such as overall survival, disease-free survival, and the frequency of infections after surgery.

Throughout the study, the safety of the treatment will be closely observed, with particular attention to side effects like high blood sugar and issues with electrolytes, which are minerals in the blood that help with various body functions. The study will also assess how well surgical wounds heal by checking them 30 days after the surgery. The trial is expected to continue until November 2026, with the goal of providing valuable insights into the benefits of corticosteroids in surgical oncology for digestive cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing written informed consent and meeting the eligibility criteria, which include being 18 years or older, scheduled for elective surgery for digestive cancer (excluding purely liver surgery), and being covered by a national health insurance scheme.

  2. Step 2

    Preoperative preparation

    Before surgery, a single dose of medication is administered. This involves an intravenous infusion of methylprednisolone (500 mg) or a placebo. The infusion is prepared as a solution for injection.

  3. Step 3

    Surgery

    The surgery is performed with the intent to cure the digestive cancer. The impact of the preoperative medication on surgical outcomes is assessed.

  4. Step 4

    Postoperative monitoring

    Monitoring occurs for 30 days after surgery to observe any major complications, defined as those with a Clavien-Dindo grade greater than 2. Blood samples are taken within the first 24 hours post-surgery to check for side effects such as high blood sugar and electrolyte imbalances. Wound healing is evaluated at the 30-day follow-up.

  5. Step 5

    Follow-up assessments

    The study evaluates overall survival and disease-free survival over a period of three years. The frequency of postoperative infections and intraabdominal infections is also assessed within 30 days after surgery. The number of hospitalization days is recorded, with patients considered hospitalized until day 30 in the event of death.

Who can join the trial?

5 criteria

  • Must be **18 years old or older**.
  • Scheduled for **elective surgery** for any type of **digestive cancer**. Elective surgery means a planned surgery, not an emergency one.
  • Surgery must be intended to **cure** the cancer.
  • Must have given **written informed consent**. This means you agree to participate after being fully informed about the study.
  • Must be **affiliated with a National health insurance scheme**. This means you need to have health insurance that is recognized nationally.

Who cannot join the trial?

3 criteria

  • Patients who are not scheduled for surgery to treat **digestive cancer** cannot participate. **Digestive cancer** refers to cancer affecting parts of the digestive system, like the stomach or intestines.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups, but the exact ages are not specified here.
  • Patients who are part of a vulnerable population cannot participate. A **vulnerable population** includes groups who may have difficulty giving informed consent or are at higher risk of harm.
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Investigated drugs

Corticosteroids are medications used in this trial to evaluate their effect when given as a single, quick dose before surgery. They are being tested to see if they can help reduce the risk of major complications after surgery for digestive cancer. Corticosteroids are known for their ability to reduce inflammation and suppress the immune system, which might help in improving recovery after surgery.

What is already known about the treatment

Corticosteroids – These medications are typically administered orally or through injection and are used to reduce inflammation and suppress the immune system. In the context of the clinical trial, corticosteroids are being evaluated for their potential to reduce complications following surgery for digestive cancer. They are well-established in medical literature for their anti-inflammatory and immunosuppressive properties. The main therapeutic indication in this trial is to prevent major complications after surgery. At the molecular level, corticosteroids work by binding to glucocorticoid receptors, which then modulate the expression of specific genes that control inflammation and immune responses. They are classified as anti-inflammatory and immunosuppressive agents.

Investigated diseases

Digestive Cancer – Digestive cancer refers to a group of cancers that affect the digestive system, including the stomach, liver, pancreas, and intestines. These cancers begin when cells in the digestive organs grow uncontrollably, forming tumors. As the disease progresses, it can invade nearby tissues and spread to other parts of the body. Symptoms may vary depending on the specific organ affected but can include abdominal pain, weight loss, and changes in bowel habits. The progression of digestive cancer can lead to complications such as blockages in the digestive tract or bleeding. Early detection and management are crucial to prevent further advancement of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513728-40-00Protocol codeCORTIFRENCHEstimated enrolment1 200 patientsSponsorCentre Hospitalier Universitaire De Dijon

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