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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centr Georges Francois Leclerc Dijon France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier De Tourcoing Tourcoing France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hopital NOVO Pontoise France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier D Auxerre Auxerre France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Centre Hospitalier Simone Veil De Beauvais Beauvais France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Cnawnu Hyugvzemtcz Uqwzweowpirxn Ritox Reims France
Ctvmch Hgiofniqzlu Rpfruqpp Dfidrowkjfkgfn Angers France
Cwbldj Hkkejnjmqvj Uuspleihpmqup Du Dbsci Dijon France
Alrmfudxgu Pgzftnxj Hnskbzfd Dk Mtmlmyuwz Marseille France
Bfcnrcru Udhmztpqth Hkwmfyra Cotvnq Besançon France
Crmy Do Nlmic Vandoeuvre Les Nancy France
Hejhmep Rcehaa Ssyfsns Vantoux France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
02.07.2019

Trial locations

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.

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 ID:
2024-513728-40-00
Protocol code:
CORTIFRENCH
Trial Phase:
Therapeutic confirmatory (Phase III)

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