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Study on Hydrocortisone for Patients Undergoing Pancreatic Surgery

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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 a surgical procedure called pancreatoduodenectomy, which is a type of surgery to remove part of the pancreas. The study is investigating the use of a medication called hydrocortisone, which is a type of steroid that can help reduce inflammation. The trial will compare the effects of hydrocortisone infusions to a placebo to see if it can improve recovery after surgery.

The purpose of the study is to assess how effective hydrocortisone is in helping patients recover from the surgery. Participants will receive either hydrocortisone or a placebo through an infusion, which is a method of delivering medication directly into the bloodstream. The study will monitor patients for any complications or improvements in their recovery process over a period of time.

Throughout the study, researchers will look for specific outcomes, such as the occurrence of a condition called post-operative pancreatic fistula, which is a complication that can happen after surgery. They will also track other potential issues like infections or delayed recovery. The goal is to determine if hydrocortisone can help reduce these risks and improve overall recovery for patients undergoing this type of surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be required to provide written informed consent. This means you agree to participate after understanding the trial's purpose and procedures.

    You must be at least 18 years old and have a planned pancreatoduodenectomy, which is a type of surgery on the pancreas.

  2. Step 2

    Pre-surgery preparation

    Before the surgery, you will be randomly assigned to receive either the hydrocortisone treatment or a placebo. A placebo is a substance with no active medication, used for comparison.

    This assignment is double-blinded, meaning neither you nor the medical staff will know which treatment you are receiving to ensure unbiased results.

  3. Step 3

    Surgery and treatment

    During the surgery, you will receive an infusion of either hydrocortisone or the placebo. An infusion is a way to deliver medication directly into your bloodstream.

    The hydrocortisone is administered as a solution for injection/infusion.

  4. Step 4

    Post-surgery monitoring

    After the surgery, you will be closely monitored for any complications, such as post-operative pancreatic fistula, which is a leakage of pancreatic fluid.

    The primary goal is to observe if the hydrocortisone treatment reduces the risk of such complications compared to the placebo.

  5. Step 5

    Follow-up period

    You will have follow-up visits for up to 90 days after the surgery to check for any complications or side effects.

    Your overall health and recovery will be assessed, including any occurrences of infections, bleeding, or other issues related to the surgery.

  6. Step 6

    Long-term observation

    Your health will be monitored for up to one year to evaluate overall survival and any long-term effects of the treatment.

    This includes checking for any serious adverse events or additional surgeries that may be required.

Who can join the trial?

4 criteria

  • Patients who are scheduled for a planned surgery called a **pancreatoduodenectomy**. This is a type of surgery to remove part of the pancreas.
  • Both male and female patients who are **18 years or older**. There is no upper age limit.
  • Patients must provide **written informed consent**. This means they agree to participate in the study after being fully informed about it, following international and local rules.
  • Patients must be able to **understand the nature of the trial** and the procedures involved, and be able to follow them.

Who cannot join the trial?

1 criterion

  • Individuals who have had a **pancreatic resection** cannot participate. This means if you have had surgery to remove part or all of your pancreas, you are not eligible.
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Investigated drugs

Hydrocortisone is a medication used in this trial to evaluate its effectiveness when given as infusions during and after surgery. It is a type of steroid that can help reduce inflammation and support the body in managing stress, especially during surgical procedures like pancreatoduodenectomy. The trial aims to see if hydrocortisone can improve recovery and outcomes for patients undergoing this type of surgery.

What is already known about the treatment

Hydrocortisone – Hydrocortisone is administered through infusions, typically given intravenously. It is currently being studied in clinical trials for its potential benefits in patients undergoing pancreatic resection, specifically pancreatoduodenectomy. The main therapeutic indication being explored is its ability to improve outcomes in surgical recovery. At the molecular level, hydrocortisone works by mimicking the effects of cortisol, a natural hormone, reducing inflammation and modulating the immune response. It is classified pharmacologically as a corticosteroid.

Investigated diseases

  • Post-operative pancreatic fistula

    This condition occurs when there is an abnormal connection that forms between the pancreas and other organs or tissues after surgery. It is characterized by the leakage of pancreatic fluid, which can lead to inflammation and infection. The severity of the fistula is graded, with grade B or worse indicating more significant complications. It typically develops within a few days to weeks following pancreatic surgery.

  • Postpancreatectomy haemorrhage

    This is a complication that can occur after the surgical removal of part or all of the pancreas. It involves bleeding that can be internal or external, and its severity is classified into grades, with grade C being more severe. The bleeding can occur immediately after surgery or be delayed, and it may require additional interventions to manage.

  • Delayed gastric emptying

    This condition is characterized by the stomach taking longer than normal to empty its contents into the small intestine. It can occur after pancreatic surgery and is graded based on severity, with grade B or worse indicating more significant delays. Symptoms may include nausea, vomiting, and a feeling of fullness.

  • Bile leak

    A bile leak occurs when bile escapes from the bile ducts into the abdominal cavity, often following surgery involving the liver or pancreas. It is graded by severity, with grade B or worse indicating more significant leakage. This can lead to abdominal pain, infection, and other complications.

  • Chyle leak

    This condition involves the leakage of lymphatic fluid, known as chyle, into the abdominal cavity after surgery. It is graded by severity, with grade B or worse indicating more significant leakage. The presence of chyle can lead to nutritional deficiencies and require dietary modifications or further interventions.

  • Postpancreatectomy acute pancreatitis

    This is an inflammation of the pancreas that occurs after surgical removal of part or all of the pancreas. It is graded by severity, with grade B or worse indicating more significant inflammation. Symptoms may include abdominal pain, nausea, and elevated pancreatic enzyme levels.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-517877-26-00Protocol codeP003623Estimated enrolment614 patientsSponsorUniversitaetsklinikum Schleswig-Holstein AöR

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