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Study on Botulinum Toxin Injection to Prevent Pancreatic Fistula in Patients Undergoing Distal Pancreatectomy

Verified siteRegistered drugNo placebo
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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 studying the prevention of a condition known as postoperative pancreatic fistula, which can occur after surgery on the pancreas. A pancreatic fistula is a complication where digestive juices leak from the pancreas, potentially leading to further health issues. The study will use a treatment involving an injection of botulinum toxin, specifically a form called IncobotulinumtoxinA or NT 201, which is commonly known as XEOMIN. This treatment is being tested to see if it can help prevent the development of pancreatic fistulas after surgery.

The purpose of the study is to evaluate how effective the botulinum toxin injection is in preventing pancreatic fistulas in the three months following a type of surgery called a distal pancreatectomy. This surgery involves removing part of the pancreas and is sometimes performed with or without the removal of the spleen. Participants in the study will receive either the botulinum toxin injection or a placebo during their surgery. The study will monitor participants for any signs of pancreatic fistula and other potential complications after their surgery.

Throughout the study, researchers will observe the participants for any side effects related to the botulinum toxin injection and will assess various outcomes, such as the duration of hospital stays, any additional procedures needed, and overall recovery. The study aims to provide valuable information on whether this treatment can improve recovery and reduce complications for patients undergoing pancreatic surgery.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. The study aims to evaluate the effectiveness of an injection to prevent complications after pancreatic surgery.

  2. Step 2

    Surgery preparation

    You will undergo a procedure called distal pancreatectomy, which may include the removal of the spleen. This surgery is necessary for your condition and is part of the study.

  3. Step 3

    Injection administration

    During the surgery, an injection of botulinum toxin will be administered. This is intended to help prevent a complication known as a pancreatic fistula, which can occur after surgery.

  4. Step 4

    Post-surgery monitoring

    After the surgery, you will be closely monitored for any signs of complications. This includes checking for fluid collections in the abdomen, delayed stomach emptying, bleeding, inflammation of the pancreas, and infections.

  5. Step 5

    Follow-up assessments

    You will have regular follow-up appointments to assess your recovery and any side effects from the injection. These assessments will continue for up to three months after your surgery.

  6. Step 6

    Quality of life evaluation

    Your quality of life will be evaluated using a questionnaire. This helps to understand the impact of the surgery and the injection on your daily life.

  7. Step 7

    Study completion

    The study is expected to conclude by August 2026. Your participation will contribute to understanding the effectiveness of the treatment in preventing post-surgical complications.

Who can join the trial?

3 criteria

  • Patients who are scheduled to have a distal pancreatectomy. This is a surgery to remove the tail of the pancreas. It can be done through open surgery or minimally invasive surgery, with or without removing the spleen.
  • Patients must be 18 years or older.
  • Both men and women can participate.

Who cannot join the trial?

3 criteria

  • Patients with a history of **pancreatic fistula** cannot participate. A pancreatic fistula is an abnormal connection that forms between the pancreas and other organs or tissues.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means individuals who may be at a higher risk of harm or exploitation.
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Investigated drugs

Botulinum Toxin is a medication used in this clinical trial. It is injected into the pancreas to help prevent a complication called a pancreatic fistula, which can occur after surgery to remove part of the pancreas. A pancreatic fistula is a leak of pancreatic fluid that can cause problems during recovery. By using botulinum toxin, the trial aims to reduce the chances of this complication happening after surgery.

What is already known about the treatment

Botulinum Toxin – This medication is administered through an injection directly into the papilla, which is a small opening in the pancreas. It is currently being studied in clinical trials to assess its effectiveness in preventing pancreatic fistulas, which are abnormal connections that can form after pancreatic surgery. The main therapeutic use being investigated is to prevent these fistulas after a specific type of surgery called distal pancreatectomy. At the molecular level, botulinum toxin works by blocking nerve signals that cause muscles to contract, which may help reduce the risk of fistula formation. It is classified as a neurotoxin and is commonly known for its ability to relax muscles.

Investigated diseases

Pancreatic Fistula – A pancreatic fistula is an abnormal connection that forms between the pancreas and other organs or tissues, often resulting from surgery or injury. It occurs when pancreatic fluid leaks from the pancreatic duct into surrounding areas. The condition can lead to inflammation and infection if the leaked fluid irritates nearby tissues. Over time, the fistula may cause symptoms such as abdominal pain, fever, and digestive issues. The progression of a pancreatic fistula can vary, with some cases resolving on their own while others may persist and require medical intervention. The severity of the condition is often classified based on the amount of fluid leakage and the presence of complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514929-33-00Protocol codeP170913JEstimated enrolment460 patientsSponsorAssistance Publique Hopitaux De Paris

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