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Study on Botulinum Toxin Type A to Prevent Pancreatic Fistulas 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 fistulas, which can occur after surgery on the pancreas. The pancreas is an organ in the body that helps with digestion and blood sugar regulation. A pancreatic fistula is a complication where digestive juices leak from the pancreas after surgery. The treatment being tested in this study is an injection of Botulinum toxin (BOTOX®), a substance that is commonly known for its use in cosmetic procedures but is also used in various medical treatments.

The purpose of this study is to explore whether injecting BOTOX® into a specific muscle called the sphincter of Oddi, which controls the flow of digestive juices, can safely and effectively prevent these fistulas from forming after a type of surgery called a distal pancreatectomy. This surgery involves removing part of the pancreas. The study will involve a series of steps where participants will receive the BOTOX® injection before their surgery, and researchers will monitor them to see if the treatment helps reduce the occurrence of pancreatic fistulas.

Participants in the study will undergo the BOTOX® injection before their scheduled surgery, and their recovery will be closely observed to assess the safety and feasibility of this approach. The study aims to determine if this method can be completed successfully in most patients and to evaluate its impact on reducing the risk of developing pancreatic fistulas after surgery. The findings from this study could potentially lead to improved outcomes for patients undergoing pancreatic surgery in the future.

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 study

    Eligibility is determined based on specific criteria, including being 18 years or older and having a lesion in the body or tail of the pancreas that requires a distal pancreatectomy.

    Informed consent must be signed to participate in the study.

  2. Step 2

    Preoperative preparation

    The main objective is to assess the feasibility and safety of a preoperative endoscopic injection of BOTOX® into the sphincter of Oddi.

    This step involves the administration of BOTOX®, which is a solution for injection containing botulinum toxin type A.

  3. Step 3

    Administration of BOTOX®

    The BOTOX® injection is performed endoscopically, targeting the sphincter of Oddi.

    The goal is to complete this treatment in 14 out of 15 patients to consider it feasible.

  4. Step 4

    Surgery

    Following the BOTOX® injection, a distal pancreatectomy is performed. This surgery can be open, laparoscopic, or robot-assisted.

  5. Step 5

    Postoperative monitoring

    The effect of the BOTOX® injection on the occurrence of postoperative pancreatic fistulas is monitored as a secondary endpoint.

    The study aims to determine if the injection reduces the incidence of these fistulas.

  6. Step 6

    Completion of study

    The estimated end date for the study is December 31, 2025.

    The study's primary endpoint is to confirm the feasibility and safety of the BOTOX® injection procedure.

Who can join the trial?

4 criteria

  • Must be **18 years or older**.
  • Must have a **lesion** (an abnormal area) in the **body or tail of the pancreas**. This is a part of the pancreas where surgery will be done.
  • Must be scheduled for a **distal pancreatectomy**, which is a type of surgery to remove part of the pancreas. This can be done through open surgery, laparoscopic surgery (using small cuts and a camera), or robot-assisted surgery.
  • Must have **signed informed consent**, meaning you agree to participate in the study after being told all the important details.

Who cannot join the trial?

4 criteria

  • Patients who have a condition called postoperative pancreatic fistulas cannot participate. This is a complication that can occur after surgery on the pancreas, where digestive juices leak from the pancreas.
  • 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 do not belong to the specified clinical trial group cannot participate. The study is designed for specific groups of patients.
  • Patients who are considered part of a vulnerable population cannot participate. This term refers to groups of people who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

Botulinum Toxin (BOTOX®) is being studied for its potential to prevent complications after surgery on the pancreas. In this trial, BOTOX® is injected into a specific muscle area called the sphincter of Oddi before surgery. The goal is to see if this injection can help reduce the risk of developing a pancreatic fistula, which is a common complication after certain types of pancreatic surgery. The study aims to determine if this approach is safe and practical for patients undergoing this procedure.

What is already known about the treatment

Botulinum Toxin (BOTOX®) – This medication is administered through an endoscopic injection into the sphincter of Oddi. It is currently being studied in clinical trials to assess its feasibility and safety for preventing postoperative pancreatic fistulas in patients undergoing distal pancreatectomy. The main therapeutic indication is to reduce the risk of these fistulas, which are a common complication after pancreatic surgery. At the molecular level, Botulinum Toxin works by blocking the release of neurotransmitters, leading to muscle relaxation. It is classified pharmacologically as a neuromuscular blocking agent.

Investigated diseases

Postoperative Pancreatic Fistulas – This condition occurs when an abnormal connection forms between the pancreas and other organs or tissues following surgery. It is characterized by the leakage of pancreatic fluid, which can lead to inflammation and infection in the surrounding areas. The development of a fistula can cause abdominal pain and digestive issues. Over time, the persistent leakage may result in nutritional deficiencies and require ongoing medical management. The condition is often monitored closely to prevent complications and ensure proper healing.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-517267-23-00Protocol codeNL68231.078.18Estimated enrolment50 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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