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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Lille Lille France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hopital Prive Jean Mermoz Lyon France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Bqetryzu Ufwydychsy Hqopgstx Cqakuf Besançon France
Cgcgis Haqhpbnrfmq Rgtppzei Uetupigplwsrv Dx Tyeuc Tours France
Csvj Dx Nxejc Vandoeuvre Les Nancy France
Gbbloj Hadzyfojkgv Uzelkffokdody Pblbj Plzjadsvfre Ec Nzmxdtljxrgz Paris France
Hclqaoen Uygpacgtbbygyy Snpuzarzbr &nbkzqh Hhkibko dc Hrivfyafbfv STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
France France
Recruiting
27.03.2023

Trial locations

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.

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 ID:
2024-514929-33-00
Protocol code:
P170913J
NCT ID:
NCT04220931
Trial Phase:
Therapeutic confirmatory (Phase III)

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