Ongoing Clinical Trials for Pancreatic Fistula
There are currently 2 ongoing clinical trials investigating ways to prevent pancreatic fistula in patients undergoing pancreatic surgery. Both studies are testing botulinum toxin injections as a preventive treatment for this surgical complication. The trials are being conducted in France and the Netherlands.
Clinical trial locations
- France
- Netherlands
Study on Botulinum Toxin Injection to Prevent Pancreatic Fistula in Patients Undergoing Distal Pancreatectomy
This trial is being conducted in France and focuses on preventing pancreatic fistula, a complication where digestive juices leak from the pancreas after surgery. The study is testing whether an injection of botulinum toxin can help prevent this problem in patients undergoing distal pancreatectomy, a surgical procedure that removes part of the pancreas.
Who can participate: To join this study, you must be scheduled for a distal pancreatectomy, which may involve removal of the spleen. The surgery can be performed through open surgery or minimally invasive techniques. You must be at least 18 years old, and the trial is open to both men and women.
Who cannot participate: You cannot join this trial if you have previously had a pancreatic fistula. The study also excludes people who fall outside the specified age range and those considered part of vulnerable populations who may be at higher risk of harm.
What the trial involves: During your surgery, you will receive an injection of botulinum toxin (specifically IncobotulinumtoxinA, also known as XEOMIN) or a placebo directly into the papilla, a small opening in the pancreas. The injection aims to reduce the risk of fistula formation by blocking nerve signals that cause muscles to contract. After surgery, you will be closely monitored for three months to check for any signs of complications, including fluid collections in the abdomen, delayed stomach emptying, bleeding, inflammation, and infections. The study will also assess your quality of life and overall recovery through regular follow-up appointments. The trial is expected to conclude by August 2026.
Investigational drug: The study uses Botulinum Toxin, a medication that works at the molecular level by blocking nerve signals to muscles. While commonly known for cosmetic uses, it is being tested here specifically to prevent pancreatic fistula after surgery.
Study on Botulinum Toxin Type A to Prevent Pancreatic Fistulas in Patients Undergoing Distal Pancreatectomy
This trial is taking place in the Netherlands and is investigating whether BOTOX® injections can safely and effectively prevent pancreatic fistulas after surgery on the pancreas. The study focuses on patients scheduled for distal pancreatectomy, a procedure to remove part of the pancreas.
Who can participate: You must be 18 years or older and have a lesion (an abnormal area) in the body or tail of the pancreas that requires a distal pancreatectomy. The surgery can be performed using open, laparoscopic (small incisions with a camera), or robot-assisted techniques. You must also sign informed consent, meaning you agree to participate after understanding all the details of the study.
Who cannot participate: The trial excludes patients who already have postoperative pancreatic fistulas or those who fall outside the specified age range. People who do not fit the specific clinical trial group criteria or who are considered part of vulnerable populations, such as children, pregnant women, or those with certain disabilities, cannot participate.
What the trial involves: Before your scheduled surgery, you will receive an endoscopic injection of BOTOX® into the sphincter of Oddi, a muscle that controls the flow of digestive juices. This injection is performed using a camera-guided procedure. The study aims to successfully complete this treatment in 14 out of 15 patients to consider it feasible. After the injection, you will undergo your planned distal pancreatectomy. Following surgery, researchers will monitor you to see if the BOTOX® injection reduces the occurrence of pancreatic fistulas. The study’s primary goal is to confirm that this injection procedure is both safe and practical. The trial is expected to end by December 31, 2025.
Investigational drug: Botulinum Toxin Type A (BOTOX®) is a neuromuscular blocking agent that causes muscle relaxation by blocking the release of neurotransmitters. In this trial, it is being tested to see if it can prevent the formation of fistulas after pancreatic surgery.
Summary
Both ongoing clinical trials are exploring the same innovative approach to preventing pancreatic fistula: using botulinum toxin injections before or during surgery. While the trials are being conducted in different countries—France and the Netherlands—they share similar goals and patient populations. Both studies target patients undergoing distal pancreatectomy and use variations of botulinum toxin (IncobotulinumtoxinA in France and BOTOX® in the Netherlands). The French trial administers the injection during surgery directly into the pancreatic papilla, while the Dutch trial performs a preoperative endoscopic injection into the sphincter of Oddi. These studies reflect growing interest in finding effective preventive measures for this common surgical complication, which can significantly impact patient recovery and quality of life. If successful, these trials could lead to improved outcomes for patients undergoing pancreatic surgery.
