Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Follow… (NCT04965311) | Clinical Trial Compass
TerminatedPhase 2
Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy
Stopped: low enrollment
United States4 participantsStarted 2023-03-01
Plain-language summary
This phase II trial studies the effect of botulinum toxin (Botox) in preventing postoperative pancreatic fistula after distal pancreatectomy. Postoperative pancreatic fistula (POPF) is a known risk of distal pancreatic surgery, in which leakage of pancreatic digestive liquids causes internal swelling that can be painful (termed inflammation). A valve-like muscle, called the Sphincter of Oddi, opens and closes, controlling the flow of digestive liquids from the liver (bile) and pancreas (pancreatic juice) to the small intestine (duodenum). After surgery, the Sphincter of Oddi may act to block the flow of normal pancreatic secretions, causing secretions to leak into the abdomen resulting in POPF. Botox is a drug that can cause paralysis of muscles. Giving an injection of Botox into the sphincter of Oddi before distal pancreatic surgery may reduce leakage of digestive fluids and potential POPF.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant scheduled for elective distal pancreatectomy or radical antegrade modular pancreatosplenectomy (RAMPS), via open or laparoscopic technique
* Participant \>= 18 years of age
* Ability to understand nature and individual consequences of clinical trial
* Written informed consent from participant or legally authorized representative
* For participants of childbearing potential, a negative pregnancy test and adequate contraception until 14 days after trial intervention
Exclusion Criteria:
* Known hypersensitivity to any BTX preparation or to any of the components in the formulation
* Infection at the proposed injection site, including cholangitis
* Anatomy incompatible with planned intervention (e.g., Roux-en-Y gastric bypass, distal gastrectomy with Roux-en-Y or Billroth II reconstruction)
* Acute pancreatitis within 2 weeks of planned study intervention
* American Society of Anesthesiologists (ASA) score \> III
* Serious cardiovascular disease (e.g., myocardial infarction in the past year, New York Heart Association \[NYHA\] III/IV congestive heart failure, unstable angina)
* Creatinine clearance \< 30 mL/min
* Liver cirrhosis (of any Child-Pugh grade)
* Neuromuscular or any neurological disease with associated increased risk for a participant undergoing BTX injection
* Prior BTX administration
* Inability to obtain informed consent due to comprehension or language barrier
* Inability to comply with study and/or follow-up procedures
* Pregnan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Clinically Relevant Postoperative Pancreatic Fistula (POPF)