Botox Injection for Preventing Pancreatic Fistula After Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: OHSU Knight Cancer Institute
Disqualifiers: Hypersensitivity to BTX, Infection, Serious cardiovascular disease, Neuromuscular disease, others
No Placebo Group
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the drug Botulinum Toxin Type A in preventing pancreatic fistula after surgery?
Research suggests that injecting botulinum toxin into the sphincter of Oddi before surgery can significantly reduce the rate of pancreatic fistula, a common and serious complication after pancreatic surgery.
12345Is Botox safe for preventing pancreatic fistula after surgery?
Botox (Botulinum Toxin Type A) has been used in various medical treatments and is generally considered safe, but there have been reports of serious side effects like difficulty swallowing, muscle weakness, and breathing problems when used for cosmetic purposes. The safety of Botox for preventing pancreatic fistula is still being studied, and early trials are looking into its safety and effectiveness for this specific use.
13467How does the drug Botox prevent pancreatic fistula after surgery?
Botox is injected endoscopically into the sphincter of Oddi (a muscle controlling the flow of digestive juices) before surgery to prevent pancreatic fistula, a common complication after pancreatic surgery. This approach is unique because it targets the muscle to reduce pressure and leakage, unlike other treatments like octreotide, which have shown mixed results.
12345Eligibility Criteria
Adults scheduled for elective distal pancreatectomy or RAMPS who can understand the trial and consent to it. They must not be pregnant, have a negative pregnancy test, and use contraception until 14 days post-intervention. Exclusions include hypersensitivity to Botox, infection at injection site, recent acute pancreatitis, severe anesthesia risk (ASA score > III), liver cirrhosis, comprehension barriers, non-compliance risks, neuromuscular diseases increasing BTX risks.Inclusion Criteria
I am 18 years old or older.
I understand what joining this clinical trial means for me.
Written informed consent from participant or legally authorized representative
+2 more
Exclusion Criteria
I have previously received Botox treatments.
Your kidneys are not working well enough, based on a test called creatinine clearance.
Pregnancy or lactation
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-operative Treatment
Patients receive botulinum toxin type A via endoscopic injection into intraduodenal sphincter of Oddi segment
1-2 weeks
1 visit (in-person)
Surgery
Planned distal pancreas resection
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
2 visits (in-person)
Participant Groups
The trial is testing if injecting Botulinum Toxin Type A (Botox) into the Sphincter of Oddi before surgery can prevent pancreatic fistula by reducing digestive fluid leakage after a distal pancreatectomy. It's a phase II study aiming to see how effective this intervention is in preventing complications.
1Treatment groups
Experimental Treatment
Group I: Treatment of POPF (botulinum toxin type A)Experimental Treatment1 Intervention
Patients receive botulinum toxin type A via endoscopic injection into intraduodenal sphincter of Oddi segment between 7-14 days prior to planned distal pancreas resection.
Botulinum Toxin Type A is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Botox for:
- Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Temporary improvement in the appearance of moderate to severe facial wrinkles and folds
- Axillary hyperhidrosis
- Blepharospasm
- Strabismus
- Cervical dystonia
- Chronic migraine
- Overactive bladder
- Detrusor overactivity associated with a neurologic condition
🇪🇺 Approved in European Union as Botox for:
- Glabellar lines
- Facial wrinkles and folds
- Axillary hyperhidrosis
- Blepharospasm
- Strabismus
- Cervical dystonia
- Chronic migraine
- Overactive bladder
- Detrusor overactivity associated with a neurologic condition
- Spasticity of the upper limb
🇨🇦 Approved in Canada as Botox for:
- Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Temporary improvement in the appearance of moderate to severe facial wrinkles and folds
- Axillary hyperhidrosis
- Blepharospasm
- Strabismus
- Cervical dystonia
- Chronic migraine
- Overactive bladder
- Detrusor overactivity associated with a neurologic condition
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
OHSU Knight Cancer InstitutePortland, OR
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Who Is Running the Clinical Trial?
OHSU Knight Cancer InstituteLead Sponsor
Oregon Health and Science UniversityCollaborator
References
Sphincter of Oddi botulinum toxin injection to prevent pancreatic fistula after distal pancreatectomy. [2018]Postoperative pancreatic fistula represents the most important complication after distal pancreatectomy. The aim of this study was to evaluate the use of a preoperative endoscopic injection of botulinum toxin into the sphincter of Oddi to prevent postoperative pancreatic fistula (German Clinical Trials Register number: DRKS00007885).
Use of octreotide for the prevention of pancreatic fistula after elective pancreatic surgery: a systematic review and meta-analysis. [2021]To assess the effectiveness of octreotide in preventing postoperative pancreatic fistula. Pancreatic fistula is one of the most common complications after elective pancreatic surgery. Several clinical trials have evaluated the use of octreotide to prevent the development of pancreatic fistula after pancreatic surgery with conflicting recommendations.
Reproducibility of preoperative endoscopic injection of botulinum toxin into the sphincter of Oddi to prevent postoperative pancreatic fistula. [2022]A postoperative pancreatic fistula (POPF) is the most common and potentially life-threatening surgical complication in pancreatic surgery. One possible pharmacological treatment could be the endoscopic injection of botulinum toxin (BTX) into the sphincter of Oddi to prevent POPF. Promising data reported a significantly reduced rate of clinically relevant POPF. We analyzed the effect of BTX injection in our patients undergoing distal pancreatectomy (DP).
Protocol of a randomised controlled phase II clinical trial investigating PREoperative endoscopic injection of BOTulinum toxin into the sphincter of Oddi to reduce postoperative pancreatic fistula after distal pancreatectomy: the PREBOTPilot trial. [2021]Label="INTRODUCTION">Postoperative pancreatic fistula (POPF) is still the most frequently occurring and clinically relevant complication after distal pancreatectomy (DP). Preoperative endoscopic injection of botulinum toxin (BTX) into the sphincter of Oddi represents an innovative approach to prevent POPF. The aim of this project (PREBOTPilot) is to generate the first randomised controlled trial data on the safety, feasibility and efficacy of preoperative endoscopic BTX injection into the sphincter of Oddi to prevent clinically relevant POPF following DP.
Intrapyloric injection of botulinum toxin a for the treatment of persistent gastroparesis following successful pancreas transplantation. [2023]Intrapyloric injection of botulinum toxin A (BoTx) successfully improved symptoms in idiopathic and diabetic gastroparesis (DGP) refractory to medical treatment. Therefore, we used it in three pancreas transplant patients done in our institution during the last 18 months. They had severe, persistent DGP despite successful pancreas transplantation. They received 100 units of BoTx during the first injection. The clinical effect became evident within 2 weeks after the treatment, and lasted for an average of 29 weeks (range 14-44 weeks). The patients' subjective evaluation showed improvement of their symptoms and quality of life following BoTx. Patients 2 and 3 had recurrent symptoms at 44 and 24 weeks, respectively, after the first injection; they required a second dose of 90 and 80 units, respectively. They are doing well at 3 months follow-up. Intrapyloric injection of BoTx is safe and efficient. It should be considered for treating residual DGP following successful pancreas transplantation.
Botulinum toxin type A for treatment of refractory gastroparesis. [2019]The clinical efficacy and adverse reactions of botulinum toxin type A for refractory gastroparesis are discussed.
Delayed Antitoxin Treatment of Two Adult Patients with Botulism after Cosmetic Injection of Botulinum Type A Toxin. [2018]Injection of botulinum toxin type A for cosmetic purposes is common. It is believed to be safe, but adverse reactions have been reported, including dysphagia, generalized paralysis, respiratory depression, and death caused by focal injection of the toxin. Early administration of antitoxin in patients with adverse reactions is the mainstay of management, but the time window for its clinical efficacy is not well defined.