A Phase II Trial of Pre-Operative Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy

Who is this study for? Patients with Pancreatic Carcinoma
What treatments are being studied? Botulinum Toxin Type A
Status: Terminated
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Oregon
OHSU Knight Cancer Institute
Portland
Time Frame
Start Date: 2023-03-01
Completion Date: 2024-07-10
Participants
Target number of participants: 4
Treatments
Experimental: Treatment of POPF (botulinum toxin type A)
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.
Related Therapeutic Areas
Sponsors
Leads: OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University

This content was sourced from clinicaltrials.gov