A Phase II Trial of Pre-Operative Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy
Trial ID: NCT04965311
Interventional - Phase 2 - Terminated
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.
Conditions
Pancreatic Carcinoma
Interventions
Botulinum Toxin Type A
Eligibility
Inclusion criteria
# 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
# 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
* Pregnancy or lactation
* Any condition that could result in undue risk for the participant and/or influence outcome measures (in the opinion of the investigator)