Clinical trial · Interventional
Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy
A Phase II Trial of Pre-Operative Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low enrollment
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Carcinoma | Pancreatic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Botulinum Toxin Type A | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment of POPF (botulinum toxin type A)
- description
- 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.
- interventionNames
- Biological: Botulinum Toxin Type A
Primary outcomes (1)
- measure
- Number of Participants With Clinically Relevant Postoperative Pancreatic Fistula (POPF)
- timeFrame
- Up to postoperative day 30
- description
- Defined by standard biochemical definitions of POPF per the International Study Group of Pancreatic Fistula (ISGPF) criteria.
Secondary outcomes (2)
- measure
- Rate of Serious Adverse Event
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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)
References
Publications (0)
Data not yet available