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NCT04965311 · ClinicalTrials.gov registry record · Phase 2
Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy
A Phase 2 study, sponsored by OHSU Knight Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT04965311 is a Phase 2 study that was terminated before completion, run by OHSU Knight Cancer Institute. The registered enrollment target is 4 participants.
The verdict
NCT04965311, a Phase 2 study, was terminated before completion, sponsored by OHSU Knight Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Botulinum Toxin Type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2024-07-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04965311
The ClinicalTrials.gov registry entry for NCT04965311 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OHSU Knight Cancer Institute, which has 211 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Botulinum Toxin Type A is the first listed.
NCT04965311 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04965311 about?
NCT04965311 is a clinical study titled "Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy". 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 swellin...
What is the current status of trial NCT04965311?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2023-03-01. Estimated completion is 2024-07-10.
What interventions are being tested in trial NCT04965311?
The interventions under investigation include: Botulinum Toxin Type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT04965311?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
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