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2023-03-01
2024-07-10
2024-07-10
4
NCT04965311
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
INTERVENTIONAL
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 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.
PRIMARY OBJECTIVE: I. Evaluate the efficacy of pre-operative botulinum toxin type A (BTX) injection compared to no therapy for the prevention of clinically relevant POPF. SECONDARY OBJECTIVES: I. Evaluate the safety of pre-operative BTX injection into the Sphincter of Oddi. II. Evaluate the efficacy of pre-operative BTX injection compared to no therapy for the prevention of all POPF. EXPLORATORY OBJECTIVES: I. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in POPF. II. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in clinically relevant POPF (crPOPF). III. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in postoperative length of hospital stay. IV. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of Clavien-Dindo grade III or greater complications. V. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of percutaneous drainage. VI. Using a historical population matched for potential confounding clinicopathologic variables, evaluate differences in rate of unplanned re-operation. OUTLINE: 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. Patients are followed for 30 days following distal pancreas resection.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-07-07 | 2025-02-04 | 2025-05-09 |
2021-07-07 | 2025-05-09 | 2025-05-13 |
2021-07-16 | 2025-05-13 | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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. | BIOLOGICAL: Botulinum Toxin Type A
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Relevant Postoperative Pancreatic Fistula (POPF) | Defined by standard biochemical definitions of POPF per the International Study Group of Pancreatic Fistula (ISGPF) criteria. | Up to postoperative day 30 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Rate of Serious Adverse Event | Using the safety analysis set, the rate of serious adverse events following endoscopic BTX injection into the sphincter of Oddi as a single agent will be determined for participants undergoing distal pancreas resections. The 95% confidence interval will be reported with the point estimate of serious adverse events (SAE) rate. | Prior to surgery up to 30 days post surgery (up to 3 months) |
| Number of Participants With Any POPF | Prior to surgery up to 30 days post surgery (up to 3 months) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
