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Neurotoxin
Botox Injection for Preventing Pancreatic Fistula After Surgery
Phase 2
Recruiting
Led By Brett C Sheppard, M.D., FACS
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant >= 18 years of age
Ability to understand nature and individual consequences of clinical trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to postoperative day 30
Awards & highlights
Study Summary
This trial will study whether giving Botox to patients before surgery can prevent POPF.
Who is the study for?
Adults scheduled for elective distal pancreatectomy or RAMPS who can understand the trial and consent to it. They must not be pregnant, have a negative pregnancy test, and use contraception until 14 days post-intervention. Exclusions include hypersensitivity to Botox, infection at injection site, recent acute pancreatitis, severe anesthesia risk (ASA score > III), liver cirrhosis, comprehension barriers, non-compliance risks, neuromuscular diseases increasing BTX risks.Check my eligibility
What is being tested?
The trial is testing if injecting Botulinum Toxin Type A (Botox) into the Sphincter of Oddi before surgery can prevent pancreatic fistula by reducing digestive fluid leakage after a distal pancreatectomy. It's a phase II study aiming to see how effective this intervention is in preventing complications.See study design
What are the potential side effects?
Possible side effects of Botox may include muscle paralysis around the injection area leading to changes in digestion flow control. There might also be typical injection-related reactions such as pain or swelling at the site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I understand what joining this clinical trial means for me.
Select...
I am scheduled for surgery on the tail of my pancreas or pancreas and spleen removal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to postoperative day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to postoperative day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of clinically relevant postoperative pancreatic fistula (POPF)
Secondary outcome measures
Rate of any POPF
Rate of serious adverse event
Side effects data
From 2010 Phase 4 trial • 50 Patients • NCT010040424%
Edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non Depressed Subjects
Depressed Subjects
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment of POPF (botulinum toxin type A)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum Toxin Type A
2014
Completed Phase 4
~4520
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,663 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
974 Previous Clinical Trials
7,385,849 Total Patients Enrolled
Brett C Sheppard, M.D., FACSPrincipal InvestigatorOHSU Knight Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously received Botox treatments.Your kidneys are not working well enough, based on a test called creatinine clearance.I do not have an infection where I will get the injection.I have liver cirrhosis.I am 18 years old or older.I understand what joining this clinical trial means for me.I am scheduled for surgery on the tail of my pancreas or pancreas and spleen removal.You have a health condition that is very serious according to the American Society of Anesthesiologists.You are allergic to any BTX product or any of the ingredients in it.I have not had acute pancreatitis in the last 2 weeks.I have a neurological condition that could make BTX injections risky for me.My body's structure doesn't allow for the planned surgery.I do not have serious heart conditions like recent heart attacks or severe heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment of POPF (botulinum toxin type A)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions are typically addressed using Botulinum Toxin Type A?
"Botulinum Toxin Type A is an effective therapy for managing symptoms of urinary incontinence, spinal cord issues, and wrinkles caused by facial expressions."
Answered by AI
What is the present pool of participants in this research project?
"Affirmative. Clinicaltrials.gov information affirms that the trial, which commenced on September 26th 2022, is actively seeking participants. Approximately 63 subjects are needed from one medical site."
Answered by AI
What safety measures have been taken to ensure the utilization of Botulinum Toxin Type A does not cause harm?
"Botulinum Toxin Type A is assigned a rating of 2, as there is limited clinical data available to support its safety. No efficacy-related information has been found in the course of this Phase 2 trial."
Answered by AI
Is this experiment actively seeking participants at the present moment?
"Evidenced by clinicaltrials.gov, this medical trial is still in the process of finding participants. It was originally uploaded on September 26th 2022 and subsequently revised November 21st 2022."
Answered by AI
What other explorations have been conducted that involve Botulinum Toxin Type A?
"Currently, there are 61 clinical trials in process for Botulinum Toxin Type A with 20 studies reaching the Phase 3 testing phase. The majority of these trial sites can be found in Farmington Hills, Michigan; however, across the United States there are 754 centers offering research opportunities related to this agent."
Answered by AI
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