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Botulinum toxin (BOTOX®) to prevent post-operative pancreatic fistula in patients who undergo distal pancreatectomy
EU CTIS ID: 2024-517267-23-00
What this study is testing
To examine the feasibility and safety of preoperative endoscopic BOTOX® injection in the sphincter of Oddi.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- In order to be eligible to participate in this study, a subject must meet all of the following criteria: Age ≥ 18 years. Lesion(s) of the body and/or tail of the pancreas for which open, laparoscopic or robotassisted distal pancreatectomy will be performed. Signed informed consent.
You likely can't join if
- A potential subject who meets any of the following criteria will be excluded from participation in this study: Hypersensitivity to BOTOX® (or the components in the BOTOX® formulation). American Society of Anesthesiologists score >III. Unable to undergo duodenoscopy (due to any anatomic condition). Pregnancy or lactation. Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.