Botulinum toxin (BOTOX®) to prevent post-operative pancreatic fistula in patients who undergo distal pancreatectomy. (PROFIT study)

Phase 2

Recruiting

• Conditions: 10015674; post-operative pancreatic fistula; 10017991

• Registration Number: NL-OMON48251
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

• Age >= 18 years.
• Lesion(s) of the body and/or tail of the pancreas for which open,
laparoscopic or robot-assisted distal pancreatectomy will be performed.
• Signed informed consent.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this project is to determine the feasibility and safety<br /><br>of a preoperative endoscopic BOTOX injection in the sphincter of Oddi. We deem<br /><br>this treatment feasible in case we can complete the proposed treatment in 14<br /><br>out of 15 patients without any procedure related complications.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>As a secondary endpoint we will assess the effect of preoperative endoscopic<br /><br>BOTOX injection in the sphincter of Oddi on the occurrence of postoperative<br /><br>pancreatic fistulas.</p><br>