Botulinum toxin (BOTOX®) to prevent post-operative pancreatic fistula in patients who undergo distal pancreatectomy. (PROFIT study)
- Conditions
- Pancreatic cancer
- Registration Number
- NL-OMON22900
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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 To examine the feasibility and safety of preoperative endoscopic BOTOX® injection in the sphincter of Oddi.
- Secondary Outcome Measures
Name Time Method To examine the effect of preoperative endoscopic BOTOX® injection in the sphincter of Oddi on the occurrence of postoperative pancreatic fistulas.