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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48251

Enrollment

Registered

2019-04-02

Start date

2019-09-11

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-operative pancreatic fistula

Interventions

Pre-operative endoscopic BOTOX® injection. The single BOTOX® injection will consist of 100 units of BOTOX® reconstituted in 1 mL of 0.9% NaCl will be injected into the sphincter of Oddi (in the one

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
As a secondary endpoint we will assess the effect of preoperative endoscopic BOTOX injection in the sphincter of Oddi on the occurrence of postoperative pancreatic fistulas.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)