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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517267-23-00

Acronym

NL68231.078.18

Enrollment

Registered

2024-09-25

Start date

2019-11-11

Completion date

Unknown

Last updated

2024-09-25

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

Conditions

postoperative pancreatic fistulas

Brief summary

The primary endpoint of this pilot project is to determine the feasibility and safety of 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.

Detailed description

As a secondary endpoint we will investigate the effect of preoperative endoscopic BOTOX® injection in the sphincter of Oddi on the occurrence of postoperative pancreatic fistulas.

Interventions

DRUGBOTOX 100 Allergan Units Powder for Solution for Injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this pilot project is to determine the feasibility and safety of 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.	—

Secondary

Measure	Time frame
As a secondary endpoint we will investigate 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: EU CTIS · Data processed: Feb 4, 2026