BOTOX® to prevent post-operative pancreatic fistals after pancreatic surgery. PROFITstudy.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004239-63-NL

Enrollment

Registered

2019-04-02

Start date

2019-08-23

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Post-operative pancreatic fistula MedDRA version: 20.0 Level: PT Classification code 10049192 Term: Pancreatic fistula System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: BOTOX® (Allergan) Product Name: BOTOX® (Allergan) Product Code: RVG 117147 Pharmaceutical Form: Powder for solution for injection

Eligibility

Sex/Gender

All

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

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
Main Objective: To examine the feasibility and safety of preoperative endoscopic BOTOX® injection in the sphincter of Oddi. ;Secondary Objective: To examine the effect of preoperative endoscopic BOTOX® injection in the sphincter of Oddi on the occurrence of postoperative pancreatic fistulas. ;Primary end point(s): 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 12 out of 15 patients.;Timepoint(s) of evaluation of this end point: LPLV	—

Measure

Time frame

Main Objective: To examine the feasibility and safety of preoperative endoscopic BOTOX® injection in the sphincter of Oddi. ;Secondary Objective: To examine the effect of preoperative endoscopic BOTOX® injection in the sphincter of Oddi on the occurrence of postoperative pancreatic fistulas. ;Primary end point(s): 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 12 out of 15 patients.;Timepoint(s) of evaluation of this end point: LPLV

—

Secondary

Measure	Time frame
Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: LPLV	—

Countries

Netherlands

Contacts

Public Contactproject manager

Erasmus MC

j.verhagen-oldenampsen@erasmusmc.nl0031650032401

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026