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

Phase 1/2

Recruiting

• Conditions: postoperative pancreatic fistulas

• Registration Number: 2024-517267-23-00
• Lead Sponsor: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Brief Summary

To examine the feasibility and safety of preoperative endoscopic BOTOX® injection in the sphincter of Oddi.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:  Age ≥ 18 years.  Lesion(s) of the body and/or tail of the pancreas for which open, laparoscopic or robotassisted distal pancreatectomy will be performed.  Signed informed consent.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:  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: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.		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 Outcome Measures

Name	Time	Method
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.		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.

Trial Locations

Locations (1)

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC); 🇳🇱 Rotterdam, Netherlands

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

🇳🇱Rotterdam, Netherlands

C.H.J. van Eijck

Site contact

+31107033854

c.vaneijck@erasmusmc.nl