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

Phase 1

• Conditions: Post-operative pancreatic fistula; MedDRA version: 20.0Level: PTClassification code 10049192Term: Pancreatic fistulaSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-004239-63-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-02
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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.

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

•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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine the feasibility and safety of preoperative endoscopic BOTOX® injection in the sphincter of Oddi.<br><br>;Secondary Objective: To examine the effect of preoperative endoscopic BOTOX® injection in the sphincter of Oddi on the occurrence of postoperative pancreatic fistulas.<br>;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 Outcome Measures

Name	Time	Method
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