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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

11 Nov 2019 → 13 Jan 2026

Decision date (initial)

2024-09-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-517267-23-00

EudraCT number

2018-004239-63

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

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

Secondary objectives 1

1. To examine the effect of preoperative endoscopic BOTOX® injection in the sphincter of Oddi on the occurrence of postoperative pancreatic fistulas.

Conditions and MedDRA coding

postoperative pancreatic fistulas

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 1

1. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 1

1. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

C.J. Pek

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

C.J. Pek

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications