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

Despite advances in surgical techniques, the occurrence of postoperative
pancreatic fistula (POPF) is still a major cause of potentially severe and
costly morbidity after distal pancreatectomy. Good quality evidence on how to
prevent POPF is lacking. Existing interventions such as somatostatin analogues,
varying surgical closure techniques, pre-operative duct stenting or
percutaneous drains, do not work well or have too many complications/side
effects. Pre-operative peri-ampullary injection of BOTOX® might reduce the
incidence of POPF by decreasing intra-ductal pressure via relaxation of the
sphincter of Oddi.

In this study we will first analyze the safety and feasibility of peri-ampullar
endoscopic BOTOX® injections in a small group of patients (n=15). If the
procedure is safe and feasible we will continue this study in an additional 35
patients to investigate whether this procedure indeed reduces the POPF rate.

This study has been transitioned to CTIS with ID 2024-517267-23-00 check the CTIS register for the current data.

The aim of this research is to investigate whether it is feasible and safe to
pre-operatively treat patients who will undergo a distal pancreatectomy with
endoscopic BOTOX® injections and if this procedure will reduce POPFS.

Single center open label phase I/II pilot study.

Pre-operative endoscopic BOTOX® injection. The single BOTOX® injection will
consist of 100 units of BOTOX® reconstituted in 1 mL of 0.9% NaCl will be
injected into the sphincter of Oddi (in the one o*clock position).

The endoscopic procedure has a small chance of suffocation, gastrointestinal
bleeding and gastrointestinal perforation.

The BOTOX® injection itself may lead to side effects such as local pain and
tenderness, local inflammation / infection of the injection site, itching /
tingling, reduced touch sensation, swelling / edema, redness of the skin,
bleeding and / or bruising of the injection site.

Both the execution of endoscopic procedures and the administration of BOTOX®
injections are standard procedures within our hospital. However, the
combination of both is not standard. Since both interventions have a very low
chance of complication, it is expected that combining both interventions will
not lead to a higher chance of complications. We consider the possibility of
complications to be justified in view of the potential benefit that patients
may experience from the proposed treatment.