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.

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.

Screening
Endoscopic BOTOX injection
Pancreatic surgery
2 weeks post surgery
4 weeks post surgery

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