Intrapapillary Botulinum Toxin Injection for PREvention of Post-surgical PAncREactic Fistula
Status:
Not yet recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
Surgery is required for the treatment of many pancreatic conditions, either malignant or
benign. Mortality of pancreatic surgery can be up to 3% even in expert centers. Morbidity is
high, postoperative pancreatic fistula (POPF) being the main postoperative complication. In
its current definition (drain output of any measurable fluid >= postoperative day 3 with
amylase content >3 times the serum amylase activity and with clinical consequence), the
incidence of postoperative PF is between 15 and 30 %. Most POPF resolve spontaneously but
when refractory POPF occurs, it may lead to severe complications. POPF severity is graded as
follows: grade B in case of change in medical management: infection without organ failure,
specific medication (total parenteral nutrition, somatostatin analogs, antibiotics),
persistent drainage > 3 weeks, angiographic procedure for bleeding, prolonged hospital stay;
grade C in case of reoperation or PF-related organ failure or death.
No specific prophylactic treatment of POPF is currently recommended by clinical guidelines.
In clinical research, many prophylactic strategies have been attempted with partial efficacy.
Endoscopic pancreatic sphincterotomy with plastic stent placement is effective in pre-and
postoperative management of pancreatic fistula but with the need of a highly competent
interventional endoscopist. Intrapapillary botulinum toxin injection is believed to induce
relaxation of the pancreatic sphincter, leading to a " pharmacological " pancreatic
sphincterotomy without any morbidity.
A recent phase I/II prospective study has shown promising results in this indication, with no
clinically relevant pancreatic fistula when botulinum toxin was injected. Based on this
observation we hypothesize that intrapapillary botulinum toxin injection during an endoscopic
procedure before surgery could be effective for the prevention of post-surgical pancreatic
fistula