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Intrapapillary Botulinum Toxin Injection for PREvention of Post-surgical PAncREactic Fistula

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with scheduled distal pancreatectomy for any indication: open or laparoscopic distal pancreatectomy with or without splenectomy * Age ≥ 18years Exclusion Criteria: * History of myasthenia gravis or Eaton-Lambert syndrome * Inflammatory myositis \<2 years or preexisting motor neuron disease or neuropathies * ASA score \> III * Pregnancy or lactation * Altered anatomy of the duodenum and/or the major papilla (prior surgery, prior endoscopic sphincterotomy) * Scheduled pancreaticoduodenectomy (Whipple procedure) * Scheduled total pancreatectomy * Scheduled central pancreatectomy * Scheduled pancreatic enucleation * Calcified chronic pancreatitis (suspected on preoperative cross-sectional imaging) * Pancreas divisum (suspected on preoperative cross-sectional imaging) * Toxin botulinum contraindications (hypersensitivity to albumin or to saccharose, infection or inflammation at the injection site concerned, generalized muscle weakness) * Preoperative administration of somatostatin analogs: for long-acting somatostatin analogs, a 1-month washout period is necessary; for short-acting somatostatin analogs, a 24-hours washout period is necessary * Any kind of surgical method to reinforce the pancreatic stump: * Use of a bioabsorbable patch * Use of fibrin glue * Use of a ligament patch * Tutorship, trusteeship * Concurrent participation in other experimental trials * Not Affiliation to the French social security * Not Ability to give their consent and not written informed consent * Distal pancreatectomy extended to neighbouring organs (except spleen and gallbladder) or to the vessels (celiac axis, portal vein) Secondary exclusion criteria: patients who did not have the planned surgery in less than 4 weeks after the botulinum toxin injection.
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What it tests

  • botulinum toxin injection
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Where

1 site
PRAT
Clichy, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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