Condition: Distal Pancreatectomy · Postoperative Pancreatic Fistula · Sponsor: Assistance Publique - Hôpitaux de Paris
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…
This description comes directly from the study's public registry record.
Frederic Prat, Prof · 0033(1)40875663 · frederic.prat@aphp.fr
Alain Sauvanet, Prof · alain.sauvanet@aphp.fr
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| PRAT | Clichy, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04220931