Fluid hydration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis: the FLUYT-prevent trial. a multicenter randomized controlled superiority trial.;Pancreatic duct stent placement to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in patients with unintended PD-wire cannulation: a multicenter prospective cohort - FLUYT-prevent trial FLUYT -2-PDS

Sint Antonius Ziekenhuis0 个研究点目标入组 1,108 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1) Allergy to NSAID*s or other contraindications 2) Ongoing acute pancreatitis
•3) Ongoing hypotension, including those with sepsis 4) Cardiac insufficiency
•(>NYHA Class I heart failure) 5) Renal insufficiency (RI, GFR <30ml/min) 6)
•Active ulcer disease 7) Severe liver dysfunction: Liver cirrhosis and currently
•ascites 8) Respiratory insufficiency (pO2<60mmHg or 90% despite FiO2 of 30% or
•requiring mechanical ventilation). 9) Pregnancy 10) Hyponatremia (Na+ levels <
•130mmol/l) 11) Hypernatremia (Na+ levels > 150mmol/l) 12) Oedema 13) Low risk
•of PEP: chronic calcific pancreatitis (according to M-ANNHEIM criteria) with a
•CBD intervention (PD intervention is allowed --> not in FLUYT-2-PDS); or
•pancreatic head mass; or routine biliary stent exchange; or re-ERCP with a
•history of endoscopic sphincterotomy with a CBD intervention (PD intervention
•is allowed --> not in FLUYT-2-PDS) 14) Planned prophylactic pancreatic stent
•placement 15) Altered anatomy, defined as anatomical variations in which gall
•and/or pancreatic juices (in case of pancreatic duct interventions) do not
•enter the duodenum by way of the ampulla of Vater. This is the case after
•surgical interventions such as Roux-Y reconstruction, surgery for chronic
•pancreatitis, gastric bypass or surgical ampullectomy. 16) Patients receiving
•more than 1.5ml/kg/hr of intravenous fluids before ERCP

发起方