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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1108

Inclusion Criteria

Age 18 to 85
written informed consent

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>FLUYT+ FLUYT-2-PDS: post-ERCP pancreatitis</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>FLUYT+ FLUYT-2-PDS:<br /><br>-severity of post-ERCP pancreatitis<br /><br>-morbidity<br /><br>-mortality<br /><br>-ERCP related complications (bleeding, perforation, cholangitis)<br /><br>-oedema<br /><br>-hyperhydration (pulmonary)<br /><br>-total length of stay<br /><br>-Quality of life<br /><br>-cost effectiveness and utility<br /><br>-pancreatic insufficiency<br /><br><br /><br>Additionally in FLUYT-2-PDS:<br /><br>PDS placement failure<br /><br>gastroscopy needed to remove the PDS<br /><br>How often does a patient develop PEP after PDS removal</p><br>