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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54543

Enrollment

1108

Registered

2015-04-14

Start date

2015-06-05

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-ERCP pancreatitis

Interventions

FLUYT: Patients in the intervention group will receive 20cc/kg Ringer's lactate within 60 minutes at the start of ERCP (scope-mouth contact), followed by 3cc/kg/hour during 8 hours post ERCP AND rec

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18 to 85 written informed consent

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
FLUYT+ FLUYT-2-PDS: post-ERCP pancreatitis	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)