ERCP, pancreatitis, lactated Ringers solution, prevention
Conditions
Interventions
Intervention: Ringer's lactated solution
Control: NaCl 0.9%
Sponsors
Radboudumc
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age 18-85 2) Indication for ERCP 3) 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, creatinin clearance 40ml/min) 6) Active ulcer disease 7) Severe liver dysfunction: Liver cirrhosis and ascites 8) Respiratory insufficiency (pO2 150mmol/l) 12) Oedema 13) Low risk of PEP: chronic calcific pancreatitis or pancreatic head mass or routine biliary stent exchange; reERCP with a history of endoscopic sphincterotomy with a CBD intervention (PD intervention is allowed) 14) Planned prophylactic pancreatic stent placement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-ERCP pancreatitis (Cotton criteria) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Severity of PEP (according to the Cotton classification) 2) Severe morbidity (according to the revised Atlanta criteria) and mortality. 3) ERCP-procedure related complications: bleeding, perforation, post-ERCP fever/ cholangitis/ cholecystitis 4) Ringer's lactated solution hydration related complications, especially: pulmonary edema, cardiac insufficiency, peripheral edema,hypernatremia and renal failure. All adverse events will be monitored, according to good clinical practice (GCP). 5) Length of hospital and intensive care unit (ICU) stay. 6) Direct (non)medical costs, indirect costs, among others by using iMTA PCQ questionnaire 7) Generic health related quality of life measured with the EQ5D and the SF36 8) Risk-factors for PEP development: pre-ERCP BUN levels, validation of already known risk factors, BMI, smoking behavior, co-morbidity (diabetes, cardiovascular disease, ect.), sedation type (midazolam, propofol, fentanyl), social/ economic status, race. 9) Exocrine and endocrine pancreatic insufficiency at 180 days in patients who had developed PEP: fecal elastase-1 42 mmol/mol. 10) Incidence of delayed PEP (PEP >48h after the procedure). | — |
Contacts
Public ContactXavier Smeets
Datacenter Pancreatitis Werkgroep Nederland - Huispost PWN
Outcome results
None listed