Peri-procedural intensive RL hydration on top of RN will reduce the incidence of PEP in a moderate-high risk population, and may even reduce the percentage of severe PEP. This may improve patients’ health status, prevent serious complications of…
ID
Bron
Verkorte titel
Aandoening
ERCP, pancreatitis, lactated Ringers solution, prevention
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Post-ERCP pancreatitis (Cotton criteria)
Doel van het onderzoek
Peri-procedural intensive RL hydration on top of RN will reduce the incidence of PEP in a moderate-high risk population, and may even reduce the percentage of severe PEP. This may improve patients’ health status,
prevent serious complications of PEP, reduce the demand for healthcare, and will lower costs. We hypothesize that this peri-procedural intensive RL hydration therapy is superior to usual care with respect to patient outcomes (PEP).
Onderzoeksopzet
1) Patient-related quality of life: at 30, 90 and 180 days
2) Exocrin and endocrin pancreatic insufficiency at 180 days
Onderzoeksproduct en/of interventie
Intervention: Ringer's lactated solution
Control: NaCl 0.9%
Publiek
Xavier Smeets
Postbus 2500
Nieuwegein 3430 EM
The Netherlands
088-320 7054
x.smeets@pancreatitis.nl
Wetenschappelijk
Xavier Smeets
Postbus 2500
Nieuwegein 3430 EM
The Netherlands
088-320 7054
x.smeets@pancreatitis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1) Age 18-85
2) Indication for ERCP
3) Written Informed Consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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<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 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
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5020 |
| NTR-old | NTR5166 |
| Ander register | ABR NL52341.100.15 : ISRCTN13659155 |