No registrations found.
ID
Source
Brief title
Health condition
ERCP, pancreatitis, lactated Ringers solution, prevention
Sponsors and support
Intervention
Outcome measures
Primary outcome
Post-ERCP pancreatitis (Cotton criteria)
Secondary outcome
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 <200 ìg/L, HbA1c >42 mmol/mol.
10) Incidence of delayed PEP (PEP >48h after the procedure).
Study objective
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).
Study design
1) Patient-related quality of life: at 30, 90 and 180 days
2) Exocrin and endocrin pancreatic insufficiency at 180 days
Intervention
Intervention: Ringer's lactated solution
Control: NaCl 0.9%
Xavier Smeets
Postbus 2500
Nieuwegein 3430 EM
The Netherlands
088-320 7054
x.smeets@pancreatitis.nl
Xavier Smeets
Postbus 2500
Nieuwegein 3430 EM
The Netherlands
088-320 7054
x.smeets@pancreatitis.nl
Inclusion criteria
1) Age 18-85
2) Indication for ERCP
3) 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, 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5020 |
| NTR-old | NTR5166 |
| Other | ABR NL52341.100.15 : ISRCTN13659155 |