Can Angiotensin II type 1 Receptor Inhibitor Be Used to Lower the Amount of Lipase and Amylase Level after Endoscopic Retrograde Cholangio-Pancreatography? - AT1-antagonist and post-ERCP-complications
- Conditions
- The clinical diagnosis of acute pancreatitis is set by a combination of symptoms (abdominal pain) and increased blood levels of pancreatic enzymes (i.e. amylase and lipase). The most common complication of Endoscopic Retrograde Cholangio-Pancreatography (ERCP) is acute pancreatitis (7%, Freeman et al 1996). Increased blood levels of amylase and lipase is seen in 25-40% of cases after ERCP (Tsujino et al 2005).
- Registration Number
- EUCTR2005-004545-34-SE
- Lead Sponsor
- nit of Esophageal and Gastric Research Dep. of Molecular Medicine and Surgery Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 400
Informed consent from patients planned for ERCP.
Over 18 years of age.
No ERCP during the last year
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Under 18 years of age
Pregnant or nursing women
Patient not able to informed consent
Patient taking AT1- or ACE-inhibitor
Patient with current acute pancreatitis
Patient with clinical acute pancreatitis
DIC, severe sepsis or shock
Dehydration, hypovolemia or hypotension (<100-110 mm Hg systolic Blood Pressure
Known hypersensitivity or allergia to Cozaar
Severe liver cirhosis
Severe renal insuffiency (Crea <10 ml/min) or in dialysis
Bilateral renal artery stenosis or single renal stenosis in case of single-kidney patient
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To elucidate wether prophylactic treatment with Cozaar can reduce enzyme level of lipase and amylase after ERCP;Secondary Objective: To evaluate the efficacy of Cozaar on reducing incidence of acute pancreatitis after ERCP;Primary end point(s): Measurement of lipase / amylase level at baseline, 4h and 18 h respectively after the procedure.<br>Analysis of pain 24 h after procedure. <br><br>Blood glucose level 4 h after procedure. <br>Blood pressure monitoring until 6 h after intake of Cozaar.<br>
- Secondary Outcome Measures
Name Time Method