Prevention of complications after endoscopic retrograde cholangio-pancreaticography using the antihypertensive drug Cozaar®

Not Applicable

Completed

• Conditions: Acute pancreatitis; Post-endoscopic retrograde cholangio-pancreaticography pancreatitis; Digestive System

• Registration Number: ISRCTN61320108
• Lead Sponsor: Karolinska Institutet (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-10-31
• Study Start: 2010-01-04
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients above 18 years of age, either sex
2. ERCP indicated for diagnostic or therapeutic reasons
3. Informed consent

Exclusion Criteria

1. Previous ERCP within one year
2. Current elevation of pancreatic amylase and lipase
3. Ongoing acute or chronic pancreatitis
4. Current use of any angiotensin I converting enzyme (ACE) inhibitor or angiotensin II type 1 receptor blocker
5. Bilateral renal artery stenosis or unilateral in case of a single kidney
6. Known hypersensitivity to angiotensin II type 1 receptor blockers
7. Pregnancy
8. Breastfeeding
9. Predefined severe disease (e.g. ongoing sepsis, disseminated intravascular coagulopathy, acute circulatory collapse, severe dehydration, hypovolaemia, severe renal insufficiency or severe liver failure)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hyperenzymemia (amylase and or lipase) 24 hours after ERCP

Secondary Outcome Measures

Name	Time	Method
<br> 1. Pancreatitis after ERCP defined as abdominal pain persisting more than 24 hours after ERCP and hyperenzymemia defined as three times the upper normal limit<br> 2. Pain measured by the visual analogue scale (VAS) (0 = no pain, 10 = unbearable pain) pre-ERCP and 24 hours after ERCP<br>