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

ISRCTN	ISRCTN61320108
DOI	https://doi.org/10.1186/ISRCTN61320108
Clinical Trials Information System (CTIS)	2005-004545-34
Protocol serial number	N/A
Sponsor	Karolinska Institutet (Sweden)
Funders	Swedish Society of Medicine (Sweden), Lisa and Johan Grönberg Foundation (Sweden)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Mats Lindblad
Scientific

Upper Gastrointestinal Research Group (UGIR)
Karolinska Institutet
Norra Stationsgatan 67
Stockholm
171 76
Sweden

Phone	+46 (0)8 517 711 43
Email	mats.lindblad@karolinska.se

Primary study design	Interventional
Study design	Triple blinded randomised placebo-controlled multicentre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial of the angiotensin II receptor blocker losartan (Cozaar®) in the prevention of hyperenzymemia after endoscopic retrograde cholangio-pancreaticography (ERCP)
Study objectives	Angiotensin II receptor type 1 blocker prevents post-endoscopic retrograde cholangio-pancreaticography (ERCP) pancreatitis.
Ethics approval(s)	Regional Ethical Committee in Stockholm approved on the 12th January 2005 (ref: 2005/1278-31/2)
Health condition(s) or problem(s) studied	Post-endoscopic retrograde cholangio-pancreaticography pancreatitis
Intervention	Patients are randomised to placebo or 50 mg losartan (Cozaar®) given orally one hour before ERCP. The interventions are given once only; planned follow up is 24 hours.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Losartan (Cozaar®)
Primary outcome measure(s)	Hyperenzymemia (amylase and or lipase) 24 hours after ERCP
Key secondary outcome measure(s)	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 2. Pain measured by the visual analogue scale (VAS) (0 = no pain, 10 = unbearable pain) pre-ERCP and 24 hours after ERCP
Completion date	31/10/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Patients above 18 years of age, either sex 2. ERCP indicated for diagnostic or therapeutic reasons 3. Informed consent
Key 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)
Date of first enrolment	01/04/2006
Date of final enrolment	31/10/2008

Upper Gastrointestinal Research Group (UGIR)

Stockholm
171 76
Sweden

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		05/02/2021	19/05/2022	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

19/05/2022: EU Clinical Trials Register results added.