Prevention of complications after endoscopic retrograde cholangio-pancreaticography using the antihypertensive drug Cozaar®
| ISRCTN | ISRCTN61320108 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61320108 |
| EudraCT/CTIS number | 2005-004545-34 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/11/2009
- Registration date
- 04/01/2010
- Last edited
- 19/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mats Lindblad
Scientific
Scientific
Upper Gastrointestinal Research Group (UGIR)
Karolinska Institutet
Norra Stationsgatan 67
Stockholm
171 76
Sweden
| Phone | +46 (0)8 517 711 43 |
|---|---|
| mats.lindblad@karolinska.se |
Study information
| Study design | Triple blinded randomised placebo-controlled multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Losartan (Cozaar®) |
| Primary outcome measure | Hyperenzymemia (amylase and or lipase) 24 hours after ERCP |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2006 |
| Completion date | 31/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Upper Gastrointestinal Research Group (UGIR)
Stockholm
171 76
Sweden
171 76
Sweden
Sponsor information
Karolinska Institutet (Sweden)
Research organisation
Research organisation
c/o Jesper Lagergren
Upper Gastrointestinal Research Group (UGIR)
Norra Stationsgatan 67
Stockholm
171 76
Sweden
| Phone | +46 (0)8 517 760 12 |
|---|---|
| jesper.lagergren@ki.se | |
| Website | http://ki.se/ki/jsp/polopoly.jsp?d=130&l=sv |
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
Research organisation
Swedish Society of Medicine (Sweden)
No information available
Lisa and Johan Grönberg Foundation (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 05/02/2021 | 19/05/2022 | No | No |
Editorial Notes
19/05/2022: EU Clinical Trials Register results added.
