Does prophylactic administration of magnesium reduce the risk and severity of post-endoscopic retrograde cholangiopancreatography (post-ERCP) pancreatitis? A clinical study.

Completed

Conditions: Post-ERCP pancreatitis
Digestive System
Acute pancreatitis

Registration Number: ISRCTN46556454

Lead Sponsor: niversity Hospital Greifswald (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 502

Inclusion Criteria

1. Adult (greater than or equal to 18 years of age) patients (male and female) with a medical indication for a diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP)
2. Written informed consent

Exclusion Criteria

1. Known allergy or intolerance to one of the medicaments utilised in the study or their ingredients
2. Participation in another clinical study during the previous four weeks
3. Pregnancy or breast feeding
4. Acute pancreatitis
5. Renal insufficiency greater than or equal to stadium 4 (National Kidney Foundation Disease Outcomes Quality Initiative™ [NKF KDOQI™])
6. Hyperthyroidism
7. Symptomatic bradycardia less than 35 bpm
8. Atrioventricular block greater than 1° or other cardial conduction defects
9. Myasthenia gravis
10. Liver cirrhosis Child C
11. Any apparent coagulopathy
12. Kidney stone diathesis (calcium-magnesium-ammonium-phosphate stones)
13. Mental impairment, addictive or other disorders leading to the patients inability to understand the scope and possible consequences of a participation in the clinical trial
14. Magnesium medication within 14 days before the procedure
15. Inability to give informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of the incidence of post-ERCP pancreatitis by 50%

Secondary Outcome Measures

Name	Time	Method
1. Intake of analgesics<br>2. Duration of hospital stay in days<br>3. Lipase levels measured 6 and 24 hours after ERCP<br>4. 30-days mortality as measured with the EQ-5D-questionnaire in the telephone interview 30 days after ERCP