Post-ERCP Pancreatitis
Conditions
Keywords
MagPEP, post-ERCP pancreatitis, Magnesium Sulfate
Brief summary
MagPEP is a multi-centre, randomized, phase III, double blind, placebo controlled, parallel group trial. It evaluates magnesium sulfate for the prevention of post-ERCP pancreatitis. Adult patients with a medical indication for ERCP are to be randomized (1:1 ratio) to receive either magnesium sulfate or placebo (NaCl 0,9%) 60 min before and 6 hours after ERCP.
Detailed description
Title: prospective, randomized, placebo controlled, phase III trial to evaluate the efficacy of magnesium sulfate for the prevention of post-ERCP pancreatitis Study drug: Magnesium sulfate Indication: post-ERCP pancreatitis Study design: multi-centre, randomized, phase III, double blind, placebo controlled, parallel group Patient population: adult patients with a medical indication for ERCP Number of patients: 1376 randomized to two equal groups Treatment: patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP and the second one 6 hours after ERCP. To the infusions 10 ml of either magnesium sulfate or placebo (NaCl 0,9%) will be added.
Interventions
DRUGMagnesium Sulfate
Patients receive 2 infusions (10 ml magnesium sulfate added to 500 ml NaCl 0.9%): the first infusion 60 min before and the second one 6 hours after ERCP
Patients receive 2 infusions (10 ml NaCl 0.9% added to 500 ml NaCl 0.9%): the first infusion 60 min before and the second one 6 hours after ERCP
Sponsors
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* medical indication for ERCP * first ERCP in the Patient * signed informed consent forms for ERCP and MagPEP trial
Exclusion criteria
* privious ERCP * hypersensitivity to study medication or similar substances * participation in another clinical trial during the last 4 weeks * addictive disorders * women who are pregnant or breastfeeding * unwillingness or inability to comply with study protocol * acute pancreatitis * renal insufficiency of stage 4 or higher * active hyperthyreosis * symptomatic bradycardia (\<35/min) * known history of Myasthenia gravis * AV bock \> first degree or other bradycardic disorders of conductivity * liver cirrhosis Child C * coagulation disorder * urinary stone diathesis (calcium magnesium ammonium phosphate stones) * patients who are not able to provide informed consent * intake of magnesium during the last 14 days * intake of calcium antagonists
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction in the incidence of post-ERCP pancreatitis by 50 % | 24 hours after ERCP |
Secondary
| Measure | Time frame |
|---|---|
| reduction in intake of analgesics | during the first 24 hours after ERCP and, if a post-ERCP pancreatitis occurs, until discharge from hospital |
| duration of stay in hospital after ERCP | from end of ERCP to discharge from hospital; assessed on day 30 after ERCP |
| reduction in premature protease activation | during treatment period, assessed 24 h after ERCP |
| reduction in severity of post-ERCP pancreatitis | from 24 hours after ERCP onwards, assessed on day 30 after ERCP |
| reduction in 30-day morbidity | 30 days after ERCP |
Countries
Germany
Outcome results
None listed