Magnesiumsulfate in the prevention of post-ERCP pancreatitis – a prospective randomized, placebocontrolled multicenter study

Conditions: Post-ERCP pancreatitis
MedDRA version: 17.0Level: PTClassification code 10033645Term: PancreatitisSystem Organ Class: 10017947 - Gastrointestinal disorders

Registration Number: EUCTR2009-013294-18-HU

Lead Sponsor: niversity of Szeged, First Department of Internal Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 802

Inclusion Criteria

Adult (= 18 years of age) patients (male and female) with a medical indication for a diagnostic or therapeutic
endoscopic retrograde cholangiopancreatography (ERCP).
Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known allergy or intolerance to one of the medicaments utilized in the study or their ingredients

Participation in another clinical study during the previous four weeks

Pregnancy and breast feeding

Acute pancreatitis

Renal insufficiency = stadium 4 (K/DOQI)

Hyperthyreoidism

Symptomatic Bradycardia <35 bpm

Atrioventricular block > 1° or other cardial conduction defects

Myasthenia gravis

Liver cirrhosis Child C

Any apparent coagulopathy

Kidney stone diathesis (calcium-magnesium-ammonium-phosphate stones)

Mental impairment, addicitve or other disorders leading to the patients inability to understand the scope and
possible consequences of a participation in the clinical trial

Magnesium medication within 14 days before the procedure

Inability to give informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 50% reduction of the incidence of post-ERCP pancreatitis as defined in the study protocol;Secondary Objective: reduction of analgesics use<br>reduction of length of hospital stay<br>reduction of procedure-related morbidity<br>;Primary end point(s): Reduction of the incidence of post-ERCP pancreatitis by 50%

Secondary Outcome Measures