ERCP- Antibiotics study
- Conditions
- Post-ERCP pancreatitis
- Registration Number
- NL-OMON22878
- Lead Sponsor
- ot applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
Patients undergoing an elective ERCP at the Elisabeth-TweeSteden hospital in Tilburg, who are willing to participate and give informed consent;
- Have the minimum age of 18 years or older.
- Patients who experience a chronic or acute pancreatitis;
- Patients with known pancreas malignancy;
- Patients treated with antibiotics/cholangitis;
- Patients with any contraindication or with a known allergy to ceftazidime or to any other cephalosporin antibiotics;
- History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins);
- Patients who are pregnant, lactating or planning pregnancy while enrolled in the study;
- Patients who are unsuitable for inclusion in the study in the opinion of the investigator for any reason that may compromise the subject's safety or confound data interpretation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of post-ERCP pancreatitis. Post-ERCP pancreatitis being defined as the presence of abdominal pain and an increased lipase.
- Secondary Outcome Measures
Name Time Method Incidence of delayed post-ERCP pancreatitis until four weeks after the procedure. Assessment which subgroup of patients are at risk of developing a Post-ERCP pancreatitis or which subgroup benefit from an additional gift antibiotics to reduce the post-ERCP pancreatitis incidence. Assessment of other post-ERCP complications, such as cholangitis, septicemia, and bacteremia.