No registrations found.
ID
Source
Brief title
Health condition
Post-ERCP pancreatitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of post-ERCP pancreatitis. Post-ERCP pancreatitis being defined as the presence of abdominal pain and an increased lipase.
Secondary outcome
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.
Background summary
An acute pancreatitis is the most common and severe complication of an endoscopic retrogade cholangiopancreatography (ERCP). Despite the currently used non-steroidal anti-inflammatory drug (NSAID) prophylaxis, a significant number of patients develop a pancreatitis. The aim of this study is to further reduce the incidence of a post-ERCP pancreatitis (PEP) by administrating a single gift antibiotics before the procedure.
This study is a single centre, double blinded randomized controlled trial. Subjects will receive, according to randomisation, either antibiotics or placebo addiotional to the NSAID before the ERCP procedure.
Study objective
Ceftazidim as prophylaxis to reduce the incidence of Post-ERCP pancreatitis.
Study design
Week -2, visit 0 (before ERCP), visit 1 (withing 24 hours after procedure), visit 3 (4 weeks after discharge)
Intervention
Ceftazidim or placebo (NaCl 0,9%/10mL)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9453 |
| CCMO | NL72967.028.20 |
| OMON | NL-OMON49650 |