Ceftazidim as prophylaxis to reduce the incidence of Post-ERCP pancreatitis.
ID
Bron
Verkorte titel
Aandoening
Post-ERCP pancreatitis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The incidence of post-ERCP pancreatitis. Post-ERCP pancreatitis being defined as the presence of abdominal pain and an increased lipase.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Ceftazidim as prophylaxis to reduce the incidence of Post-ERCP pancreatitis.
Onderzoeksopzet
Week -2, visit 0 (before ERCP), visit 1 (withing 24 hours after procedure), visit 3 (4 weeks after discharge)
Onderzoeksproduct en/of interventie
Ceftazidim or placebo (NaCl 0,9%/10mL)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9453 |
| CCMO | NL72967.028.20 |
| OMON | NL-OMON49650 |