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The effect of a single gift antibiotics before ERCP to prevent post-ERCP pancreatitis. A study protocol for a single centre, double blinded randomized controlled study.

The effect of a single gift antibiotics before ERCP to prevent post-ERCP pancreatitis. A study protocol for a single centre, double blinded randomized controlled study. - ERCP AB

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49650
Enrollment
500
Registered
2020-08-24
Start date
2021-01-05
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatitis na ERCP infection of pancreas pancreatitis

Interventions

The intervention group receives 2 gram ceftazidim solution in a 10ml syringe intravenous before the ERCP. The control group receives sodium chloride (NaCl) in a 10ml syringe intravenous before the E

Sponsors

Elisabeth-Tweesteden ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients undergoing an elective ERCP at the Elisabeth-TweeSteden hospital Tilburg, who are willing to participate and give informed consent. • Have the minimum age of 18 years or older.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
Primary study parameter is the incidence of post-ERCP pancreatitis the day after the ERCP. Post-ERCP pancreatitis will be defined as the presence of abdominal pain and an increased lipase according to the Cotton criteria. Delayed post-ERCP pancreatitis will be assessed until 4 weeks after the procedure.

Secondary

MeasureTime frame
see primary study parameters

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)