This study aims to further reduce the incidence of a post-ERCP pancreatitis by administrating a single gift antibiotics after the procedure.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pancreatitis na ERCP
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
see primary study parameters
Background summary
An acute pancreatitis is the most common and severe complication of an
endoscopic retrograde cholangiopancreatography (ERCP). Despite standard
non-steroidal anti-inflammatory drug (NSAID) post-ERCP pancreatitis
prophylaxis, still a significant number of patients develop a pancreatitis The
results of previous studies showed that antibiotics before or after the
procedure also reduces the risk of post-ERCP pancreatitis.
Study objective
This study aims to further reduce the incidence of a post-ERCP pancreatitis by
administrating a single gift antibiotics after the procedure.
Study design
The study is a single centre, double blinded randomized controlled trail. It
will be conducted at the Elisabeth-TweeSteden Hospital Tilburg. Every
participant will receive the standard post-ERCP pancreatitis prophylaxis,
diclofenac before the procedure. Participants will be randomized to an
intervention group who will receive a single gift antibiotics intravenous and a
control group who will receive placebo before the ERCP. Patients and
investigators will be blinded for the intervention.
Intervention
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 ERCP.
Study burden and risks
The patients who participate in the study have to undergo an ERCP and will
receive standard NSAIDS prophylaxis before the procedure. In this study
patients receive additional a single gift ceftazidim or NaCl. Antibiotics is
already standard care in some hospitals to prevent post-ERCP pancreatitis.
Because, it is only an one-time gift antibiotics the additional risks related
to the study are negligible.
Hilvarenbekseweg 60
Tilburg 5022 GC
NL
Hilvarenbekseweg 60
Tilburg 5022 GC
NL
Listed location countries
Age
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
• 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
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-000572-37-NL |
| CCMO | NL72967.028.20 |