Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
ConditionPancreatitis, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto do Cancer do Estado de São Paulo
About this trial
The standard prophylaxis for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is performed with rectal non-steroidal anti-inflammatory drugs (NSAIDs). A recent Japanese study demonstrated the efficacy of irrigating the periampullary region with ice water, however without the concomitant use of NSAIDs. The proposed study is a randomized, single-center, single-blind clinical trial that aims to compare the efficacy of rectal NSAIDs alone versus NSAIDs associated with ice water in the prevention of PEP.
Eligibility criteria
Qualifiers
Patients aged 18 years or older
Clinical indication for ERCP
Presence of native major duodenal papilla without previous manipulation
Ability of the patient or companion to provide informed consent.
Disqualifiers
Contraindication to ERCP (e.g., severe hemodynamic instability, visceral perforation)
Ongoing acute pancreatitis (except mild biliary where ERCP is therapeutic and pain has already resolved)
Inaccessibility of the duodenal papilla (e.g., Gastrectomies with Billroth II and Roux-en-Y reconstruction, or gastroduodenal obstructions)
Pregnant women
Trial design
Treatments tested in this trial
- NSAID alone
- Cryoprevention associated with NSAID
Treatment groups
462 Participants
are divided into 2 treatment groupsSponsors and collaborators
Instituto do Cancer do Estado de São Paulo
Lead sponsor
University of Sao Paulo
Sponsor institution
Source ClinicalTrials.gov