NCT07738094 Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
| NCT ID | NCT07738094 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto do Cancer do Estado de São Paulo |
| Condition | Pancreatitis, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 583 participants |
| Start Date | 2026-06-09 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 583 participants in total. It began in 2026-06-09 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Refusal to participate in the study or inability to sign the ICF * Contraindication to NSAID use.
Contact & Investigator
Fauze Maluf Filho
PRINCIPAL INVESTIGATOR
Hospital das Clínicas da Universidade de São Paulo
Frequently Asked Questions
Who can join the NCT07738094 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatitis, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07738094 currently recruiting?
Yes, NCT07738094 is actively recruiting participants. Contact the research team at fauze.maluf@terra.com.br for enrollment information.
Where is the NCT07738094 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07738094 clinical trial?
NCT07738094 is sponsored by Instituto do Cancer do Estado de São Paulo. The principal investigator is Fauze Maluf Filho at Hospital das Clínicas da Universidade de São Paulo. The trial plans to enroll 583 participants.