Clinical study to verify the effectiveness of two drugs to prevent inflammation of the Pancreas after performing the Endoscopic Retrograde Cholangiopancreatography procedure

Prophylaxis for Acute Pancreatitis after Endoscopic Retrograde Cholangiopancreatography (ERCP): clinical, randomized, double-blind trial to evaluate the efficacy of Diclofenac versus Indomethacin and the benefit in risk groups

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-10nnzgqh

Enrollment

Unknown

Registered

2023-10-03

Start date

2023-05-15

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Pancreatitis

Interventions

This is a 3 arm, double-blind, randomized controlled clinical trial. A total of 501 people who underwent endoscopic retrograde cholangiopancreatography - ERCP will be selected. These people are at add

1) 167 people who will receive diclofenac 100mg anti-inflammatory suppository

2) 167 people who will receive indomethacin 100mg anti-inflammatory suppository

3) 167 people in the placebo group (non-interventional control). Both the researchers who will evaluate the outcomes and the participants will not know which group each participant belongs to (double

D27.505.696.663.850.014.040.500

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients submitted to Endoscopic Retrograde Cholangiopancreatography; of both sexes; aged over 18 years

Exclusion criteria

Exclusion criteria: Patients under 18 years of age; pregnant women; nursing mothers; those who do not accept or are not able to perform the Endoscopic Retrograde Cholangiopancreatography Exam(s) and follow-up during the study; Patients who lost clinical and laboratory follow-up due to hospital transfer or early death from severe cholangitis; patients with Non-steroidal anti-inflammatory drugs (NSAID) allergy and contraindication for use (i.e., active peptic ulcer, serum creatinine >1.4mg/dL, and single kidney) will also be excluded

Design outcomes

Primary

Measure	Time frame
It is expected to identify which non-steroidal anti-inflammatory drug (NSAID) used in this study is more effective in preventing the development of acute pancreatitis after endoscopic retrograde cholangiopancreatography. For this, a randomized, double-blind study model will be used and the NSAIDs used will be Diclofenac and Indomethacin	—

Secondary

Measure	Time frame
No secondary outcomes expected	—

Countries

Brazil

Contacts

Public ContactGustavo Gurian

Faculdade de Medicina de Sao Jose do Rio Preto

gustavo_gurian@hotmail.com+5511953069741

Outcome results

None listed

Source: REBEC (via WHO ICTRP)