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Prevention of Acute Pancreatitis after the Endoscopic Cholangiography procedure with the use of the drug Indomethacin

Prevention of acute Pancreatitis after Endoscopic Retrograde Cholangiopancreatography (ERCP) with Indometacin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5g7hghv
Enrollment
Unknown
Registered
2021-07-29
Start date
2020-04-13
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

Other acute pancreatitis

Interventions

Patients will be randomized into 3 groups, namely: 1) infusion of 0.9% saline solution 100mL with indomethacin 100mg IV, in a single dose, immediately before the procedure (284 patients)
2) administration of 100mg indomethacin via the rectum, in a single dose, immediately before the procedure (284 patients)
and 3) infusion of only 0.9% saline solution 100mL IV, in a single dose, immediately before the procedure. (284 patients). Medications will be administered by the anesthesiologist. The randomization w
E02.319

Sponsors

Serviço de Neurorradiologia do Hospital São José do Complexo Hospitalar Santa Casa de Misericórdia de Porto Alegre
Lead Sponsor
Universidade Federal de Ciências da Saúde de Porto Alegre
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age, who are referred to the Neuroradiology Service of Hospital São José do Complex Santa Casa de Misericórdia of Porto Alegre to perform ERCP who, after due explanations about the study, agree to participate and sign the informed consent form (IC)

Exclusion criteria

Exclusion criteria: Patients with allergy to indomethacin, previous digestive bleeding or a history of peptic ulcer disease, chronic renal failure, biliary prosthesis or previous papillotomy.

Design outcomes

Primary

MeasureTime frame
Reduction in the incidence of post-procedure acute pancreatitis, seen from the presence of abdominal pain in the first 48 hours post-procedure associated with an increase in amylase or lipase in the range of 3 times or more from the upper limit of normality, evaluation in absolute percentage comparing intervention and control groups

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactJúlio Pereira Lima
jpereiralima@terra.com.br+55-051-33038700

Outcome results

None listed

Source: REBEC (via WHO ICTRP)