An interventional study of NSAID alone and Cryoprevention associated with NSAID in Pancreatitis, Acute, sponsored by Instituto do Cancer do Estado de São Paulo. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Instituto do Cancer do Estado de São Paulo · Not applicable, Interventional, and Prevention
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.
This study aims to evaluate the efficacy of instilling ice-cold distilled water (4ºC to 5ºC) into the second duodenal portion as an adjunct to the standard practice of using NSAIDs, comparing it with a group using NSAIDs only to reduce the incidence of PEP. This is a randomized, sequential, blinded, 1:1 paired clinical trial conducted at a single tertiary center. An initial sample of 530 participants was calculated; considering a 10% drop-out, the final calculation was 583 people. All patients will undergo ERCP under sedation or general anesthesia and will be hydrated intravenously with lactated Ringer's. Rectal administration of NSAIDs (indomethacin 100mg) will be performed for all patients without contraindications. In the intervention group, immediately after the end of the therapeutic ERCP, 250 ml of ice-cold distilled water (4º to 5ºC) will be injected towards the papillary region. The control group will undergo standard ERCP and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 583 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Instituto do Cancer do Estado de São Paulo is the lead sponsor of 91 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.
Procedure: NSAID alone
Standard ERCP, hydration with lactated Ringer's, rectal administration of NSAIDs (indomethacin 100mg), and irrigation of the duodenal papilla with 250 ml of ice-cold distilled water (4º to 5ºC).
Procedure: Cryoprevention associated with NSAID
Standard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.
Standard ERCP, hydration with lactated Ringer's, rectal administration of NSAIDs (indomethacin 100mg), and irrigation of the duodenal papilla with 250 ml of ice-cold distilled water (4º to 5ºC).
Incidence of Post-ERCP Pancreatitis (PEP).
New or worsened abdominal pain consistent with pancreatitis, associated with an elevation of serum amylase or lipase at least 3 times the upper limit of normal
Time frame: Immediately after the procedure until 03 days after the procedure
PEP Severity
Classified as mild, moderate, or severe based on the length of hospital stay and local/systemic complications
Time frame: Day 1 (24 hours post-procedure) and 7 days post-procedure
Cholangitis
Defined by fever, jaundice, and/or leukocytosis with evidence of biliary obstruction or need for reintervention.
Time frame: Day 1 (24 hours post-procedure) and 7 days post-procedure
Bleeding
Clinical evidence of hemorrhage (melena, hematemesis) or drop in hemoglobin \> 2g/dL requiring transfusion or endoscopic/surgical intervention.
Time frame: Day 1 (24 hours post-procedure) and 7 days post-procedure
Perforation
Radiological or surgical evidence of air or luminal content leakage into the abdominal cavity or retroperitoneum.
Time frame: Day 1 (24 hours post-procedure) and Day 7 (7 days post-procedure)
Mortality
Death from any cause up to 90 days after the procedure
Time frame: Up to 90 days post-procedure
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — LGPD
Started Jun 2026 (actual). Primary completion is estimated for Aug 2027, 14 months after the start.
Of 91 non-industry interventional studies with no phase under Pancreatitis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 14 months is below that.
Counting every sponsor, half of 94 studies reached it within 32 months; a quarter within 23 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
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Instituto do Cancer do Estado de São Paulo