Health Trials

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • NSAID alone

    Procedure/Surgery

    Standard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.

  • Cryoprevention associated with NSAID

    Procedure/Surgery

    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).

Treatment groups

583 Participants
are divided into 2 treatment groups
Group A: NSAID aloneActive comparator 1 intervention
Group B: Cryoprevention associated with NSAIDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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)

Other outcomes

Sponsors and contacts

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Instituto do Cancer do Estado de São Paulo

Lead sponsor

University of Sao Paulo

Sponsor institution

Source ClinicalTrials.gov
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