Pancreatitis, Acute
Conditions
Keywords
Post-ERCP Pancreatitis, Cryoprevention, ERCP, NSAIDs
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.
Detailed description
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.
Interventions
PROCEDURENSAID alone
Standard ERCP, hydration with lactated Ringer's, and standard pharmacological prophylaxis (indomethacin 100mg), without the instillation of ice-cold distilled water.
PROCEDURECryoprevention associated with NSAID
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).
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Neither the patients nor the researchers responsible for data extraction and statistical analysis will know which group the patients are assigned to. However, the physicians performing the procedure will not be blinded, as the endoscopist will be operating the device and will therefore be aware of whether or not ice-cold water was used.
Intervention model description
Parallel Assignment (Randomized 1:1 paired clinical trial)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-ERCP Pancreatitis (PEP). | Immediately after the procedure until 03 days after the procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PEP Severity | Day 1 (24 hours post-procedure) and 7 days post-procedure | Classified as mild, moderate, or severe based on the length of hospital stay and local/systemic complications |
| Cholangitis | Day 1 (24 hours post-procedure) and 7 days post-procedure | Defined by fever, jaundice, and/or leukocytosis with evidence of biliary obstruction or need for reintervention. |
| Bleeding | Day 1 (24 hours post-procedure) and 7 days post-procedure | Clinical evidence of hemorrhage (melena, hematemesis) or drop in hemoglobin \> 2g/dL requiring transfusion or endoscopic/surgical intervention. |
| Perforation | Day 1 (24 hours post-procedure) and Day 7 (7 days post-procedure) | Radiological or surgical evidence of air or luminal content leakage into the abdominal cavity or retroperitoneum. |
| Mortality | Up to 90 days post-procedure | Death from any cause up to 90 days after the procedure |
Countries
Brazil
Contacts
CONTACTProf. Dr. Fauze Maluf Filho
CONTACTDr. Mateus Bond Boghossian
PRINCIPAL_INVESTIGATORFauze Maluf Filho
Hospital das Clínicas da Universidade de São Paulo
Outcome results
None listed