Pancreatitis, Acute
Conditions
Interventions
This is a two-arm, randomized controlled clinical trial with blinded outcome assessment, conducted at a single tertiary care center. Group 1 – Intervention (Needle-knife fistulotomy): 109 adult patien
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) for the first time; favorable papillary morphology; infundibular bulging of at least 8 mm, with a minimum distance of 3 mm from the papillary orifice and a minimum length of 5 mm for endoscopic incision; age over 18 years; agreement with the Informed Consent Form
Exclusion criteria
Exclusion criteria: Refusal to sign the Informed Consent Form (ICF); previous endoscopic retrograde cholangiopancreatography (ERCP); coagulopathy; surgical history that alters endoscopic access to the biliary tract (e.g., gastrectomy with Billroth II or Roux-en-Y reconstruction); pancreatic sphincterotomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the efficacy (success and cannulation time) for biliary access using needle-knife fistulotomy (NKF) versus conventional cannulation attempt (CC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the safety (incidence of adverse events: pancreatitis, bleeding, cholangitis, and perforation) for biliary access using needle-knife fistulotomy (NKF) versus conventional cannulation attempt (CC). | — |
Countries
Brazil
Contacts
Public ContactMateus Funari
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed