Status:
COMPLETED
Papillary Epinephrine Injection Combined With Rectal Indomethacin
Lead Sponsor:
Duzce University
Conditions:
Post-ERCP Acute Pancreatitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is the most common and one of the most undesirable major adverse events after endoscopic retrograde cholangiopancreatography (ERC...
Detailed Description
Patient characteristics and procedure-related parameters will be recorded. Patients will be divided into two as a patient group and a control group by 1:1 simple randomization. The patients in the in...
Eligibility Criteria
Inclusion
- Patients who submitted a written informed consent for this trial, and aged between 18-80 years old
- Patients who have naïve papilla (no previous procedure was performed at ampulla)
- Patients who is suspected to have a biliary obstruction or biliary disease
- Patients who are needed to have endoscopic retrograde cholangiopancreatography for treatment of biliary obstruction
Exclusion
- Patients who are pregnant
- Patients with mental retardation
- Patients allergic to contrast agents
- Patients who received sphincterotomy or pancreatobiliary operation previously
- Patients who have ampulla of Vater cancer
- Patients who have difficulty with the approach to ampulla due to abdominal surgery including stomach cancer with Billroth II anastomosis
- Patients who have pancreatic diseases as below (at least one more);
- acute pancreatitis within 30days before enrollment
- idiopathic acute recurrent pancreatitis
- pancreas divisum
- obstructive chronic pancreatitis
- pancreatic cancer
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT07173179
Start Date
July 1 2022
End Date
April 1 2023
Last Update
September 15 2025
Active Locations (1)
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1
Duzce University School of Medicine
Düzce, Turkey (Türkiye), 81620