The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
449
100 mg Indomethacin PR x 1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Number of Patients Who Developed Acute Pancreatitis
Number of patients who developed pancreatitis following ERCP based on Atlanta Classification
Time frame: From randomization to 30 days after ERCP
Number of Patients Who Developed Severe Pancreatitis
Number of patients with severe acute pancreatitis based on the Atlanta Classification
Time frame: From randomization to 30 days after ERCP
Number of Patients Who Developed Moderately Severe Pancreatitis
Number of patients with moderately severe pancreatitis based on Atlanta Classification
Time frame: From randomization to 30 days after ERCP
Number of Patients Who Developed Mild Pancreatitis
Number of patient who developed mild acute pancreatitis based on the Atlanta Classification
Time frame: From randomization to 30 days after ERCP
Number of Patients Who Developed Gastrointestinal Bleeding
Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure
Time frame: From randomization to 30 days after ERCP
Number of Patient Deaths
Number of patients who died from any cause from the time of ERCP until 30 days post-procedure
Time frame: From randomization to 30 days after ERCP
Number of Patients With 30 Days Hospital Re-admission
Number of patients admitted to the hospital for any cause following ERCP
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Time frame: From randomization until 30 days after ERCP