Recurrent Acute Pancreatitis Clinical Trial
Official title:
Defining the Role of ERCP in the Evaluation and Treatment of Idiopathic Recurrent Acute Pancreatitis
The therapeutic impact of ERCP with sphincterotomy in the management of patients with idiopathic recurrent acute pancreatitis (RAP) needs further study. The investigators conducted a single center, feasibility, randomized trial to determine 1) the role of pancreatic manometry in predicting future episodes of RAP and 2) differences in the efficacy of no, biliary (BES) or pancreatobiliary (dual) endoscopic sphincterotomy (DES).
Patients with idiopathic RAP, defined as ≥2 unexplained (per the treating physician)
episodes of acute pancreatitis (based on standard criteria) requiring hospitalization, will
be prospectively enrolled. All patients will undergo ERCP with manometry, with stratified
randomization based on the assessment of pancreatic basal sphincter pressure. If <40mmHg,
the patient will be randomized to sham or biliary sphincterotomy (BES). If ≥40mmHg, the
patient will be randomized to BES or pancreatobiliary ("dual") sphincterotomy (DES).
Patients and physicians will not be blinded to the assignment group. Patients will be
followed for up to 10 years to determine 1) incidence of RAP requiring hospitalization
(using standard definitions) or 2) interval development of chronic pancreatitis (CP).
Differences between patients who did and did not develop RAP during follow-up will be
compared to evaluate for factors associated with AP during follow-up.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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