NCT01583517

ERCP in Idiopathic Recurrent Acute Pancreatitis

Defining the Role of ERCP in the Evaluation and Treatment of Idiopathic Recurrent Acute Pancreatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Recurrent Acute Pancreatitis

Interventions

Type	Name	Description
PROCEDURE	Biliary sphincterotomy	Cutting of the biliary sphincter muscle.
PROCEDURE	Pancreatobiliary sphincterotomy	Cutting of both the biliary and pancreatic sphincter muscles.
PROCEDURE	Sham	No sphincterotomy is performed in patients randomized to sham with normal SOM.

Timeline

• Start date: 1997-09-01
• Primary completion: 2012-04-01
• Completion: 2014-10-01
• First posted: 2012-04-24
• Last updated: 2014-10-10

Locations

1 site across 1 country: United States