ERCP in Idiopathic Recurrent Acute Pancreatitis

Recurrent Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583517
• Other study ID #: 1011003897
• Status: Completed
• Phase: N/A
• First received: April 20, 2012
• Last updated: October 8, 2014
• Start date: September 1997
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: October 2014
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Idiopathic recurrent acute pancreatitis, defined as two or more episodes requiring hospitalization

• ERCP with SOM planned

Exclusion Criteria:

• Chronic pancreatitis

• Pancreas divisum

• Alternate etiology identified (e.g., CBD stone, IPMN)

• Inability to perform pancreatic manometry

• Pregnancy, age < 18, incarceration

• Inability to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatitis
• Recurrent Acute Pancreatitis

Intervention

Procedure:
• Biliary sphincterotomy
Cutting of the biliary sphincter muscle.
• Pancreatobiliary sphincterotomy
Cutting of both the biliary and pancreatic sphincter muscles.
• Sham
No sphincterotomy is performed in patients randomized to sham with normal SOM.

Locations

Country	Name	City	State
United States	Indiana University Health University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Coté GA, Imperiale TF, Schmidt SE, Fogel E, Lehman G, McHenry L, Watkins J, Sherman S. Similar efficacies of biliary, with or without pancreatic, sphincterotomy in treatment of idiopathic recurrent acute pancreatitis. Gastroenterology. 2012 Dec;143(6):150 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent acute pancreatitis	Patients will be followed post-ERCP for up to 10 years. The primary outcome is development of acute pancreatitis following the index ERCP, based on standard definitions.; Acute pancreatitis is defined as new onset of pancreatic-type abdominal pain with associated elevation in serum amylase or lipase > 3 times the upper limit of normal, OR radiographic findings consistent with acute pancreatitis.	120 months	No
Secondary	Interval development of chronic pancreatitis	Determine the incidence of chronic pancreatitis during prolonged follow-up. Chronic pancreatitis is defined as characteristic changes on cross sectional imaging (CT or MRI/MRCP) or ERP (Cambridge classification).	120 months	No
Secondary	Secondary assessment of risk factors for developing recurrent acute pancreatitis during follow-up	A post hoc analysis will be conducted to evaluate for independent factors associated with having recurrent acute pancreatitis during follow-up	120 months	No