ERCP in Idiopathic Recurrent Acute Pancreatitis
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Recurrent Acute Pancreatitis |
Procedure: Biliary sphincterotomy Procedure: Pancreatobiliary sphincterotomy Procedure: Sham |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Defining the Role of ERCP in the Evaluation and Treatment of Idiopathic Recurrent Acute Pancreatitis |
- Recurrent acute pancreatitis [ Time Frame: 120 months ] [ Designated as safety issue: No ]
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.
- Interval development of chronic pancreatitis [ Time Frame: 120 months ] [ Designated as safety issue: No ]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).
- Secondary assessment of risk factors for developing recurrent acute pancreatitis during follow-up [ Time Frame: 120 months ] [ Designated as safety issue: No ]A post hoc analysis will be conducted to evaluate for independent factors associated with having recurrent acute pancreatitis during follow-up
| Enrollment: | 89 |
| Study Start Date: | September 1997 |
| Estimated Study Completion Date: | August 2016 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Biliary sphincterotomy
Cutting of the biliary sphincter muscle alone
|
Procedure: Biliary sphincterotomy
Cutting of the biliary sphincter muscle.
|
|
Active Comparator: Dual sphincterotomy
Cutting of both the biliary and pancreatic sphincter muscles.
|
Procedure: Pancreatobiliary sphincterotomy
Cutting of both the biliary and pancreatic sphincter muscles.
|
|
Sham Comparator: Sham
Among patients with normal sphincter of Oddi manometry, patients will undergo no sphincterotomy (sham therapy).
|
Procedure: Sham
No sphincterotomy is performed in patients randomized to sham with normal SOM.
|
|
Active Comparator: Biliary sphincterotomy - Normal SOM
Among patients with normal SOM, patients may be randomized to empiric biliary sphincterotomy alone.
|
Procedure: Biliary sphincterotomy
Cutting of the biliary sphincter muscle.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Indiana | |
| Indiana University Health University Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | Stuart Sherman, MD | Indiana University |
More Information
No publications provided by Indiana University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT01583517 History of Changes |
| Other Study ID Numbers: | 1011003897 |
| Study First Received: | April 20, 2012 |
| Last Updated: | April 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
Acute pancreatitis ERCP Sphincterotomy Manometry Sphincter of Oddi dysfunction |
Additional relevant MeSH terms:
|
Pancreatitis Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013