Clinical trial NCT01583517: ERCP in Idiopathic Recurrent Acute Pancreatitis
Official title: Defining the Role of ERCP in the Evaluation and Treatment of Idiopathic Recurrent Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Acute Pancreatitis
Keywords: Acute pancreatitis
ERCP
Sphincterotomy
Manometry
Sphincter of Oddi dysfunction
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrent acute pancreatitis
timeFrame: 120 months
Secondary outcomes:
measure: Interval development of chronic pancreatitis
timeFrame: 120 months
measure: Secondary assessment of risk factors for developing recurrent acute pancreatitis during follow-up
timeFrame: 120 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Stuart Sherman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cote 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):1502-1509.e1. doi: 10.1053/j.gastro.2012.09.006. Epub 2012 Sep 11.