NCT01583517

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 1997

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
14.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 10, 2014

Status Verified

October 1, 2014

Enrollment Period

14.6 years

First QC Date

April 20, 2012

Last Update Submit

October 8, 2014

Conditions

Recurrent Acute Pancreatitis

Keywords

Acute pancreatitisERCPSphincterotomyManometrySphincter of Oddi dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Interval development of chronic pancreatitis

    120 months

  • Secondary assessment of risk factors for developing recurrent acute pancreatitis during follow-up

    120 months

Study Arms (4)

Biliary sphincterotomy

ACTIVE COMPARATOR

Cutting of the biliary sphincter muscle alone

Procedure: Biliary sphincterotomy

Dual sphincterotomy

ACTIVE COMPARATOR

Cutting of both the biliary and pancreatic sphincter muscles.

Procedure: Pancreatobiliary sphincterotomy

Sham

SHAM COMPARATOR

Among patients with normal sphincter of Oddi manometry, patients will undergo no sphincterotomy (sham therapy).

Procedure: Sham

Biliary sphincterotomy - Normal SOM

ACTIVE COMPARATOR

Among patients with normal SOM, patients may be randomized to empiric biliary sphincterotomy alone.

Procedure: Biliary sphincterotomy

Interventions

Biliary sphincterotomyPROCEDURE

Cutting of the biliary sphincter muscle.

Biliary sphincterotomyBiliary sphincterotomy - Normal SOM
Pancreatobiliary sphincterotomyPROCEDURE

Cutting of both the biliary and pancreatic sphincter muscles.

Dual sphincterotomy
ShamPROCEDURE

No sphincterotomy is performed in patients randomized to sham with normal SOM.

Sham

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic recurrent acute pancreatitis, defined as two or more episodes requiring hospitalization
  • ERCP with SOM planned

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 22982183RESULT

MeSH Terms

Conditions

PancreatitisSphincter of Oddi Dysfunction

Interventions

Sphincterotomy, Endoscopicsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesBiliary DyskinesiaCommon Bile Duct DiseasesBile Duct DiseasesBiliary Tract Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeEndoscopy, GastrointestinalEndoscopy, Digestive SystemEndoscopyMinimally Invasive Surgical ProceduresSphincterotomyMyotomy

Study Officials

  • Stuart Sherman, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 24, 2012

Study Start

September 1, 1997

Primary Completion

April 1, 2012

Study Completion

October 1, 2014

Last Updated

October 10, 2014

Record last verified: 2014-10

Locations

US(1)