Recurrent Acute PancreatitisNCT01583517
ERCP in Idiopathic Recurrent Acute Pancreatitis
A study testing Biliary sphincterotomy and Pancreatobiliary sphincterotomy in people with Recurrent Acute Pancreatitis, run by Indiana University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Acute Pancreatitis
- What is being tested?
- Biliary sphincterotomy and Pancreatobiliary sphincterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1997to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic recurrent acute pancreatitis, defined as two or more episodes requiring hospitalization
- ERCP with SOM planned
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Defining the Role of ERCP in the Evaluation and Treatment of Idiopathic Recurrent Acute Pancreatitis
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).
Read the 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
- Being tested
- Biliary sphincterotomy, Pancreatobiliary sphincterotomy, Sham
- Keywords
- Acute pancreatitis, ERCP, Sphincterotomy, Manometry, Sphincter of Oddi dysfunction
- Medical subject headings
- Pancreatitis, Sphincter of Oddi Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary sphincterotomyProcedure or surgery
Cutting of the biliary sphincter muscle.
Pancreatobiliary sphincterotomyProcedure or surgery
Cutting of both the biliary and pancreatic sphincter muscles.
ShamProcedure or surgery
No sphincterotomy is performed in patients randomized to sham with normal SOM.
| Study group | Role | What they receive |
|---|---|---|
| Biliary sphincterotomy | Active comparator | Cutting of the biliary sphincter muscle alone Receives: Procedure: Biliary sphincterotomy |
| Dual sphincterotomy | Active comparator | Cutting of both the biliary and pancreatic sphincter muscles. Receives: Procedure: Pancreatobiliary sphincterotomy |
| Sham | Sham comparator | Among patients with normal sphincter of Oddi manometry, patients will undergo no sphincterotomy (sham therapy). Receives: Procedure: Sham |
| Biliary sphincterotomy - Normal SOM | Active comparator | Among patients with normal SOM, patients may be randomized to empiric biliary sphincterotomy alone. Receives: Procedure: Biliary sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 months
Secondary outcomes (2)
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).
Measured: 120 months
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
Measured: 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startSep 1997
- Primary completionApr 2012
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Sherman, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583517
- Sponsor's protocol ID
- 1011003897
- Status last verified
- Oct 2014
- First submitted
- 20 Apr 2012
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22982183
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Role of ERCP in the Evaluation and Treatment of Idiopathic Recurrent Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT01583517
- Acronym / sponsor ID
- 1011003897
- Conditions
- Recurrent Acute Pancreatitis
- Keywords
- Acute pancreatitis, ERCP, Sphincterotomy, Manometry, Sphincter of Oddi dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 1997
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biliary sphincterotomy | Active comparator | Procedure: Biliary sphincterotomyCutting of the biliary sphincter muscle alone |
| Dual sphincterotomy | Active comparator | Procedure: Pancreatobiliary sphincterotomyCutting of both the biliary and pancreatic sphincter muscles. |
| Sham | Sham comparator | Procedure: ShamAmong patients with normal sphincter of Oddi manometry, patients will undergo no sphincterotomy (sham therapy). |
| Biliary sphincterotomy - Normal SOM | Active comparator | Procedure: Biliary sphincterotomyAmong patients with normal SOM, patients may be randomized to empiric biliary sphincterotomy alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Idiopathic recurrent acute pancreatitis, defined as two or more episodes requiring hospitalization
- ERCP with SOM planned
Key exclusion criteria (6 listed)
- Chronic pancreatitis
- Pancreas divisum
- Alternate etiology identified (e.g., CBD stone, IPMN)
- Inability to perform pancreatic manometry
- Pregnancy, age < 18, incarceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biliary sphincterotomyCutting of the biliary sphincter muscle. | Procedure or surgery | Biliary sphincterotomy, Biliary sphincterotomy - Normal SOM |
| Pancreatobiliary sphincterotomyCutting of both the biliary and pancreatic sphincter muscles. | Procedure or surgery | Dual sphincterotomy |
| ShamNo sphincterotomy is performed in patients randomized to sham with normal SOM. | Procedure or surgery | Sham |
Primary outcome
Recurrent acute pancreatitis
Time frame: 120 months
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.
2 secondary outcomes
Interval development of chronic pancreatitis
Time frame: 120 months
Secondary assessment of risk factors for developing recurrent acute pancreatitis during follow-up
Time frame: 120 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
- Results publication: PubMed 22982183Cote 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.
Related trials for Recurrent Acute Pancreatitis
RecruitingPhase 1/2
Soy Tomato Juice to Improve Outcomes in Pancreatitis
Recurrent Acute Pancreatitis, Chronic Pancreatitis
Not yet recruitingPhase 4
Varenicline for Smoking Cessation in Pancreatitis
Pancreatitis, Chronic Pancreatitis
Not yet recruiting
Intermittent Fasting for Pancreatitis
Pancreatitis, Pancreatitis, Acute
Recruiting
QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
Chronic Pancreatitis, Chronic Pain
RecruitingPhase 4
Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
Chronic Pancreatitis, Recurrent Acute Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Sherman, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biliary sphincterotomy and Pancreatobiliary sphincterotomy in people with Recurrent Acute Pancreatitis, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent acute pancreatitis (time frame: 120 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01583517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2014.