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NCT01583517 · ClinicalTrials.gov registry record · NA
ERCP in Idiopathic Recurrent Acute Pancreatitis
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 89
- Enrollment target
NCT01583517: Completed NA study, sponsored by Indiana University.
NCT01583517 is a NA study that has completed, run by Indiana University. The registered enrollment target is 89 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01583517, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 89 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- PROCEDURE Sham
- PROCEDURE Biliary sphincterotomy
- PROCEDURE Pancreatobiliary sphincterotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 1997-09 |
| Est. Completion | 2014-10 |
| Phase | NA |
What the finished NCT01583517 record still lists
NCT01583517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Sham is the first listed.
NCT01583517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01583517 about?
NCT01583517 is a clinical study titled "ERCP in 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 ep...
What is the current status of trial NCT01583517?
This trial is currently completed. It is a NA study. The enrollment target is 89 participants. The study started on 1997-09. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01583517?
The interventions under investigation include: Sham (PROCEDURE), Biliary sphincterotomy (PROCEDURE), Pancreatobiliary sphincterotomy (PROCEDURE).
Who is sponsoring clinical trial NCT01583517?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01583517's enrollment target sits among peer trials
89 972nd of 2000 higher than 1,029 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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