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NCT01997476 · ClinicalTrials.gov registry record · NA

EUS Ductal Evaluation in One Endoscopic Session for the Diagnosis of Exocrine Pancreas Disease

A NA study, sponsored by Indiana University.

Completed
Registry status
NA
Development phase
166
Enrollment target

NCT01997476: Completed NA study, sponsored by Indiana University.

NCT01997476 is a NA study that has completed, run by Indiana University. The registered enrollment target is 166 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01997476, a NA study, has completed, sponsored by Indiana University.

COMPLETED
Registry status
NA
Development phase
166 participants
Enrollment target

Study Summary

The purpose of this study is, to develop a standard of care protocol using the combination of EUS, ePFT, and sEUS during one endoscopic session (instead of the three separate endoscopic sessions). The desired outcome is to diagnose CP and to establish an acceptable protocol for performing this combined technique. It is expected that combining these procedures will eliminate redundant portions of the procedures, reduce repeat visits to the hospital, reduce total recovery time for the patient, and will decrease the associated costs of separate procedures. Chronic pancreatitis (CP) is an irreversible, disease in which the pancreas becomes fibrotic ( thickened and scarred). Symptoms almost always include pain, and as the pancreas becomes progressively more fibrosed (thickened), pancreatic hormonal function is compromised with diarrhea and weight loss. However, while most physicians can readily diagnose patients with severe CP, early CP or "minimal-change" CP is difficult to detect, often due to the lack of radiologic findings, laboratory tests and classic symptoms. As a result, clinicians are searching for diagnostic tools which will allow for earlier, accurate detection of this disease, with the hope that appropriate therapy can be initiated before extensive thickening and scarring of the pancreas occurs. Diagnostic tools to evaluate the pancreas include Endoscopic Ultrasound (EUS), hormone-stimulated endoscopic pancreatic function tests (ePFT) and Secretin stimulated Endoscopic Pancreas Function Test (sPFT) using pancreatic fluid (containing bicarbonate) obtained from the duodenum (the part of the intestine where the stomach opens into the small bowel). EUS is increasingly being used as a diagnostic and treatment tool in pancreatic disease. Currently, hormone-stimulated ePFT is considered the best way to diagnose chronic pancreatitis (long-lasting inflammation and scarring of the pancreas), and removes the need for biopsy or surgery. It is also sensitive in detecting

Primary Outcome

Combined Endoscopic Ultrasound Morphologic Evaluation, Endoscopic Pancreatic Function Testing, and Dynamic EUS Ductal Evaluation before and after Human Secretin Stimulation in one Endoscopic Session for the Diagnosis of Exocrine Pancreas Disease

Interventions

  • PROCEDURE Combined EUS, e-PFT and sEUS Testing

Trial Details

FieldValue
Enrollment Target 166 participants
Start Date 2012-09-01
Est. Completion 2018-02-06
Phase NA
Indiana University

890 total trials

What the finished NCT01997476 record still lists

NCT01997476 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 1 intervention - of which Combined EUS, e-PFT and sEUS Testing is the first listed.

NCT01997476 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01997476 about?

NCT01997476 is a clinical study titled "EUS Ductal Evaluation in One Endoscopic Session for the Diagnosis of Exocrine Pancreas Disease". The purpose of this study is, to develop a standard of care protocol using the combination of EUS, ePFT, and sEUS during one endoscopic session (instead of the three separate endoscopic sessions). The desired outcome is to diagnose CP and to establish an acceptable protocol for performing this combi...

What is the current status of trial NCT01997476?

This trial is currently completed. It is a NA study. The enrollment target is 166 participants. The study started on 2012-09-01. Estimated completion is 2018-02-06.

What interventions are being tested in trial NCT01997476?

The interventions under investigation include: Combined EUS, e-PFT and sEUS Testing (PROCEDURE).

Who is sponsoring clinical trial NCT01997476?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01997476's enrollment target sits among peer trials

166 625th of 2000 higher than 1,375 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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Source: ClinicalTrials.gov NCT01997476, the US trial registry maintained by the National Library of Medicine. NCT01997476 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.