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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 is a NA study that has completed, run by Indiana University. The registered enrollment target is 166 participants.
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
Interventions
- PROCEDURE Combined EUS, e-PFT and sEUS Testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2012-09-01 |
| Est. Completion | 2018-02-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01997476
The ClinicalTrials.gov registry entry for NCT01997476 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Combined EUS, e-PFT and sEUS Testing is the first listed.
NCT01997476 reports 0 study locations.
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.
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