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NCT00651053 · ClinicalTrials.gov registry record · NA
Endoscopic Ultrasound Compared With Pancreatic Function Testing for Diagnosis of Chronic Pancreatitis
A NA study of Chronic Pancreatitis, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT00651053 is a NA study of Chronic Pancreatitis that has completed, run by The Cleveland Clinic. The registered enrollment target is 70 participants, below the 687-participant average among 42 other Chronic Pancreatitis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00651053, a NA study of Chronic Pancreatitis, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a investigator-initiated, single-center, prospective study to evaluate endoscopic ultrasound (EUS) as a diagnostic test for chronic pancreatitis (CP). EUS detects abnormalities of the pancreas that may represent scarring from CP. The validation of any new test requires a comparison with the best available reference standards. There is no true "gold standard" for diagnosis of CP; however, pancreatic function testing (PFT) is highly sensitive for exocrine dysfunction as a surrogate for early fibrosis, and is widely considered the non-histologic gold standard. There are no well-designed prospective studies comparing EUS with PFT as reference standard. EUS detects parenchymal and ductal features of CP said to correlate with fibrosis. We hypothesize that a predominance of parenchymal fibrosis results in diminished acinar-cell secretion of enzymes. Conversely, a predominance of ductal fibrosis results in impairment of ductal secretion of bicarbonate. Because secretin and cholecystokinin (CCK) PFTs measure unique aspects of pancreatic function (duct-cell and acinar-cell function, respectively), the use of both hormonal stimulants will allow the most comprehensive investigation of the significance of EUS features. There are no studies comparing EUS with combined or dual performance of secretin and CCK PFTs. The primary objective of this study is to determine the test characteristics of EUS for diagnosis of CP compared with dual secretin- and CCK- stimulated PFTs as reference standard. Secondary objectives include to: 1. Determine the optimal number and relative functional importance of specific EUS criteria, 2. Compare the test characteristics of linear- and radial-array EUS. 190 patients evaluated for pancreatitis or pancreatic-type abdominal pain will undergo the "new test" (radial and linear EUS) and the reference standard (CCK and secretin PFTs). The EUS examinations will be videotaped and interpreted in a blinded fashion. EUS scores will be compared with PFT
Conditions Studied
Interventions
- DEVICE EUS
Study Locations (1)
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2005-05 |
| Est. Completion | 2007-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00651053
The ClinicalTrials.gov registry entry for NCT00651053 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 687-participant average among 42 other Chronic Pancreatitis trials with a reported enrollment target (90% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Pancreatitis appearing as the primary indexed condition, and to 1 intervention - of which EUS is the first listed.
NCT00651053 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT00651053 about?
NCT00651053 is a clinical study titled "Endoscopic Ultrasound Compared With Pancreatic Function Testing for Diagnosis of Chronic Pancreatitis". This is a investigator-initiated, single-center, prospective study to evaluate endoscopic ultrasound (EUS) as a diagnostic test for chronic pancreatitis (CP). EUS detects abnormalities of the pancreas that may represent scarring from CP. The validation of any new test requires a comparison with the ...
What is the current status of trial NCT00651053?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2005-05. Estimated completion is 2007-12.
What conditions does trial NCT00651053 study?
This clinical trial studies the following conditions: Chronic Pancreatitis.
What interventions are being tested in trial NCT00651053?
The interventions under investigation include: EUS (DEVICE).
Who is sponsoring clinical trial NCT00651053?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00651053 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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