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Sponsors and Collaborators: |
The Cleveland Clinic ChiRhoClin, Inc. The National Pancreas Foundation |
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Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00651053 |
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 results to allow the calculation of sensitivity and specificity of linear and radial EUS. Reciever operating characteristics (ROC) analysis will be used to determine the optimal number of EUS criteria for diagnosis.
Condition | Intervention |
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Chronic Pancreatitis |
Procedure: EUS |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Uncontrolled, Crossover Assignment |
Official Title: | Validation of Endoscopic Ultrasound Criteria for Diagnosis of Chronic Pancreatitis Using Dual Secretin and Cholecystokinin Pancreatic Function Testing as Reference Standard |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cleveland Clinic Foundatino ( Tyler Stevens, M.D. ) |
Study ID Numbers: | CRC 2005-01 |
Study First Received: | March 30, 2008 |
Last Updated: | March 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00651053 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Secretin Digestive System Diseases Cholecystokinin |
Pancreatic Diseases Pancreatitis Pancreatitis, Chronic |
Digestive System Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Chronic |