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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: Completed NA study of Chronic Pancreatitis, sponsored by The Cleveland Clinic.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 70 participants
Start Date 2005-05
Est. Completion 2007-12
Phase NA
The Cleveland Clinic

688 total trials

What the finished NCT00651053 record still lists

NCT00651053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 687-participant average among 42 other Chronic Pancreatitis trials with a reported enrollment target (90% lower).

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 a single indexed study location in 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.

Similar trials for Chronic Pancreatitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00651053's enrollment target sits among peer trials

70 21st of 42 higher than 22 of 42 other Chronic Pancreatitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Pancreatitis 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 NCT00651053, the US trial registry maintained by the National Library of Medicine. NCT00651053 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.