Endoscopic Ultrasound (EUS) Processor Comparison

Prospective Comparison of Two EUS Processors for Imaging of the Pancreas

The primary objective for this study is to compare the image quality of two endoscopic ultrasound (EUS) processors used for imaging of the pancreas. Processor images are used to make a correct clinical diagnosis and higher quality imaging is related to more accurate results. Patient care may be improved due to the information collected as part of this study.

The quality of imaging is of utmost importance for diagnosing early neoplasms in the pancreas and diseases such as chronic pancreatitis. Image quality is dictated by two factors: image resolution and depth of penetration. Good imaging enables diagnosis of early stage disease and thereby facilitates early treatment.

Study Overview

• Status: Withdrawn
• Conditions: Pancreatitis; Pancreatic Carcinoma
• Intervention / Treatment: Other: image quality and resolution; Other: image quality and resolution

Detailed Description

The endoscope is usually connected to a processor that generates an image which is viewed on a monitor. At FH, we use a processor called Aloka 10. A new processor is being developed by Olympus Corporation called EU-ME 2. This new processor is FDA approved, but has not been launched commercially yet. It has been loaned to FH for evaluation. We would like to evaluate this processor in an objective manner and hence the request for study approval.

In this study, the endoscopy during the procedure will be attached to two different processors and images will be generated. The choice of which processor will be used first will be at the discretion of the Endoscopist. This does not require removal and reintroduction of the endoscope into the patient at two occasions. Only the connector will be switched to a different processor. So there is negligible risk to the patient.

The time required for research activities will be between 5-10 minutes. Both processors will be set up in the procedure room for the duration of this study.

The physician will then document the depth of penetration of the image (the farthest structure seen) and image resolution (evaluating the pancreas for subtle abnormalities). Both processors will be used for each patient. The scores for each processor will be documented to a procedure log, using the primary endpoint described above. The CRF will not have any patient information. Images viewed by the physician at the time of procedure will not be saved or recorded as part of this study..

EUS will be performed in the standard fashion by one of the experienced endosonographers in the unit. Once the EUS is complete, the procedure will be stopped and the echoendoscope withdrawn from the patient.

Patients will then be transported to the recovery area for observation as per standard policy. After appropriate observations are deemed satisfactory, patients will be discharged as per unit policy.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreas will be included.

Description

Inclusion Criteria:

All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreas will be included.

Exclusion Criteria:

Age <19 years Unable to safely undergo EUS for any reason

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aloka; image quality and resolution	Other: image quality and resolution; Image quality and resolution will be viewed using Aloka processor; Other Names: Aloka; Other: image quality and resolution; image quality and resolution will be viewed on the EU-me2; Other Names: EU-me2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
image quality	The primary endpoint of the study is to compare processors by assessing image resolution and depth of penetration. This will be accomplished using a objective scoring system assigning one point for each structure visualized. This score will range from 0 to a maximum of 9.	up to 2 months

Collaborators and Investigators

• Sponsor: AdventHealth

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: March 18, 2013
• First Submitted That Met QC Criteria: March 19, 2013
• First Posted (Estimate): March 20, 2013

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Pancreatitis
• Other Study ID Numbers: 409829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO