Quantificational Enhancement Pattern Analysis Using a Novel Software "Vuebox" of Contrast-enhanced Harmonic Endoscopic Ultrasonography for Differential Diagnosis Between Adenomas and Cholesterol Polyps

March 14, 2019 updated by: Yonsei University
The investigators' study is a prospective study to evaluate the enhancement pattern of contrast-enhanced endoscopic ultrasonography and suggest the criterions for differential diagnosis between gallbladder polyps by using software program of quantitative analysis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient who will be received the exams to evaluate the polyps for treatment plan of surgical treatment
  • have a plan to evaluate by EUS
  • 19 years of age or older

Exclusion Criteria:

  • difficult undergo EUS,
  • allergy for contrast agent,
  • renal failure,
  • acute coronary syndrome
  • pulmonary hypertension, 6) pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Contrast enhanced EUS group
Contrast enhanced EUS with quantitative analysis
Device: Quantitative analysis by using the new developed software program VueBox
After acquiring the EUS image by a regular procedure of EUS and contrast-enhanced with one of the fluoro-gas-containing contrast agents (SonoVue, Bracco, Germany), whole video is recorded on the embedded HDD (hard disk drive) of the US system for later analysis. The videos will be analyzed by using the VueBox software (Bracco Suisse SA, Geneva, Switzerland). After surgical treatment, we will compare the results of quantitative analysis with surgical pathology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy between visual assessment and quantificational analysis based on surgical pathology
Time Frame: 1day
1day

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitivity between visual assessment and quantificational analysis based on surgical pathology
Time Frame: 1 day
1 day
Specificity between visual assessment and quantificational analysis based on surgical pathology
Time Frame: 1 day
1 day
PPV between visual assessment and quantificational analysis based on surgical pathology
Time Frame: 1 day
1 day
NPV between visual assessment and quantificational analysis based on surgical pathology
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2015-0033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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