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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02492685

Enrollment

Registered

2015-07-09

Start date

2015-07-31

Completion date

2017-06-30

Last updated

2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallbladder Polyp

Keywords

Quantitative analysis, contrast enhanced endoscopic ultrasonography

Brief summary

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.

Interventions

DEVICEQuantitative 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Accuracy between visual assessment and quantificational analysis based on surgical pathology	1day

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026