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

Not Applicable

Withdrawn

• Conditions: Gallbladder Polyp
• Interventions: Device: Quantitative analysis by using the new developed software program VueBox

• Registration Number: NCT02492685
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-08
• Study First Posted: 2015-07-09
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast enhanced EUS group	Quantitative analysis by using the new developed software program VueBox	Contrast enhanced EUS with quantitative analysis

Primary Outcome Measures

Name	Time	Method
Accuracy between visual assessment and quantificational analysis based on surgical pathology	1day

Secondary Outcome Measures

Name	Time	Method
Specificity between visual assessment and quantificational analysis based on surgical pathology	1 day
Sensitivity 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
PPV between visual assessment and quantificational analysis based on surgical pathology	1 day

Trial Locations

Locations (1)

Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of