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

NCT ID: NCT02492685

Last Updated: 2019-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Gallbladder Polyp

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Contrast enhanced EUS group

Contrast enhanced EUS with quantitative analysis

Group Type EXPERIMENTAL

Quantitative analysis by using the new developed software program VueBox

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Wildner D, Pfeifer L, Goertz RS, Bernatik T, Sturm J, Neurath MF, Strobel D. Dynamic contrast-enhanced ultrasound (DCE-US) for the characterization of hepatocellular carcinoma and cholangiocellular carcinoma. Ultraschall Med. 2014 Dec;35(6):522-7. doi: 10.1055/s-0034-1385170. Epub 2014 Sep 9.

Reference Type BACKGROUND
PMID: 25202903 (View on PubMed)

Saftoiu A, Vilmann P, Dietrich CF, Iglesias-Garcia J, Hocke M, Seicean A, Ignee A, Hassan H, Streba CT, Ioncica AM, Gheonea DI, Ciurea T. Quantitative contrast-enhanced harmonic EUS in differential diagnosis of focal pancreatic masses (with videos). Gastrointest Endosc. 2015 Jul;82(1):59-69. doi: 10.1016/j.gie.2014.11.040. Epub 2015 Mar 16.

Reference Type BACKGROUND
PMID: 25792386 (View on PubMed)

Other Identifiers

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1-2015-0033

Identifier Type: -

Identifier Source: org_study_id

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