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

Gallbladder Polyp Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02492685
• Other study ID #: 1-2015-0033
• Status: Withdrawn
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gallbladder Polyp
• Polyps

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy between visual assessment and quantificational analysis based on surgical pathology		1day
Secondary	Sensitivity between visual assessment and quantificational analysis based on surgical pathology		1 day
Secondary	Specificity between visual assessment and quantificational analysis based on surgical pathology		1 day
Secondary	PPV between visual assessment and quantificational analysis based on surgical pathology		1 day
Secondary	NPV between visual assessment and quantificational analysis based on surgical pathology		1 day