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

Primary Purpose

Gallbladder Polyp

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Quantitative analysis by using the new developed software program VueBox
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallbladder Polyp focused on measuring Quantitative analysis, contrast enhanced endoscopic ultrasonography

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contrast enhanced EUS group

Arm Description

Contrast enhanced EUS with quantitative analysis

Outcomes

Primary Outcome Measures

Accuracy between visual assessment and quantificational analysis based on surgical pathology

Secondary Outcome Measures

Sensitivity between visual assessment and quantificational analysis based on surgical pathology
Specificity between visual assessment and quantificational analysis based on surgical pathology
PPV between visual assessment and quantificational analysis based on surgical pathology
NPV between visual assessment and quantificational analysis based on surgical pathology

Full Information

First Posted
July 1, 2015
Last Updated
March 14, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02492685
Brief Title
Quantificational Enhancement Pattern Analysis Using a Novel Software "Vuebox" of Contrast-enhanced Harmonic Endoscopic Ultrasonography for Differential Diagnosis Between Adenomas and Cholesterol Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
The study plan was cancelled because patient registration was delayed for the trials.
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Polyp
Keywords
Quantitative analysis, contrast enhanced endoscopic ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contrast enhanced EUS group
Arm Type
Experimental
Arm Description
Contrast enhanced EUS with quantitative analysis
Intervention Type
Device
Intervention Name(s)
Quantitative analysis by using the new developed software program VueBox
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accuracy between visual assessment and quantificational analysis based on surgical pathology
Time Frame
1day
Secondary Outcome Measure Information:
Title
Sensitivity between visual assessment and quantificational analysis based on surgical pathology
Time Frame
1 day
Title
Specificity between visual assessment and quantificational analysis based on surgical pathology
Time Frame
1 day
Title
PPV between visual assessment and quantificational analysis based on surgical pathology
Time Frame
1 day
Title
NPV between visual assessment and quantificational analysis based on surgical pathology
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25202903
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.
Results Reference
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PubMed Identifier
25792386
Citation
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.
Results Reference
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Quantificational Enhancement Pattern Analysis Using a Novel Software "Vuebox" of Contrast-enhanced Harmonic Endoscopic Ultrasonography for Differential Diagnosis Between Adenomas and Cholesterol Polyps

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