NCT02492685

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

July 1, 2015

Last Update Submit

March 14, 2019

Conditions

Gallbladder Polyp

Keywords

Quantitative analysiscontrast enhanced endoscopic ultrasonography

Outcome Measures

Primary Outcomes (1)

  • Accuracy between visual assessment and quantificational analysis based on surgical pathology

    1day

Secondary Outcomes (4)

  • 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

Study Arms (1)

Contrast enhanced EUS group

EXPERIMENTAL

Contrast enhanced EUS with quantitative analysis

Device: Quantitative analysis by using the new developed software program VueBox

Interventions

Quantitative analysis by using the new developed software program VueBoxDEVICE

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.

Contrast enhanced EUS group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient who will be received the exams to evaluate the polyps for treatment plan of surgical treatment
  • have a plan to evaluate by EUS
  • years of age or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 25202903BACKGROUND

  • 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.

    PMID: 25792386BACKGROUND
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 9, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

March 18, 2019

Record last verified: 2019-03

Locations

KR(1)