UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029741
Receipt number R000033978
Scientific Title Usefulness of Transesophageal Echocardiography Probe for the Diagnosis of Digestive Diseases
Date of disclosure of the study information 2018/01/01
Last modified on 2021/04/30 17:32:38

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Basic information

Public title

Usefulness of Transesophageal Echocardiography Probe for the Diagnosis of Digestive Diseases

Acronym

TEE-DD study

Scientific Title

Usefulness of Transesophageal Echocardiography Probe for the Diagnosis of Digestive Diseases

Scientific Title:Acronym

TEE-DD study

Region

Japan


Condition

Condition

esopahgeal and paraesophageal diseases

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluated the usefulness of Transesophageal Echocardiography (TEE) in the esophageal and paraesophageal (lymph nodes, pancreas, liver, etc)diseases.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Differences of the EUS and TEE images and concordance between TEE images and pathology

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

The use of transesophageal echocardiography probe for the diagnosis of digestive diseases

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

Those who have esophageal or paraesophageal diseases which can be deteced by EUS.

Key exclusion criteria

Severe complications
Severe mental disordor
Judement as being ineligible by the principal or subinvestigator.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yoshiki
Middle name
Last name Hirooka

Organization

Nagoya University Hospital

Division name

Department of Endoscopy

Zip code

466-8560

Address

65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560

TEL

052-744-2602

Email

hirooka@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Takuya
Middle name
Last name Ishikawa

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterology

Zip code

466-8560

Address

65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560

TEL

052-744-2602

Homepage URL


Email

ishitaku@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Nagoya University

Address

65 Tsurumai-cho, Showa-ku, Nagoya

Tel

0527441958

Email

center@med.nagoya-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 01 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/32583394/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/30941638/

Number of participants that the trial has enrolled

1

Results

A 72-year-old woman was referred for evaluation of an incidentally found cystic lesion in the tail of the pancreas. The estimated number of patients was 50, but after one case was enrolled, there were no eligible cases and the study was terminated.

Results date posted

2021 Year 04 Month 30 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 02 Month 20 Day

Baseline Characteristics

A 72-year-old woman was referred for evaluation of an incidentally found cystic lesion in the tail of the pancreas.

Participant flow

The estimated number of patients was 50, but after one case was enrolled, there were no eligible cases and the study was terminated.

Adverse events

There were no adverse events related to TEE or EUS.

Outcome measures

The number of enrolled patients did not reach the scheduled number, and the primary and secondary endpoints could not be evaluated.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 10 Month 27 Day

Date of IRB

2018 Year 01 Month 23 Day

Anticipated trial start date

2018 Year 01 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 04 Month 30 Day

Date trial data considered complete

2021 Year 04 Month 30 Day

Date analysis concluded

2021 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 10 Month 27 Day

Last modified on

2021 Year 04 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033978


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name