UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015353
Receipt number R000017861
Scientific Title Efficacy of two balloon radial EUS for esophageal or duodenal lesions
Date of disclosure of the study information 2014/10/06
Last modified on 2014/10/06 20:35:24

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Basic information

Public title

Efficacy of two balloon radial EUS for esophageal or duodenal lesions

Acronym

Two balloon confined EUS

Scientific Title

Efficacy of two balloon radial EUS for esophageal or duodenal lesions

Scientific Title:Acronym

Two balloon confined EUS

Region

Japan


Condition

Condition

Esophageal neoplasia or duodenal neoplasia

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aims to develop the precise diagnosis of esophageal and duodenal neoplasia using radial endoscopic ultrasound sonography (EUS) under sufficient deaerated water and favorable images could be obtained

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The difference of accurate location and precise tumor size between conventional radial EUS and two ballon EUS

Key secondary outcomes

The location of tumor and VAS score (1to4) of clearness of tumor between conventional radial EUS and two ballon EUS


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Making a grasping ring approximately 1 cm in diameter with a thread attached to the tip of a balloon (inner diameter, 10 mm; length, 32 mm) (TOP. Co, Tokyo, Japan) Using grasping forceps, we put the indwelling balloon to the distal side of the lesion. We fitted an identical balloon onto the endoscope itself to occlude both the distal and proximal sides of the lesion. The two balloons were expanded with approximately 10 ml air (balloon diameter: 20 mm); the esophagus, which was between the indwelling balloon and the balloon fitted onto the endoscope, was made into an occluded cavity. After expanded the balloon fitted onto the endoscope, all of the air of occluded cavity was aspirated, and filled with deaerated water. By performing two balloon occlusion radial EUS, diagnosed that the tumor located within the submucosal layer

Interventions/Control_2

Performed conventional radial EUS

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who suffered from esophagealtumor or duodenal tumor.

Key exclusion criteria

Patients who have esophageal or duodenal stenosis.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirohito Mori

Organization

Kagawa university

Division name

Department of Gastroenterology and Neurology

Zip code


Address

1720-1, Miki, Kida, Kagawa ,Japan

TEL

+81-87-891-2156

Email

hiro4884@med.kagawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name kazunori Yamashita

Organization

Ehime Rousai Hospital

Division name

Medical Affairs Division

Zip code


Address

13-27 Minamikomatsubara, Niihama, Ehime 792-8550, Japan

TEL

+81-897-33-6191

Homepage URL


Email

ijikachou@ehimerosai.jp


Sponsor or person

Institute

Kagawa university

Institute

Department

Personal name



Funding Source

Organization

Kagawa university

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 10 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2014 Year 10 Month 03 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 06 Day

Last modified on

2014 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017861


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name