UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020158
Receipt number R000023285
Scientific Title Efficacy of the shortening procedure time and safety under sufficient counter traction using Endoscopic Ring Thread Technique (ERTT)
Date of disclosure of the study information 2015/12/10
Last modified on 2018/12/11 16:21:13

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Basic information

Public title

Efficacy of the shortening procedure time and safety under sufficient counter traction using Endoscopic Ring Thread Technique (ERTT)

Acronym

Efficacy of the ERTT

Scientific Title

Efficacy of the shortening procedure time and safety under sufficient counter traction using Endoscopic Ring Thread Technique (ERTT)

Scientific Title:Acronym

Efficacy of the ERTT

Region

Japan


Condition

Condition

The inclusion criteria of this study's patients who satisfied the following expanded indication inclusion criteria for ESD according to the guidelines of the Japan Gastric Cancer Association
(JGCA) were included. In differentiated gastric cancers, intramucosal carcinoma has no size restriction, whereas intramucosal carcinoma accompanied by ulcer scar and SM1 carcinoma
(500 um from the muscularis mucosae) should be <30 mm. In undifferentiated carcinomas,
intramucosal carcinoma should be <20 mm. Included patients consented to the study
after receiving oral and written explanations.

Classification by specialty

Medicine in general Gastroenterology Surgery in general
Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

During gastric endoscopic submucosal dissection, the clear surgical view is necessary to perform the procedure safely.Under clear view using ERTT enable us to perform ESD without bleeding and perforation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase



Assessment

Primary outcomes

The procedure time of ESD between ERTT group and conventionalgroup

Key secondary outcomes

1.Bleeding during ESD
2.The procerure time of creating ERTT
3.Evaluation of visibility of ERTT using VAS (visual analogue sysytem) score


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Innovative endoscopic counter traction method called ERTT which was made of surgical thread like ring-shaped thread

Interventions/Control_2

Conventional ESD

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

89 years-old >

Gender

Male and Female

Key inclusion criteria

The inclusion criteria of this study's patients who satisfied the following expanded indication inclusion criteria for ESD according to the guidelines of the Japan Gastric Cancer Association
(JGCA) were included. In differentiated gastric cancers, intramucosal carcinoma has no size restriction, whereas intramucosal carcinoma accompanied by ulcer scar and SM1 carcinoma
(500 um from the muscularis mucosae) should be <30 mm. In undifferentiated carcinomas,
intramucosal carcinoma should be <20 mm. Included patients consented to the study
after receiving oral and written explanations.

Key exclusion criteria

Patients who should be removed the lesion by operation

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mori Hirohito

Organization

Kagawa university

Division name

Department of Gastroenterology and Neurology

Zip code


Address

1750-1, Miki, Kida, Kagawa, Japan

TEL

087-891-1256

Email

hiro4884@med.kagawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hayashi Yukari

Organization

Ehime Rousai Hospital

Division name

Medical Affairs Division

Zip code


Address

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

TEL

0897-33-6191

Homepage URL


Email

ijikachou@ehimerosai.jp


Sponsor or person

Institute

Kagawa university

Institute

Department

Personal name



Funding Source

Organization

Ehime rousai hospital

Organization

Division

Category of Funding Organization

Other

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

2015 Year 12 Month 10 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

Completed

Date of protocol fixation

2015 Year 12 Month 10 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 10 Day

Last follow-up date

2018 Year 10 Month 01 Day

Date of closure to data entry

2018 Year 10 Month 19 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 12 Month 10 Day

Last modified on

2018 Year 12 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023285


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name