UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018351
Receipt number R000021245
Scientific Title Investigation for shortening of the time required , easiness and psychological stress for hemostasis using new endoscopic imaging technology (Dual Red Imaging)
Date of disclosure of the study information 2015/07/21
Last modified on 2015/07/23 15:15:29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Investigation for shortening of the time required , easiness and psychological stress for hemostasis using new endoscopic imaging technology (Dual Red Imaging)

Acronym

Investigation for shortening of the time required , easiness and psychological stress for hemostasis using Dual Red Imaging (DRI).

Scientific Title

Investigation for shortening of the time required , easiness and psychological stress for hemostasis using new endoscopic imaging technology (Dual Red Imaging)

Scientific Title:Acronym

Investigation for shortening of the time required , easiness and psychological stress for hemostasis using Dual Red Imaging (DRI).

Region

Japan


Condition

Condition

Esophageal cancer, Esophageal intraepithelial neoplasia,gastric cancer, gastric adenoma, colorectal cancer, colorectal adenoma, Barrett's esophageal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the clinical efficacy of Dual Red Imaging (DRI) for the hemostasis in comparison with White Light Imaging (WLI) in ESD, time requited for hemostasis, easiness of hemostasis as well as psychological stress on hemostasis for both technology were evaluated during actual human ESD procedures.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.The average time required for hemostasis by hemostatic forceps in DRI is shorter than that in WLI.
2.The easiness of hemostasis is better in DRI than in WLI.
3. The psychological stress for hemostasis in DRI is lower than that in WLI.

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

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

30 cases
Period:From August 1 2012 until March 19 2014
DRI or WLI was used alternately in between each bleeding occasion until complete hemostasis was achieved. 3 endpoints were assessed for each bleeding occasion.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patient for esophageal cancer, gastric cancer,gastric adenoma, colorectal cancer,colorectal adenoma, Barrett's esophageal cancer, and subjected to esophageal, gastric and colorectal ESD.
2. Patient that an agreement was obtained.

Key exclusion criteria

1. Patient who judged that we were inappropriate to perform examination safely.
2. Patient that an agreement was not obtained.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naohisa Yahagi

Organization

Keio University

Division name

Center for Research and Development of Minimally Invasive Treatment, Cancer Center

Zip code


Address

35 Shinanomachi, Shinjyuku-ku, Tokyo

TEL

03-5363-3437

Email

yahagi-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naohisa Yahagi

Organization

Keio University

Division name

Center for Research and Development of Minimally Invasive Treatment, Cancer Center

Zip code


Address

35 Shinanomachi, Shinjyuku-ku, Tokyo

TEL

03-5363-3437

Homepage URL


Email

yahagi-tky@umin.ac.jp


Sponsor or person

Institute

Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio University

Institute

Department

Personal name



Funding Source

Organization

Center for Research and Development of Minimally Invasive Treatment, Cancer Center, Keio University

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


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 07 Month 21 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Study1; The average time required for hemostasis by dual knife in DRI was statistically shorter than that in WLI (average time; DRI 21sec., WLI 38sec., p=0.01). The average time required for hemostasis by hemostatic forceps in DRI tends to be shorter than that in WLI (average time; Dual Red Imaging 85sec., WLI 101sec., p=0.33).
Study2; The average score of the subjective easiness of hemostasis was significantly lower in WLI than in DRI(average score; DRI 4.3, WLI 3.7, p=0.0008). The easiness of hemostasis is better in DRI than in WLI.
Study3; The average score of the psychological stress for hemostasis in DRI was significantly lower than that in WLI (average score; DRI 1.7, WLI 2.5, p<0.0001).The psychological stress for hemostasis in DRI is lower than that in WLI.

(Presentation at the congress of Digestive Disease Week, May 2014, USA and the 22th Japan Digestive Disease Week, October 2014, Kobe)

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

Main results already published

Date of protocol fixation

2012 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 10 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

2015 Year 07 Month 19 Day

Last modified on

2015 Year 07 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021245


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name