UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001302
Receipt number R000001579
Scientific Title Device selection trial in endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial.
Date of disclosure of the study information 2008/08/20
Last modified on 2015/10/20 23:22:49

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Basic information

Public title

Device selection trial in endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial.

Acronym

Device selection RCT in colorectal ESD.

Scientific Title

Device selection trial in endoscopic submucosal dissection for colorectal epitherial neoplasms: A randomized controlled open trial.

Scientific Title:Acronym

Device selection RCT in colorectal ESD.

Region

Japan


Condition

Condition

colorectal epitherial neoplasm

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of Flush knife compared with Flex knife in colorectal ESD.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Procedure time

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Flex knife group

Interventions/Control_2

Flush knife group

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Intramucosal or minutes submucosal invaded (SM1) colorectal epitherial neoplasms which are larger than 20mm and smaller than 60mm.

Key exclusion criteria

1) SM massive cancer
2) Lesions which are existed on anal canal or in cecum.
3) Patients with hematological abnormality.
4) Patients with severe organ failure
5) Patients without written informed consent
6) Lesions which were thought to be difficult to resect by ESD because of unstable positioning of colonoscope.
7) Others who were thought to be unsuitable by endoscopist.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoji Takeuchi

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Gastrointestinal Oncology

Zip code


Address

3-3 Nakamichi 1-chome, Higashinari-ku, Osaka, Japan

TEL

06-6972-1181

Email

takeuti-yo@mc.pref.osaka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoji Takeuchi

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Gastrointestinal Oncology

Zip code


Address

1-3-3 Nakamichi Higashinari-ku, Osaka, Japan

TEL

06-6972-1181

Homepage URL


Email

takeuti-yo@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases

Institute

Department

Personal name



Funding Source

Organization

None

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

2008 Year 08 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.nature.com/ajg/journal/vaop/ncurrent/abs/ajg2009547a.html

Number of participants that the trial has enrolled


Results

Without increasing adverse events, the endo-knife with a water-jet function efficiently reduced the operation time of colorectal ESD in patients with large superficial neoplasms.

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

2008 Year 03 Month 31 Day

Date of IRB


Anticipated trial start date

2008 Year 04 Month 01 Day

Last follow-up date

2009 Year 03 Month 01 Day

Date of closure to data entry

2009 Year 03 Month 01 Day

Date trial data considered complete

2009 Year 04 Month 01 Day

Date analysis concluded

2009 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 08 Month 06 Day

Last modified on

2015 Year 10 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001579


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name