UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009112
Receipt number R000010686
Scientific Title Examination of suturing of the wound using endoscopic clips which was made by endoscopic submucosal dissection (ESD) for the colorectal tumor to prevent the complications and accerarate the repair of the dissected area.
Date of disclosure of the study information 2012/10/15
Last modified on 2013/10/15 12:43:05

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Basic information

Public title

Examination of suturing of the wound using endoscopic clips which was made by endoscopic submucosal dissection (ESD) for the colorectal tumor to prevent the complications and accerarate the repair of the dissected area.

Acronym

Efficacy of suturing of the wound using endoscopic clips which was made by ESD for colorectal tumor.

Scientific Title

Examination of suturing of the wound using endoscopic clips which was made by endoscopic submucosal dissection (ESD) for the colorectal tumor to prevent the complications and accerarate the repair of the dissected area.

Scientific Title:Acronym

Efficacy of suturing of the wound using endoscopic clips which was made by ESD for colorectal tumor.

Region

Japan


Condition

Condition

More than 20mm colorectal tumors which can be resected using endoscopy.

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In order to evaluate 1)preventing the complications and 2)accereration of wound healing of dissected area in patients with colorectal tumors after ESD.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Check for complications and repair rate of dissecterd area after ESD.

Key secondary outcomes

Residual rate of the endoscopic clips for sutured the wound after ESD.

Correlation between the size of wound area after ESD and period of complete repair.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

endoscopic clips

Interventions/Control_2

no endoscopic clips

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

A patient who is diagnosed colorectal tumor more than 20mm.

Key exclusion criteria

1. A patient who can not be gained agreement with our informed consent.
2. A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.
3. A patient who can not be resected endoscopic treatment.
4. A patient who is suffered major complications under the endoscopic treatment.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoto Sakamoto

Organization

Juntendo University

Division name

Gastroenterology

Zip code


Address

Hongo 3-1-3, Bunkyo-ku,Tokyo 113-8421,Japan

TEL

03-3813-3111

Email

sakamoto@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taro Osada

Organization

Juntendo University

Division name

Gastroenterology

Zip code


Address

Hongo 3-1-3, Bunkyo-ku,Tokyo 113-8421,Japan

TEL

03-3813-3111

Homepage URL


Email

otaro@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research

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

2012 Year 10 Month 15 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

2010 Year 07 Month 02 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 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

2012 Year 10 Month 15 Day

Last modified on

2013 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010686


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name