UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007315
Receipt number R000008626
Scientific Title The effectiveness of endoscopic closure for artificial ulcers after colorectal endoscopic submucosal dissection.
Date of disclosure of the study information 2012/02/20
Last modified on 2013/05/13 21:28:50

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Basic information

Public title

The effectiveness of endoscopic closure for artificial ulcers after colorectal endoscopic submucosal dissection.

Acronym

Endoscopic closure for artificial ulcers after colorectal endoscopic submucosal dissection.

Scientific Title

The effectiveness of endoscopic closure for artificial ulcers after colorectal endoscopic submucosal dissection.

Scientific Title:Acronym

Endoscopic closure for artificial ulcers after colorectal endoscopic submucosal dissection.

Region

Japan


Condition

Condition

Colorectal tumors

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of study was to investigate the efficacy of endoscopic closure for artificial ulcer after colorectal ESD.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Patient characteristics and tumor clinicopathologic features , closure completion rate, closure procedure time, and complications et al.

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

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Endoscopic closure for artificial ulcers after colorectal endoscopic submucosal dissection.

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

18 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

The patients with colorectal tumors after ESD were selected and treated in Kagawa university hospital.

Key exclusion criteria

1.The case of incomplete resection 2.The case which occurs a severe complication during operation,3.Difficulties of endoscopic closure,4 The tumor is located at appendix. 5.The patient has sever cardiopulmonary and cerebral diseases. 6.The case which we do not get the informed consent.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shintaro Fujihara

Organization

Kagawa University, Faculty of Medicine

Division name

Department of Gastroenterology and Neurology

Zip code


Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793 Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kagawa University, Faculty of Medicine

Division name

Department of Gastroenterology and Neurology

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Kagawa University, Faculty of Medicine
Department of Gastroenterology and Neurology

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

2012 Year 02 Month 20 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

2011 Year 10 Month 31 Day

Date of IRB


Anticipated trial start date

2011 Year 11 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 02 Month 16 Day

Last modified on

2013 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008626


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name