UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020211
Receipt number R000023006
Scientific Title The usefulness of out-patients endoscopic resection using cold snare polypectomy : a randomized controlled trial
Date of disclosure of the study information 2015/12/15
Last modified on 2017/02/22 18:46:57

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Basic information

Public title

The usefulness of out-patients endoscopic resection using cold snare polypectomy : a randomized controlled trial

Acronym

The usefulness of cold snare polypectomy for the out-patients

Scientific Title

The usefulness of out-patients endoscopic resection using cold snare polypectomy : a randomized controlled trial

Scientific Title:Acronym

The usefulness of cold snare polypectomy for the out-patients

Region

Japan


Condition

Condition

Colonic polyps

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare late bleeding rates between cold and hot snare polypectomy among the out-patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

late bleeding rate after polypectomy

Key secondary outcomes

Resection time. Endoscopic complete resection rate. bleeding rate of polyp size, polyp location, antithrombotic drug. negative cut end rate.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Cold snare polypectomy

Interventions/Control_2

EMR

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. The patients with colonic polyps which were subjected to endoscopic resection
2. The patients whose ECOG performance status should be 0 or 1
3. The patients with age 20 years old
4. The patients who gave written informed consent

Key exclusion criteria

1. The patients with serious underlying disorders
2. The patients that were determined to be inappropriate to participate in the study by the investigators

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Suketo Sou

Organization

Tobata Kyoritsu Hospital

Division name

Department of gastroenterology

Zip code


Address

2-5-1 Sawami Tobata-ku Kitakyuushu-city Fukuoka

TEL

093-871-5421

Email

k.ohtsu0120@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kensei Ohtsu

Organization

Tobata Kyoritsu Hospital

Division name

Department of gastroenterology

Zip code


Address

2-5-1 Sawami Tobata-ku Kitakyuushu-city Fukuoka

TEL

093-871-5421

Homepage URL


Email

k.ohtsu0120@gmail.com


Sponsor or person

Institute

Tobata Kyoritsu Hospital

Institute

Department

Personal name



Funding Source

Organization

Tobata Kyoritsu 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 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

Completed

Date of protocol fixation

2015 Year 11 Month 24 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2016 Year 12 Month 19 Day

Date analysis concluded

2017 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 12 Month 15 Day

Last modified on

2017 Year 02 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023006


Research Plan
Registered date File name
2016/10/19 臨床研究実施計画書.docx

Research case data specifications
Registered date File name
2016/10/19 CRF.docx

Research case data
Registered date File name