UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030129
Receipt number R000034393
Scientific Title A retrospective study for the usefulness of cold polypectomy compared to conventional polypectomy for colorectal polyps
Date of disclosure of the study information 2017/11/28
Last modified on 2020/05/30 12:59:43

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Basic information

Public title

A retrospective study for the usefulness of cold polypectomy compared to conventional polypectomy for colorectal polyps

Acronym

A retrospective study for the usefulness of cold polypectomy

Scientific Title

A retrospective study for the usefulness of cold polypectomy compared to conventional polypectomy for colorectal polyps

Scientific Title:Acronym

A retrospective study for the usefulness of cold polypectomy

Region

Japan


Condition

Condition

Colorectal polyp

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness and recurrence of cold polypectomy for diminutive polyps compared to conventional polypectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of recurrence more than 1 year after cold polypectomy

Key secondary outcomes

Delayed bleeding, Immediate bleeding rate required hemostatic clipping, pathological investigation(complete resection rate, range of resection) and the rate of the patients with anticoagulant drug


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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)Patients with non-pedunculated polyps<10mm
2)Written informed consent

Key exclusion criteria

1)polyps the size is more than 10mm
2)pedunculated polyps
3)previous chemotherapy and radiotherapy for colorectal cancer
4)others

Target sample size

200


Research contact person

Name of lead principal investigator

1st name TAKESHI
Middle name
Last name YAMAMURA

Organization

Nagoya University Graduate school of medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

4668550

Address

Tsuruma-cho

TEL

0527442172

Email

tyamamu@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name TAKESHI
Middle name
Last name YAMAMURA

Organization

Nagoya University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

4668550

Address

Tsuruma-cho

TEL

0527442172

Homepage URL


Email

tyamamu@med.nagoya-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology

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

Ethics Committee of Nagoya University

Address

65, Tsuruma-cho, Shouwa-ku, Nagoya

Tel

052-741-2111

Email

ethics@med.nagoya-u.ac.jp


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

2017 Year 11 Month 28 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

Suspended

Date of protocol fixation

2015 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 01 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The aim of this study is to evaluate the long-term prognosis of cold polypectomy by follow-up colonoscopy more than one year after.


Management information

Registered date

2017 Year 11 Month 27 Day

Last modified on

2020 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034393


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name