UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022461
Receipt number R000025469
Scientific Title Efficacy of cold snare polypectomy for the patients taking anticoagulants; Prospective, open label, randomized controlled trial.
Date of disclosure of the study information 2016/06/01
Last modified on 2019/12/01 00:32:53

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Basic information

Public title

Efficacy of cold snare polypectomy for the patients taking anticoagulants; Prospective, open label, randomized controlled trial.

Acronym

Randomized controlled trial for cold snare polypectomy in patients taking anticoagulants.

Scientific Title

Efficacy of cold snare polypectomy for the patients taking anticoagulants; Prospective, open label, randomized controlled trial.

Scientific Title:Acronym

Randomized controlled trial for cold snare polypectomy in patients taking anticoagulants.

Region

Japan


Condition

Condition

Non-pedunculated subcentimetric colorectal polyp (adenoma or sessile serrated adenoma/polyp)

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the safety and efficacy of cold snare polypectomy under taking anticoagulants compared with hot snare polypectomy with heparinization.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

Procedure related immediate and delayed bleeding rate.

Key secondary outcomes

Hematochezia rate (not requiring endoscopic hemostasis), Immediate bleeding rate, Mean procedure time, Mean hospitalization (for subcentimetric polyp, for all polyps), Number of total colonoscopy for clean colon, Adverse event.


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

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Cold snare polypectomy for subcentimetric colorectal polyp taking anticoagulants

Interventions/Control_2

Hot snare polypectomy for subcentimetric colorectal polyp with heparinization

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Patients who has subcentimetric colorectal polyp
2.Patients taking anticoagulant
3.Patients agreed to participate to the study after informed consent.
4.PS, 0,1
5.Plt, normal range.
Cre, less than2.0mg/dl
PT % more than 70% (In case of patients taking warfarin, the range of PT-INR should be within 1.5-3.0)

Key exclusion criteria

1.Previous enrollment to this study.
2.Inflammatory bowel disease, polyposis patient.
3.Polyps larger than 10mm, lesions suspicious for cancer, pedunculate type polyp, or depressed type polyp.
4.Patients taking steroid, anti platelet, multiple anticoaglants.
5.Non-correctable coagulopathy
6.Pregnancy or lactating
7.Psychiatric disorder
8.Active infection
9.Non-correctable hypertention
10.Chronic respiratory failure
11.Undergo artificial dialysis
12.Inappropriate to participate to the study

Target sample size

180


Research contact person

Name of lead principal investigator

1st name Yoji
Middle name
Last name Takeuchi

Organization

Osaka International Cancer Institute

Division name

Gastrointesitnal Oncology

Zip code

5418567

Address

3-1-69 Otemae, Chuo-ku, Osaka, Japan.

TEL

06-6945-1181

Email

takeuti-yo@mc.pref.osaka.jp


Public contact

Name of contact person

1st name Yoji
Middle name
Last name Takeuchi

Organization

Osaka International Cancer Institute

Division name

Gastrointesitnal Oncology

Zip code

5418567

Address

3-1-69 Otemae, Chuo-ku, Osaka, Japan.

TEL

06-6945-1181

Homepage URL


Email

takeuti-yo@mc.pref.osaka.jp


Sponsor or person

Institute

Team "Madowazu"

Institute

Department

Personal name



Funding Source

Organization

The Japanese Gastroenterological Association

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka International Cancer Institute

Address

3-1-69 Otemae, Chuo-ku, Osaka, Japan.

Tel

06-6945-1181

Email

matsumotochi@opho.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

大阪府立成人病センター, 国立病院機構 函館病院, 国立病院機構 東京医療センター, NTT東日本札幌病院, 石川県立中央病院, 佐野病院, 京都第二赤十字病院, 静岡県立静岡がんセンター, 倉敷中央病院, 那覇市立病院, 国立病院機構大阪医療センター, 手稲渓仁会病院, 市立奈良病院, 市立吹田病院, 日本赤十字社和歌山医療センター, 大阪府立急性期・総合医療センター, 熊本大学, 札幌東徳洲会病院, 日本大学, 多根総合病院, 国立がん研究センター中央病院, 兵庫医科大学, 栃木県立がんセンター, 大阪市立総合医療センター, 九州医療センター, 近畿大学, がん研究所有明病院, 宇都宮記念病院, 明石医療センター,関西労災病院                     


Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 01 Day


Related information

URL releasing protocol

https://annals.org/aim/article-abstract/2738160/continuous-anticoagulation-cold-snare-polypectomy-ve

Publication of results

Published


Result

URL related to results and publications

https://annals.org/aim/article-abstract/2738160/continuous-anticoagulation-cold-snare-polypectomy-ve

Number of participants that the trial has enrolled

184

Results

The incidence of polypectomy-related major bleeding in the HB+HSP and CA+CSP groups was 12.0% (95% CI, 5.0% to 19.1%) and 4.7% (CI, 0.2% to 9.2%), respectively. The intergroup difference for the primary end point was +7.3% (CI, -1.0% to 15.7%), with a 0.4% lower limit of 2-sided 90% CI, demonstrating the noninferiority of CA+CSP. The mean procedure time for each polyp and the hospitalization period were longer in the HB+HSP than in the CA+CSP group.

Results date posted

2019 Year 12 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Baseline characteristics between two groups were not significantly different.

Participant flow

A total of 184 patients were enrolled: 90 in the HB+HSP group, 92 in the CA+CSP group, and 2 who declined to participate after enrollment.

Adverse events

There was no thrombotic events.

Outcome measures

The incidence of polypectomy-related major bleeding in the HB+HSP and CA+CSP groups was 12.0% (95% CI, 5.0% to 19.1%) and 4.7% (CI, 0.2% to 9.2%), respectively. The intergroup difference for the primary end point was +7.3% (CI, -1.0% to 15.7%), with a 0.4% lower limit of 2-sided 90% CI,

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 05 Month 17 Day

Date of IRB

2016 Year 03 Month 31 Day

Anticipated trial start date

2016 Year 06 Month 01 Day

Last follow-up date

2018 Year 04 Month 25 Day

Date of closure to data entry

2018 Year 09 Month 30 Day

Date trial data considered complete

2018 Year 10 Month 31 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 05 Month 26 Day

Last modified on

2019 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025469


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/05/01 C-PAC trial(ユーミン登録用)道下追記20180427.xlsx