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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000022461
Receipt No. 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

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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
Institute Team "Madowazu"
Institute
Department

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
URL(English) https://upload.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


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