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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
