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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034550
Receipt No. R000039386
Scientific Title Proportion of complete muscularis mucosae resection by cutting hot snare polypectomy: a randomized controlled trial
Date of disclosure of the study information 2018/10/17
Last modified on 2018/10/17

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Basic information
Public title Proportion of complete muscularis mucosae resection by cutting hot snare polypectomy: a randomized controlled trial
Acronym Proportion of complete muscularis mucosae resection by cutting hot snare polypectomy
Scientific Title Proportion of complete muscularis mucosae resection by cutting hot snare polypectomy: a randomized controlled trial
Scientific Title:Acronym Proportion of complete muscularis mucosae resection by cutting hot snare polypectomy
Region
Japan

Condition
Condition Colon polyp of endoscopic treatment adapttion
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Consideration of effectiveness for Hot Snare Polypectomy (Cutting HSP; C-HSP) using the incision wave
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The ratio of completely resected the muscularis mucosa just under the lesion by the pathological specimen
Key secondary outcomes 1) Ratio of acknowledging CSDPs after resection
2)
3)
4)
5) Average time of hemostasis
6) Ratio of bleeding which was required intraoperative hemostasis just after of polypectomy
7) Incidence of uncontrolled intraoperative bleeding
8) Ratio of postoperative bleeding
9) Ratio of adverse event occurrence

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Hot Snare Polypectomy (C-HSP)
Interventions/Control_2 Cold snare polypectomy(CSP)
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) Persons whose age at agreement acquisition is between 20 and 80 years old.
2) Person who has a sessile or flat type lesion of 6 mm or more and less than 10 mm in the colonoscopy exam performed at our hospital in the past year.
3) Person who got document agreement by his/her free will after fully understanding after participating in this research.
4) People whose PS (ECOG) is either 0 or 1.
5) Clinical inspection test within 28 days of registration date, who satisfy all the conditions as below.
Number of platelets >= 100,000/microL
Serum creatinine value <= 2.0 mg/dL
PT (%) >= 40% or more.
6) Person who can track the progress of 28 days after treatment.
Key exclusion criteria 1) Person who has registered history in this exam.
2) Persons diagnosed with inflammatory bowel disease, colon polyposis.
3) Lesions of 10 mm or more, lesions suspected of cancer, those who are known to have pedunculated and depressed lesions in advance.
4) Persons undergoing continuous systemic administration of steroids and antithrombotics.
5) Persons with blood coagulation function disorder.
6) During pregnancy Persons who are likely to become pregnant or who are lactating.
7) Persons who are merging psychosis or psychiatric symptoms and who seem to be difficult to participate in the exam.
8) Persons who have active bacterial and fungal infection complications (having a fever> 38.5 degrees and suggesting bacterial infection by imaging diagnosis or bacteriologic examination).
9) Persons who are merging uncontrolled high-blood pressure.
10) Persons who have respiratory diseases requiring sustained oxygen administration.
11) Persons who are in dialysis.
12) Others who judged that the doctor in charge is inappropriate as the research subject
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryota Koyanagi
Organization Southern Tohokou General Hospital
Division name Gastroenterology
Zip code
Address Yatsuyamada 7-161, Koriyama, Fukushima
TEL 024-934-5322
Email ryota.koyanagi@mt.strins.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masatake Tamaki
Organization Japan Society of Clinical Research
Division name Director
Zip code
Address Osaka Ekimae 4th building 10F Umeda 1-11-4-1000, Kita-ku, Osaka
TEL 06-6131-5495
Homepage URL
Email tamaki@japanscr.org

Sponsor
Institute Southern Tohokou General Hospital
Institute
Department

Funding Source
Organization self funding
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
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 総合南東北病院(福島県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 17 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 17 Day
Last modified on
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039386

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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