UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2018 Year 10 Month 17 Day
Date of IRB	2018 Year 04 Month 04 Day
Anticipated trial start date	2018 Year 10 Month 17 Day
Last follow-up date	2021 Year 08 Month 17 Day
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	2022 Year 10 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039386