UMIN-CTR Clinical Trial

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

Colon polyp of endoscopic treatment adapttion

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Southern Tohokou General Hospital

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

総合南東北病院（福島県）

Date of disclosure of the study information

2018

Year

10

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

10

Month

17

Day

Last modified on

2022

Year

10

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039386