UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020104
Receipt number R000023182
Scientific Title Mechanism of less frequent hemorrhage after cold polypectomy for colorectal polyps
Date of disclosure of the study information 2015/12/10
Last modified on 2020/08/10 08:04:43

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Basic information

Public title

Mechanism of less frequent hemorrhage after cold polypectomy for colorectal polyps

Acronym

Mechanism of CSP

Scientific Title

Mechanism of less frequent hemorrhage after cold polypectomy for colorectal polyps

Scientific Title:Acronym

Mechanism of CSP

Region

Japan


Condition

Condition

Patients who receive colonoscopic resection

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare histological damage between hot and cold polypectomy

Basic objectives2

Others

Basic objectives -Others

To clarify the mechanism of less frequent hemorrhage after cold polypectomy

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Depth of injury

Key secondary outcomes

Number of injured vessels
Number of remaining intact vessels


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Endoscopically resect colorectal mucosa using two methods (hot or cold),

Interventions/Control_2


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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who are scheduled to receive colorectal resection for cancer

Key exclusion criteria

Poor rsik, ASA 3 or greater
Hemorrhagic diathesis







9

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Kazutomo
Middle name
Last name Togashi

Organization

Fukushima Medical University

Division name

Aizu Medical Center

Zip code

969-3492

Address

Aizuwakamatsu-city

TEL

0242-75-2100

Email

togashik@fmu.ac.jp


Public contact

Name of contact person

1st name Jinko
Middle name
Last name Kobayashi

Organization

Fukushima Medical University

Division name

Aizu Medical Center

Zip code

969-3492

Address

Aizuwakamatsu-city

TEL

0242-75-2100

Homepage URL


Email

jinko-kb@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

Fukushima Medical University

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukushima Medical University

Address

1 Hibarigaoka, Fukushima-city, Fukushima

Tel

024-547-1825

Email

rs@fmu.ac.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

福島県立医科大学会津医療センター附属病院(福島県)


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 10 Day


Related information

URL releasing protocol

DOI: 10.1097/DCR.0000000000001109

Publication of results

Published


Result

URL related to results and publications

DOI: 10.1097/DCR.0000000000001109

Number of participants that the trial has enrolled

15

Results

All cold resections were limited to the shallow submucosa, while 60% of hot resections advanced to the deep submucosa and 20% to the muscularis propria (p<0.001). There was no significant difference in the width of destruction. In hot resections, the number of remaining large vessels had a trend toward fewer (p=0.15) and the depth of remaining submucosa was less (p=0.007). In deep submucosa, the vessel diameter was larger (p<0.001) and the number of large vessels was greater (p=0.018).

Results date posted

2020 Year 08 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients scheduled to undergo colorectal resection

Participant flow

On the day before surgery, 2 mucosal resections (hot and cold) of normal mucosa were performed on each patient using the same snare without saline injection. The difference was only the application of electrocautery or not. Resection sites were placed close to the cancer to be included in the surgical specimen.

Adverse events

None

Outcome measures

The primary outcome measure was the depth of destruction. Secondary outcome measures included the width of destruction, depth of the remaining submucosa, and number of vessels remaining at the resection sites. The number and diameter of vessels in undamaged submucosa were also evaluated.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 06 Month 01 Day

Date of IRB

2014 Year 06 Month 01 Day

Anticipated trial start date

2015 Year 12 Month 10 Day

Last follow-up date

2016 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 02 Month 28 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2017 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 12 Month 07 Day

Last modified on

2020 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023182


Research Plan
Registered date File name
2017/10/10 01 研究計画書(別紙様式1)CSPmechVer5.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name