UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041580
Receipt number R000047459
Scientific Title Prospective observational study on the time of electrocoagulation use during colorectal endoscopic submucosal dissection
Date of disclosure of the study information 2020/08/27
Last modified on 2024/03/03 21:51:13

* 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

Prospective observational study on the time of electrocoagulation use during colorectal endoscopic submucosal dissection

Acronym

Prospective observational study on the time of electrocoagulation use during colorectal endoscopic submucosal dissection

Scientific Title

Prospective observational study on the time of electrocoagulation use during colorectal endoscopic submucosal dissection

Scientific Title:Acronym

Prospective observational study on the time of electrocoagulation use during colorectal endoscopic submucosal dissection

Region

Japan


Condition

Condition

Colorectal tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the difference in the time of electrocoagulation in colorectal ESD between expert and trainee

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Onset of post-ESD electrocoagulation syndrome

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

99 years-old >=

Gender

Male and Female

Key inclusion criteria

Colorectal tumor patients who are eligible for colorectal ESD
Those who are 20 years of age or older at the time of hospitalization

Key exclusion criteria

Patients with metastases
Those who are complicated by intestinal ischemia and necrosis

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Toshiro
Middle name
Last name Kamoshida

Organization

Hitachi General Hospital

Division name

Department of Gastroenterology

Zip code

317-0077

Address

2 Chome-1-1, Hitachi, Ibaraki 317-0077, Japan

TEL

0294231111

Email

toshiro.kamoshida.fu@hitachi.com


Public contact

Name of contact person

1st name Masanori
Middle name
Last name Ochi

Organization

Hitachi General Hospital

Division name

Department of Gastroenterology

Zip code

317-0077

Address

2 Chome-1-1, Hitachi, Ibaraki 317-0077, Japan

TEL

0294231111

Homepage URL


Email

maochi-tei@umin.ac.jp


Sponsor or person

Institute

Hitachi General Hospital

Institute

Department

Personal name



Funding Source

Organization

Hitachi General Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tsuchiura Kyodo General Hospital, Kawasaki Saiwai Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hitachi General Hospital

Address

2 Chome-1-1, Hitachi, Ibaraki 317-0077, Japan

Tel

0294231111

Email

toshiro.kamoshida.fu@hitachi.com


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

株式会社日立製作所日立総合病院(茨城県)、総合病院土浦協同病院(茨城県)、社会医療法人財団石心介川崎幸病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 27 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

2020 Year 08 Month 26 Day

Date of IRB

2020 Year 04 Month 13 Day

Anticipated trial start date

2020 Year 08 Month 26 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design (prospective cohort study), Recruitment method of subjects (Patients who visited our facility after August 26, 2020 and met the selection criteria), Items to be measured (body temperature, abdominal pain, complete blood cell counts, serum chemistry) , Tumor size, invasion depth, ESD time, coagulation time)


Management information

Registered date

2020 Year 08 Month 27 Day

Last modified on

2024 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047459


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name