UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034207
Receipt number R000038813
Scientific Title The association between quantity of electricity during ESD and postoperative esophageal stricture formation: a randomized, double-blind, parallel-group trial
Date of disclosure of the study information 2018/09/21
Last modified on 2021/05/28 10:39:21

* 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

The association between quantity of electricity during ESD and postoperative esophageal stricture formation: a randomized, double-blind, parallel-group trial

Acronym

The association between quantity of electricity during ESD and postoperative esophageal stricture formation: a randomized, double-blind, parallel-group trial

Scientific Title

The association between quantity of electricity during ESD and postoperative esophageal stricture formation: a randomized, double-blind, parallel-group trial

Scientific Title:Acronym

The association between quantity of electricity during ESD and postoperative esophageal stricture formation: a randomized, double-blind, parallel-group trial

Region

Japan


Condition

Condition

esophageal tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the association between quantity of electricity during ESD and postoperative esophageal stricture formation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Stenosis rate of esophagus after esophageal ESD

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Low set point of high frequency energy output device

Interventions/Control_2

Normal set point of high frequency energy output device

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

Esophagus tumor which meet indication of esophageal ESD

Key exclusion criteria

1)Patients under the pregnancy or with a history of drug allergy
2)Patients with a serious organ disorder
3)Patients with active infection
4)Post-ESD artificial ulcer of a size of not less than three-forth of the circumference
5)Patients with more than 2 lesions
6)major axis > 50mm
7)A lesion is located in cervical or abdominal esophagus
8)Invasion depth > SM, ly+, V+, HM+, VM+
9)Patients needs prevension therapy (local steroid injection)
10)Patients under steroid treatment
11)Patients with serious complication
12)Patients who are disqualified for the study by medical doctor

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisahiro Matsubara

Organization

Chiba University Hospital

Division name

Esophageal-Gastro-Intestinal Surgery

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN

TEL

043-226-2109

Email

matsuhm@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukiko Yamaguchi

Organization

Chiba University Hospital

Division name

Esophageal-Gastro-Intestinal Surgery

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN

TEL

043-226-2109

Homepage URL


Email

adta4613@chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital
Esophageal-Gastro-Intestinal Surgery

Institute

Department

Personal name



Funding Source

Organization

None

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



Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 21 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

Preinitiation

Date of protocol fixation

2018 Year 06 Month 25 Day

Date of IRB

2018 Year 08 Month 06 Day

Anticipated trial start date

2018 Year 11 Month 11 Day

Last follow-up date

2020 Year 08 Month 07 Day

Date of closure to data entry

2021 Year 03 Month 30 Day

Date trial data considered complete

2021 Year 06 Month 30 Day

Date analysis concluded

2021 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 09 Month 20 Day

Last modified on

2021 Year 05 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038813


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name