UMIN-CTR Clinical Trial

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
Institute	Chiba University Hospital Esophageal-Gastro-Intestinal Surgery
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038813