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
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
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
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
