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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025456
Receipt No. R000029297
Scientific Title Evaluation of the efficacy of short-type double balloon endoscopy (DBE) for technically difficult endoscopic submucosal dissection (ESD) in the transverse colon
Date of disclosure of the study information 2017/01/23
Last modified on 2019/07/03

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Basic information
Public title Evaluation of the efficacy of short-type double balloon endoscopy (DBE) for technically difficult endoscopic submucosal dissection (ESD) in the transverse colon
Acronym Efficacy of short-type DBE for ESD in the transverse colon
Scientific Title Evaluation of the efficacy of short-type double balloon endoscopy (DBE) for technically difficult endoscopic submucosal dissection (ESD) in the transverse colon
Scientific Title:Acronym Efficacy of short-type DBE for ESD in the transverse colon
Region
Japan

Condition
Condition The indicated lesion for ESD in the transverse colon
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the efficacy of short-type DBE for ESD in the transverse colon.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Procedure time
Key secondary outcomes Adverse events
En bloc resection

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 The group with single channel endoscope
Interventions/Control_2 The group with short-type double balloon endoscope (EI-580BT)
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 The size of lesion is larger than 2cm and less than 5cm
It is possible to follow the clinical course more than 28 d after ESD
Key exclusion criteria Patients who have hematological abnormality and/or undergoing hemodialysis
Patients who have serious complications
Patients who are considered to be inappropriate for this study by doctors
Patients who have polypoid lesions and/or inflammatory bowel disease
Women who have baby and are pregnant
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hideaki
Middle name
Last name Harada
Organization New Tokyo Hospital
Division name Gastroenterology
Zip code 270-2232
Address 1271 Wanagaya, Matsudo, Chiba 270-2232 Japan
TEL 047-711-8700
Email nerimaendo@hotmail.co.jp

Public contact
Name of contact person
1st name Hideaki
Middle name
Last name Harada
Organization New Tokyo Hospital
Division name Gastroenterology
Zip code 270-2232
Address 1271 Wanagaya, Matsudo, Chiba 270-2232 Japan
TEL 047-711-8700
Homepage URL
Email nerimaendo@hotmail.co.jp

Sponsor
Institute New Tokyo Hospital
Institute
Department

Funding Source
Organization New Tokyo Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization New Tokyo Hospital
Address 1271 Wanagaya
Tel 0477118700
Email nerimaendo@hotmail.co.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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 23 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
2016 Year 12 Month 26 Day
Date of IRB
2017 Year 12 Month 25 Day
Anticipated trial start date
2017 Year 01 Month 18 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 28 Day
Last modified on
2019 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029297

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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