UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022545 |
|---|---|
| Receipt number | R000025980 |
| Scientific Title | Feasibility study investigating the efficacy and safety of hybeid endoscopic submucosal dissection |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/02/20 12:50:22 |
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Basic information
Public title
Feasibility study investigating the efficacy and safety of hybeid endoscopic submucosal dissection
Acronym
Efficacy and safety of Hybrid-ESD
Scientific Title
Feasibility study investigating the efficacy and safety of hybeid endoscopic submucosal dissection
Scientific Title:Acronym
Efficacy and safety of Hybrid-ESD
Region
| Japan |
Condition
Condition
Colorectal adenoma/intramucosal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of Hybrid-ESD for the treatment of colorectal adenoma/cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Complication rate
assessed after endoscopic treatment
Key secondary outcomes
Procedure time, The rate of adverse events (perforation, delayed bleeding)
These autcomes were assessed one Month after the treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with 20-30mm colorectal adenoma/intramucosal cancer were considered eligible.
Hybrid ESD was performed using newly-developed device which enable scircumferential incision and submucosal dissection.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with 20-30mm colorectal adenoma/intramucosal cancer were consequentially enrolled in the present study.
Key exclusion criteria
We exclude patients with colorectal adenoma/intramucosalcancer larger than 30mm.
Patients whose lesions were found to be outside the guideline or expanded criteria for ESD by the endoscopic characteristics and histological findings of biopsy specimens.
Patients in disagreement with informed consent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Ohata |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
Address
5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL
+81-3-3448-6111
ken.ohata1974@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Sakai |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
Address
5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL
+81-3-3448-6111
Homepage URL
eiji525@yokohama-cu.ac.jp
Sponsor or person
Institute
NTT Medical Center Tokyo
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
This study do not need financial support
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 30 | Day |
Last modified on
| 2019 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025980
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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