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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022545
Receipt No. 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

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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
Email 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
Email eiji525@yokohama-cu.ac.jp

Sponsor
Institute NTT Medical Center Tokyo
Department of Gastroenterology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025980

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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