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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042497
Receipt No. R000048500
Scientific Title New method of closing an artificial defect for a prevention of complications after rectal endoscopic submucosal dissection: Endoscopic ligation with O-ring closure
Date of disclosure of the study information 2020/11/20
Last modified on 2020/11/19

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Basic information
Public title New method of closing an artificial defect for a prevention of complications after rectal endoscopic submucosal dissection: Endoscopic ligation with O-ring closure
Acronym New method of closing an artificial defect for a prevention of complications after rectal endoscopic submucosal dissection: Endoscopic ligation with O-ring closure
Scientific Title New method of closing an artificial defect for a prevention of complications after rectal endoscopic submucosal dissection: Endoscopic ligation with O-ring closure
Scientific Title:Acronym New method of closing an artificial defect for a prevention of complications after rectal endoscopic submucosal dissection: Endoscopic ligation with O-ring closure
Region
Japan

Condition
Condition rectal neoplasia
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate a preventive effect of endoscopic ligation with O-ring closure for delayed complications after rectal endoscopic submucosal dessection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the bleeding rate after rectal endoscopic submucosal dissection
Key secondary outcomes 1)complete closure rate
2)delayed perforation rate
3)total closure time
4)Wound separation rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 To perform endoscopic ligation with O-ring closure for an artificial defect after rectal endoscopic 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients that needed rectal endoscopic submucosal dissection like below
1)a tumor that en bloc resection is difficult by endoscopic mucosal resection like below
LST-NG, especially pseudo-depressed type, the lesion that has a type of Vi pit pattern, shallow submucosal invasion, a large elevated lesion suspected cancer,
2)an intramural tumor with fibrosis of submucosal layer
3)a tumor caused by chronic inflammation such as ulcerative colitis
4)a residual tumor after endoscopic resection
Key exclusion criteria a rectal tumor extending to anal canal over 10% of all
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Naoya
Middle name
Last name Tada
Organization Faculty of Medicine, Kagawa University
Division name Department of Gastroenterology and Neurology
Zip code 761-0793
Address 1750-1 Ikenobe, Miki, Kita, Kagawa, Japan
TEL 087-891-2156
Email n-tada@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name Naoya
Middle name
Last name Tada
Organization Faculty of Medicine, Kagawa University
Division name Department of Gastroenterology and Neurology
Zip code 761-0793
Address 1750-1 Ikenobe, Miki, Kita, Kagawa, Japan
TEL 087-891-2156
Homepage URL
Email n-tada@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University
Institute
Department

Funding Source
Organization N/A
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 Faculty of Medicine, Kagawa University
Address 1750-1 Ikenobe, Miki, Kita, Kagawa, Japan
Tel 087-891-2156
Email n-tada@med.kagawa-u.ac.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
2020 Year 11 Month 20 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 Enrolling by invitation
Date of protocol fixation
2020 Year 07 Month 09 Day
Date of IRB
2020 Year 07 Month 09 Day
Anticipated trial start date
2020 Year 07 Month 09 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 19 Day
Last modified on
2020 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048500

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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