UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031512 |
|---|---|
| Receipt number | R000035972 |
| Scientific Title | A pilot study of endoscopic hand-suturing for mucosal defects after colorectal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/02/28 15:26:12 |
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Basic information
Public title
A pilot study of endoscopic hand-suturing for mucosal defects after colorectal endoscopic submucosal dissection
Acronym
NCCH-1717
Scientific Title
A pilot study of endoscopic hand-suturing for mucosal defects after colorectal endoscopic submucosal dissection
Scientific Title:Acronym
NCCH-1717
Region
| Japan |
Condition
Condition
Colorectal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate technical feasibility and safety of endoscopic hand suturing for mucosal defects after colorectal endoscopic submucosal dissection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
successful closure rate
Key secondary outcomes
1. Sustained closure rate post 3-4 days after ESD (only rectum and sigmoid colon)
2. Post-ESD bleeding rate
3. Perforation rate
4. other complication rate
5. procedure time for closure
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
endoscopic hand-suturing (EHS)
for mucosal defects immediately after colorectal 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
1) colorectal adenoma or adenocarcinoma 2-5cm in size scheduled for ESD
2) age20 years old or more
3) PS 0-1
4) obtained written informed consent
Key exclusion criteria
1) high risk of post-ESD bleeding
a) Plt less than 50000/mm3 or PT-INR 2 or more
b) Liver chirrosis Child Pugh score B-C
c) chronic kidney disease needed hemodyalysis
2) unable to discontinue antithrombotic drug according to Japanese guidelines
3) prior abdominal or pelvic surgery
4) prior radiotherapy for abdomen or pelvis
5) thought ineligible by attending endoscopist
4)
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Saito |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
ytsaito@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiichiro Abe |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
seabe@ncc.go.jp
Sponsor or person
Institute
Endoscopy Division, National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Olympus
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 28 | Day |
Last modified on
| 2018 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035972
| 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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| Registered date | File name |
