UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047703 |
|---|---|
| Receipt number | R000054276 |
| Scientific Title | Endoscopic hand-suturing (EHS) using a newly designed through the scope needle holder for mucosal defects after colorectal endoscopic submucosal dissection : a multicenter study |
| Date of disclosure of the study information | 2022/05/15 |
| Last modified on | 2023/05/11 18:57:04 |
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Basic information
Public title
Endoscopic hand-suturing (EHS) for mucosal defects after colorectal endoscopic submucosal dissection
Acronym
Endoscopic hand-suturing (EHS) for mucosal defects after colorectal endoscopic submucosal dissection
Scientific Title
Endoscopic hand-suturing (EHS) using a newly designed through the scope needle holder for mucosal defects after colorectal endoscopic submucosal dissection : a multicenter study
Scientific Title:Acronym
Endoscopic hand-suturing (EHS) using a newly designed through the scope needle holder for mucosal defects after colorectal endoscopic submucosal dissection : a multicenter study
Region
| Japan |
Condition
Condition
rectal cancer and sigmoid colon cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the suture retention on postoperative days 3-4 and suture time with a modified flexible needle holder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Suture retention on postoperative days 3-4.
Suture time with a modified flexible needle holder.
Key secondary outcomes
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
Endoscopic hand suturing
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) Patient has a preoperative diagnosis of early-stage rectal cancer or sigmoid colon cancer (including suspected cancer) measuring 2-5 cm
2) Scheduled to undergo ESD
3) At least 20 years old
4) PS 0-1
5) Informed consent has been obtained.
Key exclusion criteria
1) Patients with a bleeding tendency (specifically if the following applies).
*Platelet count less than 50,000/mm3 or PT-INR 2 or higher under non-compliance with anticoagulants.
*Liver cirrhosis, Child-Pugh score B-C.
*Chronic renal failure needs dialysis.
2) Patients who are unable to withdraw antithrombotic medications based on the guidelines.
3) Post-ESD mucosal defects overlying the anal verge.
4) History of abdominal or pelvic surgical resection.
5) History of radiation to the abdominal or pelvic region.
6) Patients whose attending physician determines that participation in this study is inappropriate.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Saito |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
0335422511
ytsaito@ncc.go.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Uozumi |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
0335422511
Homepage URL
tuozumi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Consortium for Advanced Surgical Endoscopy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shizuoka Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
0335422511
ncch-irb@ml.res.ncc.go.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
| 2022 | Year | 05 | Month | 15 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 05 | Month | 10 | Day |
Last modified on
| 2023 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054276
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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