UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044671 |
|---|---|
| Receipt number | R000051017 |
| Scientific Title | New suture strategy for post-colorectal ESD ulcers using Double loop clips technique and endoscopic string clip suturing: a perspective feasibility study |
| Date of disclosure of the study information | 2021/06/28 |
| Last modified on | 2024/01/06 18:18:09 |
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Basic information
Public title
New suture strategy for post-colorectal ESD ulcers using Double loop clips technique and endoscopic string clip suturing: a perspective feasibility study
Acronym
New suture strategy for post-colorectal ESD ulcers using Double loop clips technique and endoscopic string clip suturing: a perspective feasibility study
Scientific Title
New suture strategy for post-colorectal ESD ulcers using Double loop clips technique and endoscopic string clip suturing: a perspective feasibility study
Scientific Title:Acronym
New suture strategy for post-colorectal ESD ulcers using Double loop clips technique and endoscopic string clip suturing: a perspective feasibility study
Region
| Japan |
Condition
Condition
Colorectal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Consider positively the effectiveness, safety and realizability of the new strategy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effectiveness of new strategy
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 suture
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
Those who can receive endoscopic submucosal exfoliation of colon tumors at our hospital in the future
Key exclusion criteria
(1) Patients with lesions near denture lines and anastomosis
(2) Patients with lesions extending to the end of the ileum
(3) Minors (under 20 years old)
(4) Pregnant patients
(5) Other patients deemed unsuitable as subjects by the research manager
(6) Patients with lesions of 70 mm or more in size
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Abiko |
Organization
Hakodate Municipal Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
0418680
Address
1-Chome Minato-chou
TEL
0138432000
abiko1982@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Abiko |
Organization
Hakodate Municipal Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
041-8680
Address
1-Chome Minato-chou
TEL
0138432000
Homepage URL
abiko1982@gmail.com
Sponsor or person
Institute
Hakodate Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Gastroenterological Endoscopy Society Hokkaido Branch
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
Hakodate Municipal Hospital
Address
1-Chome Minato-chou
Tel
0138432000
abiko1982@gmail.com
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
| 2021 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
34
Results
unpublished
Results date posted
| 2024 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects included 23 males and 10 females. Fifteen (45.5%) of the 33 patients received oral antithrombotic agents and 3 patients (9.1%) received direct oral anticoagulants (DOACs).
Participant flow
A total of 34 patients were enrolled from May 2020 and September 2021 at Hakodate Municipal Hospital. After the exclusion of one patient with noncompletion of ESD (n = 1), 33 patients were analyzed.
Adverse events
PECS occurred in one patient (3.0%), and there was no DB or delayed perforation in any of the patients. Hematochezia that does not fit the definition of DB occurred in one patient (3.0%).
Outcome measures
The en bloc R0 resection rate was 100.0% and the complete ligation rate was 97.0% (32 of the 33 patients).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data analysis in progress.
Management information
Registered date
| 2021 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051017
| 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 |
