UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059777 |
|---|---|
| Receipt number | R000068352 |
| Scientific Title | A Prospective Study to Evaluate the Applicability of Endoscopic Submucosal Dissection Assisted by a Novel Anchor Ring-Shaped Thread Counter-Traction Method |
| Date of disclosure of the study information | 2025/11/15 |
| Last modified on | 2025/11/14 13:09:02 |
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Basic information
Public title
Feasibility of Endoscopic Submucosal Dissection Using a Novel Anchor Ring-Shaped Thread Counter-Traction Method
Acronym
Novel Anchor Ring-Shaped Thread Counter-Traction ESD
Scientific Title
A Prospective Study to Evaluate the Applicability of Endoscopic Submucosal Dissection Assisted by a Novel Anchor Ring-Shaped Thread Counter-Traction Method
Scientific Title:Acronym
Anchor Ring-Shaped Thread Counter-Traction ESD Study
Region
| Japan |
Condition
Condition
Early malignant tumors of the upper gastrointestinal tract (esophagus, stomach, and duodenum)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the applicability of a novel anchor ring-shaped thread counter-traction method as an adjunctive traction technique for Endoscopic Submucosal Dissection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total procedure time (in minutes) from the start of mucosal incision to completion of lesion resection during Endoscopic Submucosal Dissection assisted by the novel anchor ring-shaped thread counter-traction method.
Key secondary outcomes
1. R0 resection rate:The proportion of lesions in which the pathological evaluation confirms tumor-free horizontal and vertical margins.
2. Incidence of intraoperative adverse events:Complications occurring during Endoscopic Submucosal Dissection, including perforation and bleeding.
3. Incidence of postoperative adverse events:Adverse events occurring after the procedure, such as delayed bleeding, fever, or abdominal pain.
4. Association between lesion characteristics and procedure time:The relationship between lesion size or location and the procedure time influenced by the traction method.
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 Submucosal Dissection assisted by a novel anchor ring-shaped thread counter-traction method. The procedure involves placing an anchoring ring-thread clip on the proximal side of the lesion, advancing a ring-thread clip toward the lesion to provide traction, and performing submucosal dissection under improved visualization until completion of resection.
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
1. Patients with early malignant tumors of the upper gastrointestinal tract (esophagus, stomach, or duodenum) scheduled to undergo Endoscopic Submucosal Dissection in which the novel anchor ring-shaped thread counter-traction method will be applied.
2. Patients who provide written informed consent.
3. No restrictions on age or sex.
Key exclusion criteria
1. Patients deemed to be at high risk for endoscopic treatment (Endoscopic Submucosal Dissection) due to poor general condition or other clinical factors.
2. Patients who do not provide informed consent for participation in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Niida |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Advanced and Innovative Endoscopy
Zip code
791-0295
Address
454 Shitsukawa, Toon City, Ehime, Japan
TEL
0899605308
3naika@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Niida |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Advanced and Innovative Endoscopy
Zip code
791-0295
Address
454 Shitsukawa, Toon City, Ehime, Japan
TEL
0899605308
Homepage URL
3naika@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Kazuki Niida
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-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
| 2025 | Year | 11 | 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
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
| 2025 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2025 | Year | 11 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068352
