UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057162 |
|---|---|
| Receipt number | R000065342 |
| Scientific Title | Efficacy and safety of different traction numbers in endoscopic submucosal dissection: a retrospective comparative study |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/03/28 23:38:18 |
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Basic information
Public title
Efficacy and safety of different traction numbers in endoscopic submucosal dissection: a retrospective comparative study
Acronym
Efficacy and safety of different traction numbers in endoscopic submucosal dissection: a retrospective comparative study
Scientific Title
Efficacy and safety of different traction numbers in endoscopic submucosal dissection: a retrospective comparative study
Scientific Title:Acronym
Efficacy and safety of different traction numbers in endoscopic submucosal dissection: a retrospective comparative study
Region
| Japan |
Condition
Condition
Colorectal Tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Colorectal endoscopic submucosal dissection (ESD) remains challenges, such as limited visualization and prolonged procedure time persist. Single-point traction enhances dissection efficiency, but has limitations, including diminished traction efficacy over time and the need for repositioning. We developed a novel multi-point traction device to provide stable and convergent traction. This study aimed to compare the efficacy and safety of non-traction, single-point traction, and multi-point traction for colorectal ESD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the lesion resection speed, calculated as the resected area divided by the resection time.
Key secondary outcomes
Secondary outcomes included the overall procedure time, volume of injection per unit area, en bloc resection rate, R0 resection rate, and incidence of complications such as perforation and postoperative bleeding.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be selected.
･Patients admitted to the Department of Gastroenterology between January 1, 2019 and December 31, 2024
･Patients who underwent endoscopic submucosal dissection for colorectal tumor
･Cases in which endoscopic submucosal dissection was performed by a surgeon with more than 400 cases of experience
･20 years of age or older
･Gender is irrelevant
･Patients who have given consent to participate in this study
Key exclusion criteria
Patients who meet the following criteria will be excluded from the study.
･Patients whom the investigator determines to be inappropriate as research subjects
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Okamura |
Organization
Nagasaki Habor Medical Center
Division name
Gastroenterorlogy
Zip code
850-8555
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
TEL
0958223251
taku.okamu1002@gmail.com
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Okamura |
Organization
Nagasaki Harbor Medical Center
Division name
Gastroenterology
Zip code
850-8555
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
TEL
0958223251
Homepage URL
taku.okamu1002@gmail.com
Sponsor or person
Institute
Nagasaki Harbor Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagasaki Harbor Medical Center
Address
6-39 Shinchi-machi, Nagasaki-shi, Nagasaki
Tel
0958223251
kenkyu@ncho.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 | 02 | Month | 27 | 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
172
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
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Significant differences in each endpoint were analyzed among the three independent groups no traction, single-point traction, and multipoint traction. Among the endpoints, resection speed, resection time, and local injection drug use were proportionally scaled, and the Shapiro-Wilk test and the Kruskal-Wallis test were used to test normality and analysis of variance, respectively, for the three groups. The Bonferroni method was used for multiple comparisons for all endpoints. The p-values were tested at the two sided 5% significance level against the null hypothesis. There is no difference between the compared groups.
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065342
