UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056387 |
|---|---|
| Receipt number | R000064423 |
| Scientific Title | Usefulness of the bridge formation method for colorectal endoscopic submucosal dissection: a propensity score-matched study |
| Date of disclosure of the study information | 2024/12/10 |
| Last modified on | 2024/12/07 11:52:22 |
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Basic information
Public title
Usefulness of the bridge formation method for colorectal endoscopic submucosal dissection: a propensity score-matched study
Acronym
Usefulness of the bridge formation method for colorectal endoscopic submucosal dissection: a propensity score-matched study
Scientific Title
Usefulness of the bridge formation method for colorectal endoscopic submucosal dissection: a propensity score-matched study
Scientific Title:Acronym
Usefulness of the bridge formation method for colorectal endoscopic submucosal dissection: a propensity score-matched study
Region
| Japan |
Condition
Condition
colon neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic submucosal dissection (ESD) has enabled endoscopic resection of all early-stage cancers, regardless of the size of the colorectal tumor. However, a high rate of complications remains a problem. Perforation, a serious intraoperative incident, occurs in an average of 5% of cases and exceeds 10% in beginners, and there is still no solution to this problem, which depends on the skill of the surgeon (Saito Y, et al. Gastrointestinal Endosc 2010). In order to reduce the number of accidents, we searched for a safer and more stable treatment method, and came up with a new treatment technique, the Bridge Formation Method. A retrospective comparison of outcomes was conducted to determine whether the technique was effective in practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This retrospective study included consecutive patients with 2647 colorectal lesions resected by ESD from September 2003 to December 2023. The main outcome measure was comparison of the en bloc resection rate.
Key secondary outcomes
The secondary outcome measure were R0 resection rate, Average dissection speed, Treatment time, Perforation rate and Post-bleeding rate.
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
| 24 | years-old | <= |
Age-upper limit
| 93 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consecutive patients treated during this period were analyzed.
Key exclusion criteria
Excluding advanced cancer, neuroendocrine tumors, and colitis associated neoplasia.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Abe |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive disease center
Zip code
2248503
Address
35-1, Chigasaki-chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
0459497000
masahiro.abe@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Abe |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive disease center
Zip code
2248503
Address
35-1, Chigasaki-chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
0459497000
Homepage URL
masahiro.abe@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Masahiro Abe
Funding Source
Organization
none
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
Showa University Northern Yokohama Hospital
Address
35-1, Chigasaki-chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
Tel
0459497000
masahiro.abe@med.showa-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
| 2024 | Year | 12 | Month | 10 | 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
2647
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
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively reviewed the patients medical records and enrolled their medical history, endoscopic findings, and pathologic findings in the database.
Management information
Registered date
| 2024 | Year | 12 | Month | 07 | Day |
Last modified on
| 2024 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064423
