UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054516 |
|---|---|
| Receipt number | R000062278 |
| Scientific Title | A multicenter retrospective study of influential factors on stricture after moderate resection of circumference in Esophageal endoscopic submucosal dissection. |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2026/01/19 20:53:11 |
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Basic information
Public title
A multicenter retrospective study of influential factors on stricture after moderate resection of circumference in Esophageal endoscopic submucosal dissection.
Acronym
A multicenter retrospective study of influential factors on stricture after moderate resection of circumference in Esophageal endoscopic submucosal dissection.
Scientific Title
A multicenter retrospective study of influential factors on stricture after moderate resection of circumference in Esophageal endoscopic submucosal dissection.
Scientific Title:Acronym
A multicenter retrospective study of influential factors on stricture after moderate resection of circumference in Esophageal endoscopic submucosal dissection.
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze and study factors affecting postoperative stenosis and symptoms of stenosis in patients with circumferential circumference of 50% to less than 75% resection in esophageal endoscopic submucosal dissection (ESD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors in appearance of stenosis and symptoms of stenosis after esophageal ESD.
Key secondary outcomes
To evaluate (1) stenosis rate, (2) stenosis symptom occurrence rate, and (3) adverse events other than stenosis-related events (postoperative bleeding, delayed perforation, etc.) in the steroid use/non-use group.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients who underwent esophageal ESD at participating institutions and whose endoscopically observed circumferential mucosal defect was between 50% and 75% immediately after esophageal ESD
2. patients aged 20 years or older at the time of esophageal ESD
Key exclusion criteria
1. esophageal ESD performed on multiple esophageal lesions at the same time and multiple mucosal defects with a circumference of 50% or more on endoscopic visualization
2. cases with intraoperative perforation
2. cases of intraoperative perforation
3. patients who received steroids before the surgery
4. patients with a history of esophageal stricture not caused by esophageal ESD
5. patients who refused to participate in this study.
6. other patients whom the principal investigator or research assistant judged to be inappropriate to participate in this study.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Goto |
Organization
Nippon Medical School, Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
o-goto@nms.ac.jp
Public contact
Name of contact person
| 1st name | Tsugumi |
| Middle name | |
| Last name | Habu |
Organization
Nippon Medical School, Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
t-habu@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
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
Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
t-habu@nms.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 | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
513
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 | 05 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 08 | Month | 30 | Day |
Other
Other related information
The database analysis was then performed between April 2018 to March 2022.
Management information
Registered date
| 2024 | Year | 05 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062278
