UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051238 |
|---|---|
| Receipt number | R000058433 |
| Scientific Title | Outcomes of underwater endoscopic mucosal resection (UEMR) for neoplastic lesions on or near the scar |
| Date of disclosure of the study information | 2023/06/02 |
| Last modified on | 2023/06/02 10:25:19 |
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Basic information
Public title
Outcomes of underwater endoscopic mucosal resection (UEMR) for neoplastic lesions on or near the scar
Acronym
UEMR for scar lesion
Scientific Title
Outcomes of underwater endoscopic mucosal resection (UEMR) for neoplastic lesions on or near the scar
Scientific Title:Acronym
UEMR for scar lesion
Region
| Japan |
Condition
Condition
Tumors of the duodenum or colon
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate the outcomes of underwater endoscopic mucosal resection (UEMR) for residual lesions after endoscopic treatment of the duodenum and colon, benign ulcer scars, and neoplastic lesions at or near post-surgical scars and anastomoses, and to evaluate its utility.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of residual or local recurrence in follow-up endoscopy
Key secondary outcomes
Complete resection rate
Association of endoscopic resection results with disease or treatment factors
Association of endoscopic resection or pathology results with local recurrence
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Neoplastic lesions of 2 cm or less in the duodenum and colon that meet either 1) or 2) and are expected to be difficult to resect due to severe fibrosis.
1) Residual or locally recurrent lesions after endoscopic treatment
2) Neoplastic lesions found at or near (within 1 cm) the site of a scar, such as a scar after endoscopic treatment, benign ulcer scar, or scar or anastomosis after surgical procedure
Key exclusion criteria
Patients with severe cardiopulmonary diseases.
Patients whose enrollment or participation in this study seem difficult due to concomitant psychiatric disorders.
Other patients that the physician judges inappropriate for the safe conduct of this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
+81--6-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Tsujii |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
+81--6-6879-3621
Homepage URL
yoshikitsujii1977@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
Osaka University Hospital
Address
2-2 Yamadaoka, Suita, Osaka, Japan
Tel
+81-6-6210-8296
rinri@hp-crc.med.osaka-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
| 2023 | Year | 06 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Study Design>
Multicenter prospective observational study
<Treatment Schedule>
Treatment will be administered after explaining the study to eligible patients and obtaining consent forms and enrolling patients who agree to participate in the study.
At the time of treatment, the lesions will be thoroughly observed and evaluated prior to resection, and the lesions will be resected by UEMR.
Post-treatment pathology results will then be collected.
Follow-up endoscopy is performed 2-15 months after UEMR to check for residual or recurrent disease at the resection site.
Management information
Registered date
| 2023 | Year | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058433
