UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034765 |
|---|---|
| Receipt number | R000039648 |
| Scientific Title | Clinical study on colonic endoscopic submucosal dissection using Endosaber |
| Date of disclosure of the study information | 2019/11/05 |
| Last modified on | 2022/05/09 14:21:06 |
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Basic information
Public title
Clinical study on colonic endoscopic submucosal dissection using Endosaber
Acronym
Clinical study on colonic ESD using Endosaber
Scientific Title
Clinical study on colonic endoscopic submucosal dissection using Endosaber
Scientific Title:Acronym
Clinical study on colonic ESD using Endosaber
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical outcomes of endoscopic submucosal dissection with self-completion method using Endosaber for colorectal neoplasms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-completion ESD rate without any other devices and assistance
Key secondary outcomes
Procedure time, en-bloc/complete resection rate, complication rate, pathological ecvaluation
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Leions diagnosed as adenoma or adenocarcinoma by endoscopy/biopsy
Lesions within 4cm
Lesions not on the cecum
Lesions not on the folds
Lesions without submucosal ficrosis
Lesions without lymph node or distant metastasis
Patient's PS: 0 or 1
Maintained main organs function
Without dialysis
Written informed consent
Key exclusion criteria
Patient's refusal
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Esaki |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
173-8610
Address
30-1, Oyaguchikami-cho Itabashi-ku, Tokyo
TEL
03-3293-8111
esaki_saiseikai@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Esaki |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
173-8610
Address
30-1, Oyaguchikami-cho Itabashi-ku, Tokyo
TEL
03-3293-8111
Homepage URL
esaki_saiseikai@yahoo.co.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
20,20
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine
Address
30-1, Oyaguchikami-cho Itabashi-ku, Tokyo
Tel
0339728111
esaki_saiseikai@yahoo.co.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
| 2019 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
In submission
Publication of results
Unpublished
Result
URL related to results and publications
In submission
Number of participants that the trial has enrolled
15
Results
In total, 15 patients with 15 lesions were enrolled. The median size of the resected lesions was 28 mm. All performed procedures were completed, and an SESD success rate of 100% was achieved. The median procedure time was 44 minutes. En bloc, complete, and curative resection rates of 100%, 93.3%, and 86.7%, respectively, and a complication rate of 6.7% (perforation: 0%, delayed bleeding: 6.7%).
Results date posted
| 2021 | Year | 05 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In total, 15 patients with 15 lesions were enrolled. The median size of the resected lesions was 28 mm.
Participant flow
All performed procedures were completed.
Adverse events
A complication rate of 6.7% (perforation: 0%, delayed bleeding: 6.7%).
Outcome measures
SESD success rate of 100% was achieved.
The median procedure time was 44 minutes. En bloc, complete, and curative resection rates of 100%, 93.3%, and 86.7%, respectively, and a complication rate of 6.7% (perforation: 0%, delayed bleeding: 6.7%).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
ESD with self-completion method using Endosaber will be an important option if good outcomes are obtained.
Management information
Registered date
| 2018 | Year | 11 | Month | 05 | Day |
Last modified on
| 2022 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039648
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