UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050684 |
|---|---|
| Receipt number | R000057664 |
| Scientific Title | Evaluation of the efficacy of motorized spiral enteroscope in colorectal endoscopic submucosal dissection (ESD) in cases with difficulty of intubation or poor maneuverability |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/03/27 11:45:53 |
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Basic information
Public title
Evaluation of the efficacy of motorized spiral enteroscope in colorectal endoscopic submucosal dissection (ESD) in cases with difficulty of intubation or poor maneuverability
Acronym
Evaluation of the efficacy of motorized spiral enteroscope in colorectal endoscopic submucosal dissection (ESD) in cases with difficulty of intubation or poor maneuverability
Scientific Title
Evaluation of the efficacy of motorized spiral enteroscope in colorectal endoscopic submucosal dissection (ESD) in cases with difficulty of intubation or poor maneuverability
Scientific Title:Acronym
Evaluation of the efficacy of motorized spiral enteroscope in colorectal endoscopic submucosal dissection (ESD) in cases with difficulty of intubation or poor maneuverability
Region
| Japan |
Condition
Condition
Early stage colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of motorized spiral enteroscope in colorectal endoscopic submucosal dissection (ESD) for cases with difficulty of intubation or poor maneuverability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of endoscopic submucosal dissection (ESD)
Key secondary outcomes
En bloc resection rate
R0 resection rate
Procedure time
Lesion size
Specimen size
Adverse event rate (perforation, delayed 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 20 years of age or older scheduled for colonoscopic endoscopic submucosal dissection (ESD) with difficulty of intubation or poor maneuverability
Key exclusion criteria
(1)Lesions on scars after endoscopic treatment
(2)Patients with a high degree of intestinal adhesions expected, such as a history of abdominal laparotomy
(3)Patients who are unable to stop antithrombotic drugs according to the guidelines
(4)Patients with abnormal blood coagulation function
(5)Patients with critical organ failure
(6)Other cases judged as inappropriate by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
160-8582
Address
35 shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3437
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Kurato |
| Middle name | |
| Last name | Miyazaki |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3437
Homepage URL
k.miyazaki30417@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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 | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To perform colorectal ESD using motorized spiral enteroscope for cases with difficulty of intubation or poor maneuverability, and to review the outcomes of ESD.
Management information
Registered date
| 2023 | Year | 03 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057664
