UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048671 |
|---|---|
| Receipt number | R000055458 |
| Scientific Title | The efficacy of an endoscopic continuous aspiration catheter in maintaining the permeability of the operative field and preventing excessive water injection in colorectal submucosal dissection using the water pressure method: A prospective observational study |
| Date of disclosure of the study information | 2022/08/16 |
| Last modified on | 2024/02/15 12:24:39 |
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Basic information
Public title
The efficacy of an endoscopic continuous aspiration catheter in maintaining the permeability of the operative field and preventing excessive water injection in colorectal submucosal dissection using the water pressure method: A prospective observational study
Acronym
The efficacy of an endoscopic continuous aspiration catheter in maintaining the permeability of the operative field and preventing excessive water injection in colorectal submucosal dissection using the water pressure method: A prospective observational study
Scientific Title
The efficacy of an endoscopic continuous aspiration catheter in maintaining the permeability of the operative field and preventing excessive water injection in colorectal submucosal dissection using the water pressure method: A prospective observational study
Scientific Title:Acronym
The efficacy of an endoscopic continuous aspiration catheter in maintaining the permeability of the operative field and preventing excessive water injection in colorectal submucosal dissection using the water pressure method: A prospective observational study
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of endoscopic continuous aspiration catheters in maintaining the permeability of the surgical field and preventing excessive water injection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aspiration volume by continuous aspiration catheter and mass of sediment extracted from endoscopically collected intestinal fluid over time.
Key secondary outcomes
Clinical characteristics of the lesion (loation, size, gross type)
Degree of bowel cleaning
Treatment outcomes (resection time, en bloc resection, R0 resection, pathology, adverse event)
Endoscopic aspiration and water injection volume
Fluid leakage from the anus
Effect of a continuous aspiration catheter on operability
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
A case of colorectal submucosal dissection in which the water pressure method is planned to be used throughout the procedure
Key exclusion criteria
Cases in which multiple lesions are scheduled to be resected at the same time.
Cases in which the patient is incapable of consent due to a minor, dementia, etc.
Other cases that the physician in charge deems inappropriate for registration.
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
Cancer center, division of research and development for minimal invasive treatment
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | masunaga |
Organization
Keio University, school of medicine
Division name
Cancer center, division of research and development for minimal invasive treatment
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
teppei9027ww@keio.jp
Sponsor or person
Institute
Keio 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
Keio University, school of medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
keio-ctr-coijim@adst.keio.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
| 2022 | Year | 08 | Month | 16 | 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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective observational study
Aim: To evaluate the efficacy of an endoscopic continuous aspiration catheter in maintaining the permeability of the surgical field and preventing excessive water injection.
Management information
Registered date
| 2022 | Year | 08 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055458
