UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046632 |
|---|---|
| Receipt number | R000053197 |
| Scientific Title | A Study of Esophageal ESD Using Water Pressure Method with continuous suction |
| Date of disclosure of the study information | 2022/01/14 |
| Last modified on | 2023/08/01 22:42:01 |
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Basic information
Public title
Water pressure method in Esophageal ESD study
Acronym
WEE study
Scientific Title
A Study of Esophageal ESD Using Water Pressure Method with continuous suction
Scientific Title:Acronym
WEE study
Region
| Japan |
Condition
Condition
Epithelial esophageal cancer, esophagogastric junction cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To unveil the usefulness and safety of esophageal ESD using the water pressure method with continuous suction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of endoscopic ESD completed with the water pressure method
Key secondary outcomes
1) Enblock resection rate
2) R0 resection rate
3) Resection time
4) Incidental disease rate (pneumonia, intraoperative perforation, delayed perforation, bleeding)
5) Hospitalization period
6) Number of intraoperative hypoxia (SpO2 less than 85)
7) Volume of water injected and suctioned
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
The cases in which esophageal ESD will be performed at the relevant facilities after January 2022, cases with incisors deeper than 25 cm
Key exclusion criteria
1) Cervical and upper esophageal cases
2) Patients with severe respiratory failure (on home oxygen, severe asthma, etc.)
3) Cases of systemic administration of immunosuppressive drugs (not including topical drugs)
4) Post esophageal CRT, post ESD scar, post surgical cases
5) Patients refusing KEIO-GI
6) Patients under general anesthesia
7) Other cases judged by the physician in charge to be unsuitable 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
Division name
Division of Gastroenterology & Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Mizutani |
Organization
Keio University
Division name
Division of Gastroenterology & Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
marimizutani6@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
no
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
Keio University
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@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
慶應義塾大学病院(東京都),さいたま市立病院(埼玉県), 東京医療センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 14 | 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
9
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
Terminated
Date of protocol fixation
| 2022 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the efficacy and safety of esophageal ESD using a continuous suction tube in combination with the water pressure method.
Management information
Registered date
| 2022 | Year | 01 | Month | 14 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053197
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
