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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046632
Receipt No. 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 2022/01/14

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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
Email 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
Email marimizutani6@keio.jp

Sponsor
Institute Keio University
Institute
Department

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
Email 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
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
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
2022 Year 01 Month 14 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
2022 Year 01 Month 14 Day


Link to view the page
URL(English) 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


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