UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047475 |
|---|---|
| Receipt number | R000054084 |
| Scientific Title | A multicenter prospective randomized controlled trial of the usefulness of RDI for injection in esophageal ESD |
| Date of disclosure of the study information | 2022/04/14 |
| Last modified on | 2023/10/15 21:41:05 |
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Basic information
Public title
A multicenter prospective randomized controlled trial of the usefulness of RDI for injection in esophageal ESD
Acronym
Esophageal RDI study
Scientific Title
A multicenter prospective randomized controlled trial of the usefulness of RDI for injection in esophageal ESD
Scientific Title:Acronym
Esophageal RDI study
Region
| Japan |
Condition
Condition
superficial esophageal cancer
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether using RDI to identify deep blood vessels and avoiding them during injection for esophageal ESD can prevent bleeding and hematoma formation associated with injection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major bleeding or not
Key secondary outcomes
1. The number of blood vessels observed around the lesion
2. Frequency of major/minor bleeding associated with injection
3. The number of hematomas per unit length of the mucosal resection line
4. Procedure time
5. En-block resection rate
6. R0 resection rate
7. Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
During mucosal injection in esophageal ESD, use RDI to identify the presence of blood vessels and avoid them during injection.
Interventions/Control_2
During mucosal injection in esophageal ESD, white light alone is used for injection without RDI.
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
Patients over 20 years old who will undergo ESD for lesions diagnosed or suspected to be superficial esophageal cancer at Keio University Hospital and collaborating hospitals. We don't necessarily need a tissue diagnosis.
Key exclusion criteria
(1) Cases in which antithrombotic drug withdrawal is not feasible according to guidelines (Guidelines for Gastrointestinal Endoscopy for Patients on Antithrombotic Medications)
(2) Lesions less than 5 mm or more than 50 mm in size at the time of preoperative evaluation.
(3) Cases in which a histological type other than squamous cell carcinoma, such as Barrett's adenocarcinoma, is suspected.
(4) Cases of esophagogastric junction carcinoma in which the resection line does not settle within the squamous epithelium
(5) Cases in which the resection is full circumferential
(6) Cases after surgical treatment
(7) Cases involving scars after endoscopic treatment
(8) Cases involving radiotherapy irradiation areas
(9) Patients with coagulation disorders
(10) Patients on continuous hemodialysis
(11) Patients with non-compensated liver cirrhosis
(12) Cases that investigators consider inappropriate to conduct this study
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Cancer center
Division name
Division of research and development for minimally invasive treatment
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Kurato |
| Middle name | |
| Last name | Miyazaki |
Organization
Cancer center
Division name
Division of research and development for minimally invasive treatment
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
k.miyazaki30417@gmail.com
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
1. National Hospital Organization Tokyo Medical Center
2. Saitama City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Hospital
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054084
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