UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047353 |
|---|---|
| Receipt number | R000054009 |
| Scientific Title | A randomized controlled trial comparing conventional ESD versus Spray-ESD for gastric neoplasms: A multi-center trial (Spray-G Trial) |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/04/03 08:14:30 |
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Basic information
Public title
A randomized controlled trial comparing conventional ESD versus Spray-ESD for gastric neoplasms: A multi-center trial (Spray-G Trial)
Acronym
Spray-G Trial
Scientific Title
A randomized controlled trial comparing conventional ESD versus Spray-ESD for gastric neoplasms: A multi-center trial (Spray-G Trial)
Scientific Title:Acronym
Spray-G Trial
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of Spray mode in ESD for gastric neoplasms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion of ESD with endo-knife alone
Key secondary outcomes
Number of hemostasis, time of hemostasis, treatment time (total, mucosal incision, submucosal dissection), dissection speed, en bloc resection, complete resection, curative resection (degree of each endoscopic cure), thickness and thermal degeneration of submucosal layer in resected specimen, type and volume of submucosal injective solution used, operator change, traction use, complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional ESD(ESD with Forced Coagulation Mode)
Interventions/Control_2
Spray-ESD (ESD with Spray Coagulation Mode)
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
(1)Presence of EGN diagnosed by endoscopy and capable of undergoing ESD as a local treatment
(2)Lesions diagnosed by endoscopic biopsy as gastric adenomas or adenocarcinomas
(3)20 years old or more
(4)Performance Status: 0, 1, 2
(5)Informed consent is obtained
Key exclusion criteria
(1)History of gastric surgery
(2)Currently undergoing dialysis
(3)Requiring continuous administration of heparin during the perioperative period.
(4)Those with contraindications for endoscopy
(5)Patients judged to be inappropriate for the study by the attending physician in this trial
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yorinobu |
| Middle name | |
| Last name | Sumida |
Organization
Kitakyushu Municipal Medical Center
Division name
Department of Gastroenterology
Zip code
802-8561
Address
2-1-1, Bashaku, Kokura-kitaku, Kitakyushu
TEL
093-541-1831
y.raisin@gmail.com
Public contact
Name of contact person
| 1st name | Yorinobu |
| Middle name | |
| Last name | Sumida |
Organization
Kitakyushu Municipal Medical Center
Division name
Department of Gastroenterology
Zip code
802-8561
Address
2-1-1, Bashaku, Kokura-kitaku, Kitakyushu
TEL
093-541-1831
Homepage URL
y.raisin@gmail.com
Sponsor or person
Institute
Kitakyushu Municipal Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kyushu 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
IRB of Kitakyushu City Hospita Organization
Address
1-35, Kofunabemachi, Kokurakita-ku, Kitakyushu City
Tel
093-533-5615
kcho-kenkyu01@kitakyu-cho.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 | 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
130
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2024 | 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 | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054009
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
