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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041244
Receipt No. R000046811
Scientific Title A randomized controlled trial comparing conventional ESD versus hybrid ESD for gastric neoplasms
Date of disclosure of the study information 2020/07/29
Last modified on 2020/08/09

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Basic information
Public title A randomized controlled trial comparing conventional ESD versus hybrid ESD for gastric neoplasms
Acronym Hybrid-G study
Scientific Title A randomized controlled trial comparing conventional ESD versus hybrid ESD for gastric neoplasms
Scientific Title:Acronym A randomized controlled trial comparing conventional ESD versus hybrid ESD for gastric neoplasms
Region
Japan

Condition
Condition Gastric neoplasm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study investigates the usefulness of snaring during dissection in ESD for gastric neoplasms.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Procedure time of ESD
Key secondary outcomes Time and speed of mucosal incision
Time and speed of submucosal dissection with or without snaring
En bloc and complete resection
Curability judged by histological assessment of resected specimen
Endoscopic procedural adverse events including intraoperative perforation, delayed perforation and delayed bleeding
Degree of dissected submucosal layer before snaring
Volume of injective solution
Number and time of hemostasis using hemostatic device during procedure
Thickness of submucosal layer in resected specimen
The relationship between outcomes and morphology / location / size/ ulceration / operator's experience.

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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 When assigned to the standard treatment group (group A), conventional ESD is performed.
Interventions/Control_2 When assigned to the study treatment group (group B), hybrid ESD is performed.
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 -Male or female aged 20 years with early gastric neoplasm who will undergo endoscopic resection as a local treatment
-Eligible lesion is diagnosed as a gastric adenoma or adenocarcinoma by endoscopic biopsy within 90 days before enrollment.
-Eligible lesion is endoscopically diagnosed as a mucosal lesion within 20 mm in diameter without ulceration.
-Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of each eligible patient is 0, 1, or 2.
-Eligible patients will be asked to listen to oral explanation and read explanatory documents providing doctors' instruction and sign consent forms. Informed consent will be obtained from each eligible patient before enrollment in the trial
-Stated willingness to comply with all study procedures and availability for the duration of the study
Key exclusion criteria -Patients with a history of gastric surgery
-Patients on dialysis
-Patients requiring continuous administration of heparin during perioperative period.
-Contraindication with endoscopy; ileus, gastrointestinal perforation or severe respiratory/cardiac disease.
-Metal allergy
-Patients who are judged inappropriate by physician participating in this trial
-Patients who cannot obtain informed consent
Target sample size 82

Research contact person
Name of lead principal investigator
1st name Haruei
Middle name
Last name Ogino
Organization Graduate School of Medicine, Kyushu University
Division name Department of Medicine and Bioregulatory Science
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5286
Email ogino@intmed3.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Esaki
Organization Graduate School of Medicine, Kyushu University
Division name Department of Medicine and Bioregulatory Science
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5286
Homepage URL
Email esaki_saiseikai@yahoo.co.jp

Sponsor
Institute Graduate School of Medicine, Kyushu University
Institute
Department

Funding Source
Organization Graduate School of Medicine, 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 Kyushu University Institutional Review Board for Clinical Trials
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel 092-642-5082
Email byskenkyu@jimu.kyushu-u.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 九州大学病院(福岡県)、九州医療センター(福岡県)、福岡東医療センター(福岡県)、原三信病院(福岡県)、福岡市民病院(福岡県)、済生会二日市病院(福岡県)、福岡中央病院(福岡県)、済生会八幡病院(福岡県)、別府医療センター(大分県)

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 29 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
2020 Year 07 Month 28 Day
Date of IRB
2020 Year 07 Month 28 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2022 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
2020 Year 07 Month 29 Day
Last modified on
2020 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046811

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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