UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041244 |
|---|---|
| Receipt number | 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 | 2024/04/03 08:22:13 |
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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
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
esaki_saiseikai@yahoo.co.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyushu University
Institute
Department
Personal name
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
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
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06099-x
Publication of results
Published
Result
URL related to results and publications
https://www.cghjournal.org/article/S1542-3565(22)01019-9/fulltext
Number of participants that the trial has enrolled
82
Results
The procedure time of H-ESD was significantly shorter than that of C-ESD (33.16 min vs 62.46 min; H-ESD/C-ESD ratio: 0.53; 95% confidence interval, 0.41-0.69; P < .0001).
Results date posted
| 2024 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thare was no significant difference between two groups.
Participant flow
A total of 39 and 40 patients underwent H-ESD and C-ESD, respectively.
Adverse events
No difference was observed between the 2 groups.
Outcome measures
The procedure time of H-ESD was significantly shorter than that of C-ESD (33.16 min vs 62.46 min; H-ESD/C-ESD ratio: 0.53; 95% confidence interval, 0.41-0.69; P < .0001). There was no significant difference in mucosal incision time between the 2 groups; the time and speed of submucosal dissection of H-ESD were significantly shorter than those of C-ESD. No difference was observed between the 2 groups in other outcomes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 08 | Month | 27 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 29 | 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=R000046811
