UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047922 |
|---|---|
| Receipt number | R000054631 |
| Scientific Title | A retrospective cohort study comparing an S-O clip and a clip-with-line traction method of endoscopic submucosal dissection for gastric epithelial neoplasia |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2024/12/02 19:02:03 |
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Basic information
Public title
A retrospective cohort study comparing an S-O clip and a clip-with-line traction method of endoscopic submucosal dissection for gastric epithelial neoplasia
Acronym
A retrospective cohort study comparing an S-O clip and a clip-with-line traction method of endoscopic submucosal dissection for gastric epithelial neoplasia
Scientific Title
A retrospective cohort study comparing an S-O clip and a clip-with-line traction method of endoscopic submucosal dissection for gastric epithelial neoplasia
Scientific Title:Acronym
A retrospective cohort study comparing an S-O clip and a clip-with-line traction method of endoscopic submucosal dissection for gastric epithelial neoplasia
Region
| Japan |
Condition
Condition
early gastric cancers, gastric adenomas
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparing the ESD procedure-related effects of an S-O clip and a clip-with-line in the traction-assisted gastric ESD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastric ESD procedure time
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 94 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Preoperative endoscopy diagnosed or suspected to be gastric adenoma or cancer that meets the absolute or expanded indication of ESD according to the Japanese guidelines for ESD and EMR for early gastric cancer (second edition)
2) Patients who underwent S-O clip-assisted ESD or clip-with-line-assisted ESD
3) Written informed consent by patients for ESD
Key exclusion criteria
1) Patients who underwent gastrectomy or reconstructive surgery of gastric tube
2) Lesions that were suspected of superficial gastric neoplasms preoperatively but diagnosed as a non-neoplastic lesions by the pathological examination after ESD
3) Other than the first treated lesion in patients who underwent ESD for two or more lesions at one time
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Nagata |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Department of Endoscopy
Zip code
253-0041
Address
1-5-1 TUJIDOUKANDAI FUJISAWA KANAGAWA JAPAN
TEL
0466-35-1177
mitsuru10jp@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Nagata |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Department of Endoscopy
Zip code
253-0041
Address
1-5-1 TUJIDOUKANDAI FUJISAWA KANAGAWA JAPAN
TEL
0466-35-1177
Homepage URL
mitsuru10jp@yahoo.co.jp
Sponsor or person
Institute
Shonan Fujisawa Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Fujisawa Tokushukai Hospital
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
Mirai Iryo Research Center
Address
1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel
03-3263-4801
shimizu@mirai-iryo.com
Secondary IDs
Secondary IDs
YES
Study ID_1
TGE01799-008
Org. issuing International ID_1
Mirai Iryo Research Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
湘南藤沢徳洲会病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s10620-023-07870-z
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s10620-023-07870-z
Number of participants that the trial has enrolled
140
Results
Propensity score matching created 42 pairs. The median gastric ESD procedure time in the SLC-ESD group was significantly shorter than that in the CWL-ESD group (28.3 min vs. 51.0 min, P = 0.022). All traction direction in the SLC-ESD group was vertical, while only 16.7% in the CWL-ESD group. En bloc resection was attained without perforation in all the patients in both groups.
Results date posted
| 2024 | Year | 12 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No significant differences were observed in matching factors (lesion size, injection function of electrosurgical knife, ulcerative lesion, lesion location, and lesion position), specimen size, and specimen area between the two groups.
Participant flow
One hundred forty patients with superficial gastric neoplasms who underwent SLC-ESD or CWLESD by a single ESD expert between November 2017 and September 2020 were retrospectively enrolled. Propensity score matching created 42 pairs.
Adverse events
Post-ESD bleeding occurred in the SLC-ESD group.
Outcome measures
The primary outcome: gastric ESD procedure time.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From November 2017 to September 2020, among the cases in which gastric ESD was performed at the department of endoscopic in Shonan Fujisawa Tokushukai Hospital, the cases that met the selection exclusion criteria were included in the study.
Management information
Registered date
| 2022 | Year | 06 | Month | 01 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054631
