UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034970 |
|---|---|
| Receipt number | R000039874 |
| Scientific Title | Prospective study on the effectiveness and safety of endoscopic resection using Souten snare in gastric tumors |
| Date of disclosure of the study information | 2018/11/21 |
| Last modified on | 2022/12/12 19:57:55 |
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Basic information
Public title
Prospective study on the effectiveness and safety of endoscopic resection using Souten snare in gastric tumors
Acronym
Efficacy of endoscopic resection using Souten snare in stomach tumor
Scientific Title
Prospective study on the effectiveness and safety of endoscopic resection using Souten snare in gastric tumors
Scientific Title:Acronym
Efficacy of endoscopic resection using Souten snare in stomach tumor
Region
| Japan |
Condition
Condition
gastric tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess the efficacy and safety of Souten snare in hybrid ESD of gastric tumor prospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
procedure time, histological complete resection rate, curative resection rate, perforation rate, bleeding rate
Key secondary outcomes
required medical expenses
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Differentiated mucosal carcinoma without ulcer at 15mm or less
Key exclusion criteria
Lesions for which surgical resection is desired by preoperative diagnosis
Patients who were judged not eligible for participation in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Taiga |
| Middle name | |
| Last name | Chiyo |
Organization
Kagawa University, Faculty of Medicine
Division name
Department of Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL
0878912156
chiyo.taiga@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Taiga |
| Middle name | |
| Last name | Chiyo |
Organization
Kagawa university
Division name
Department of Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL
0878912156
Homepage URL
chiyo.taiga@kagawa-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Japan
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa university
Address
kita-gun miki-cho ikenobe
Tel
0878912156
chiyo.taiga@kagawa-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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 21 | 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
57
Results
The curative resection rate of h-ESD was 89.5% (51/57). The total (h-ESD + ESD) curative resection rate was 94.7% (54/57). The mean procedure time was 21.2 (+/-16.5) minutes. One case of delayed bleeding occurred. Additional knives were applied in two cases.
Results date posted
| 2022 | Year | 12 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
The primary endpoint was curative resection rate of h-ESD. A difficult snaring case due to unexpected poor submucosal lifting was rescued by conventional ESD (conversion to ESD rate). Secondary endpoints included procedure time, total (h-ESD + ESD) curative resection rate, use rate of knives other than a SOUTEN (excluding hemostats), intraoperative and postoperative perforation rate, intraoperative bleeding, and postoperative bleeding.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 29 | 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
none
Management information
Registered date
| 2018 | Year | 11 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039874
