UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032713 |
|---|---|
| Receipt number | R000037303 |
| Scientific Title | Endoscopic submucosal dissection for neoplasia of the greater curvature of the upper and middle stomach: J-shaped superficial cutting and splashed dissection |
| Date of disclosure of the study information | 2018/06/07 |
| Last modified on | 2018/06/07 23:08:41 |
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Basic information
Public title
Endoscopic submucosal dissection for neoplasia of the greater curvature of the upper and middle stomach: J-shaped superficial cutting and splashed dissection
Acronym
Strategy of ESD for gastric cancer at great curvature
Scientific Title
Endoscopic submucosal dissection for neoplasia of the greater curvature of the upper and middle stomach: J-shaped superficial cutting and splashed dissection
Scientific Title:Acronym
Strategy of ESD for gastric cancer at great curvature
Region
| Japan |
Condition
Condition
Early Gastric cancer,adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of the J-shaped superficial cutting and splashed submucosal dissection (JSCS) technique for neoplasia of the greater curvature by comparing ESD using JSCS with conventional ESD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome was the en bloc resection rate.
Key secondary outcomes
Secondary outcomes included complete resection (R0) rate, procedure time, perforation rate, total bleeding time, and the total number massive bleeding events and number of times hemostatic forceps were used during ESD.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Gastric neoplasia included early gastric cancer and adenoma that could not be preoperatively distinguished from early gastric cancer. ESD was indicated for early gastric cancer in which the invasion depth was expected to be less than slightly submucosal and there was no possible lymph node metastasis, based on Japanese ESD criteria. The inclusion criterion was a lesion affecting the greater curvature of the upper and middle body of the stomach.
Key exclusion criteria
The patient who does not agree with this study.And the cancer suitable for surgery rather than ESD by following EGD,and UL positive.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Nishiyama |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Gastroenterology
Zip code
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
087-891-2156
n-nori@med.kagawa-ua.c.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Nishiyama |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Gastroenterology
Zip code
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
087-891-2156
Homepage URL
n-nori@med.kagawa-ua.c.jp
Sponsor or person
Institute
Faculty of Medicine, Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, Kagawa University
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
Address
Tel
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 | 06 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2008 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 25 | Day |
Last follow-up date
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 | 05 | Month | 24 | Day |
Last modified on
| 2018 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037303
