UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022820 |
|---|---|
| Receipt number | R000026017 |
| Scientific Title | Procedure time for gastric endoscopic submucosal dissection according to location, considering both sides of the mucosal circumferential incision and submucosal dissection ; retrospective study |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2016/06/21 14:50:02 |
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Basic information
Public title
Procedure time for gastric endoscopic submucosal dissection according to location, considering both sides of the mucosal circumferential incision and submucosal dissection ; retrospective study
Acronym
Procedure time for gastric endoscopic submucosal dissection according to location, considering both sides of the mucosal circumferential incision and submucosal dissection
Scientific Title
Procedure time for gastric endoscopic submucosal dissection according to location, considering both sides of the mucosal circumferential incision and submucosal dissection ; retrospective study
Scientific Title:Acronym
Procedure time for gastric endoscopic submucosal dissection according to location, considering both sides of the mucosal circumferential incision and submucosal dissection
Region
| Japan |
Condition
Condition
gastric neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The difficulty and procedure time of gastric endoscopic submucosal dissection (ESD) has only been superficially examined with the stomach divided into three areas, namely, the upper, middle, and lower areas. However, there are two important phases that define the procedure time for ESD, the mucosal circumference incision speed (CIS) and submucosal dissection speed (SDS). Furthermore, depending on the situation, various problems can arise from the specific area, which must be clarified during treatment by operators with various skill levels. Thus, we aimed to clarify all the situations that are considered to be different and make a new classification system for procedure time.
Basic objectives2
Others
Basic objectives -Others
Objective fact
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference between the mucosal circumference incision speed of every 12 location of the stomach
The difference between the submucosal dissection speed of every 12 location of the stomach
Key secondary outcomes
Clinicopathological features of every 12 location of the lesion
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We examined all cases in the databases of the undifferentiated mixed type gastric cancer indicated for ESD according to the Japanese guidelines from April 1, 2009 to July 31, 2014
Key exclusion criteria
The first two cases of operators who recently met the criteria during the observation period were excluded. Finally, to include curative en bloc and R0 resection cases only for the study, piecemeal resection, discontinuation, and non-curative resection cases were also excluded
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironori Konuma |
Organization
Juntendo Nerima Hospital
Division name
Gastroenterology
Zip code
Address
3-1-10 Takanodai, Nerima-ku, Tokyo 177-8521, Japan
TEL
090-7200-9888
hkonuma@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironori Konuma |
Organization
Juntendo Nerima Hospital
Division name
Gastroenterology
Zip code
Address
3-1-10 Takanodai, Nerima-ku, Tokyo 177-8521, Japan
TEL
090-7200-9888
Homepage URL
hkonuma@juntendo.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
nothing
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
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
順天堂大学医学部付属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 01 | 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
The 12 locations were 1) lesions at the esophagogastric junction; 2) fornix; 3) lesser curvature of the gastric body; 4) greater curvature of the gastric body;5) anterior wall of the gastric body; 6) posterior wall of the gastric body; 7) lesion across the angle; 8) lesser curvature of the antrum; 9) greater curvature of the antrum;10) anterior wall of the antrum; 11) posterior wall of the antrum; and 12) lesion across from the pylorus ring. A significant difference was found in circumference incision speed (CIS) and submucosal dissection speed (SDS) for each location (p < 0.01), which demonstrates the validity of this classification system. In several locations, CIS and SDS were not consistent with each other.
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
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 01 | Day |
Other
Other related information
no special instruction
Management information
Registered date
| 2016 | Year | 06 | Month | 21 | Day |
Last modified on
| 2016 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026017
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