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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022820
Receipt No. 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

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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
Email 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
Email hkonuma@juntendo.ac.jp

Sponsor
Institute Department of Gastroenterology, Juntendo University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026017

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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