UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Procedure time for gastric endoscopic submucosal dissection according to location, considering both sides of the mucosal circumferential incision and submucosal dissection ; retrospective study
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hironori Konuma
Organization	Juntendo Nerima Hospital
Division name	Gastroenterology
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	Hironori Konuma
Organization	Juntendo Nerima Hospital
Division name	Gastroenterology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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