UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic submucosal dissection for neoplasia of the greater curvature of the upper and middle stomach: J-shaped superficial cutting and splashed dissection
Title of the study (Brief title)	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	Noriko Nishiyama
Organization	Faculty of Medicine, Kagawa University
Division name	Department of Gastroenterology
Address	1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL	087-891-2156
Email	n-nori@med.kagawa-ua.c.jp

Public contact
Name of contact person	Noriko Nishiyama
Organization	Faculty of Medicine, Kagawa University
Division name	Department of Gastroenterology
Address	1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL	087-891-2156
Homepage URL
Email	n-nori@med.kagawa-ua.c.jp

Sponsor
Institute	Faculty of Medicine, Kagawa University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2008 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037303