UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Laparoscopic preventive lymphadenectomy after endoscopic submucosal dissection (ESD) for early gastric cancer
Title of the study (Brief title)	Laparoscopic lymphadenectomy after endoscopic submucosal dissection (ESD) for early gastric cancer
Region	Japan

Condition
Condition	Early gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will evaluate the curability and less invasiveness of endoscopic submucosal dissection (ESD) with laparoscopic lymphadenectomy for early gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relapse-free survival
Key secondary outcomes	Success rate, intra and post-operative morbidity, and overall survival rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	We will performe laparoscopic preventative lymphadenectomy after ESD for early gastric cancer.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Early gastric cancer patient Informed consent
Key exclusion criteria	Lymph node metastasis Distant metastasis
Target sample size	100

Research contact person
Name of lead principal investigator	Haruhiro Inoue, MD, PhD
Organization	Showa University Koto Toyosu Hospital
Division name	Digestive Disease Center
Address	5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
TEL	03-6204-6000
Email	haruinoue777@yahoo.co.jp

Public contact
Name of contact person	Haruhiro Inoue, MD, PhD
Organization	Showa University Koto Toyosu Hospital
Division name	Digestive Disease Center
Address	5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
TEL	03-6204-6000
Homepage URL
Email	haruinoue777@yahoo.co.jp

Sponsor
Institute	Digestive Disease Center, Showa University Koto Toyosu Hospital
Institute
Department

Funding Source
Organization	Digestive Disease Center, Showa University Koto Toyosu Hospital
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	昭和大学江東豊洲病院　消化器センター

Other administrative information
Date of disclosure of the study information	2011 Year 01 Month 09 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2008 Year 06 Month 01 Day
Anticipated trial start date	2008 Year 06 Month 01 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

Management information
Registered date	2011 Year 01 Month 09 Day
Last modified on	2017 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005775