UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility of sentinel node mapping as the index of metastasis in early gastric cancer following endoscopic resection: A phase II trial
Acronym	Feasibility of sentinel node as the index of metastasis in early gastric cancer following endoscopic resection: A phase II trial
Scientific Title	Feasibility of sentinel node mapping as the index of metastasis in early gastric cancer following endoscopic resection: A phase II trial
Scientific Title:Acronym	Feasibility of sentinel node as the index of metastasis in early gastric cancer following endoscopic resection: A phase II trial
Region	Japan

Condition
Condition	Gastric cancer following endoscopic resection
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the availability and safety of the gastrectomy with sentinel node mapping for early gastric cancer following endoscopic resection
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Diagnostic accuracy for lymph node metastases
Key secondary outcomes	Detection rate Distribution Sensitivity Adverse events

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	Medicine Device,equipment
Interventions/Control_1	Gastrectomy and lymphadenectomy according to the Japanese guideline with dual tracer method using a radioactive colloid and blue dye
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with a single tumor <4cm in diameter required additional surgery following endoscopic resection. 1) Pathological T1a (M), differentiated-type adenocarcinoma with ulceration, 3 cm< 2) pT1a (M), undifferentiated-type without ulceration, 2cm< 3) pT1a (M), undifferentiated-type with ulceration 4) pT1b (SM1) differentiated-type without ulceration, 3cm< 5) pT1b (SM1) with ulceration 6) pT1b (SM2/3) 7) vascular invasion positive 8) resection margin positive Within 3 months from endoscopic resection to surgery Written informed consent
Key exclusion criteria	Pregnancy Past history of severe drug allergy Asthma Active other primary malignancies Patients whom doctors judged inadequate to the enrollment of this study by other reasons Gastric remnant cancer
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuko Kitagawa
Organization	School of Medicine, Keio University
Division name	Department of Surgery
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3802
Email	kitagawa@a3.keio.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroya Takeuchi
Organization	School of Medicine, Keio University
Division name	Department of Surgery
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3802
Homepage URL
Email	htakeuchi@a6.keio.jp

Sponsor
Institute	Japanese Society for sentinel node navigation surgery
Institute
Department

Funding Source
Organization	None
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

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 10 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
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	Terminated
Date of protocol fixation	2012 Year 11 Month 02 Day
Date of IRB	2013 Year 03 Month 19 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date	2015 Year 10 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 04 Month 09 Day
Last modified on	2020 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012222