UMIN-CTR Clinical Trial

Basic information
Public title	A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye.
Acronym	A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye.
Scientific Title	A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye.
Scientific Title:Acronym	A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye.
Region	Japan

Condition
Condition	Esophageal cancer/ Gastric cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the availability and safety of nodal evaluation of metastasis and individualized gastrectomy based on sentinel node biopsy for patients with cN0 esophageal cancer or gastric cancer .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy of nodal evaluation of metastasis based on sentinel node biopsy.
Key secondary outcomes	Number of identified SNs, Detection rate of sentinel nodes, sensitivity to detect lymph node metastasis based on sentinel node biopsy, negative predictive value of lymph node metastasis.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	We use radioisotope and blue stain as a tracer, and perform SN mapping. We diagnose metastasis of SN by intraoperative and frozen tissue examination.
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	1) Age 20 to 80 2) Esophageal cancer or gastric cancer patients with no nodal metastasis nor distant metastasis. 3) Tumor with single lesion. 4) Provided with written informed conscent. 5) Histopathological results does not matter.
Key exclusion criteria	1) Pregnancy, severe drug allergy, asthoma. 2) Multiple tumor lesion or with synchronous or metachronous (within 5 years) malignancies. 3) With prior endoscopic treatment to same lesion. 4) Judged as irrelevant object for this study 5) Refusal of the trial entry 6) Absolute indication for endoscopic treatments
Target sample size	700

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Kitagawa
Organization	Keio University, School of Medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Email	kitagawa@a3.keio.jp

Public contact
Name of contact person	1st name Kazumasa Middle name Last name Fukuda
Organization	Keio University, School of Medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Homepage URL
Email	fukudak@z6.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
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	Keio University School of Medicine, Ethics Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel	03-5363-3503
Email	med-rinri-jimu@adst.keio.ac.jp

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	2014 Year 11 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
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 10 Month 07 Day
Date of IRB	2012 Year 12 Month 21 Day
Anticipated trial start date	2012 Year 12 Month 21 Day
Last follow-up date	2018 Year 02 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 10 Month 01 Day
Last modified on	2019 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017808