UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030796
Receipt number R000035166
Scientific Title Examination of the usefulness of the sentinel lymph node navigation for esophageal cancer
Date of disclosure of the study information 2018/01/15
Last modified on 2019/09/27 09:05:04

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Basic information

Public title

Examination of the usefulness of the sentinel lymph node navigation for esophageal cancer

Acronym

Examination of the usefulness of the sentinel lymph node navigation for esophageal cancer

Scientific Title

Examination of the usefulness of the sentinel lymph node navigation for esophageal cancer

Scientific Title:Acronym

Examination of the usefulness of the sentinel lymph node navigation for esophageal cancer

Region

Japan


Condition

Condition

esophageal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

For an esophageal cancer patient, to evaluate the usefulness about feasibility of the appropriate method choice based on the sentinel lymph node theory by inspecting it among the art of the sentinel lymph node navigation in standard operation treatment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Detection rate of the sentinel lymph node

Key secondary outcomes

Accuracy of the sentinel lymph node
The rate of adverse events
Sentinel lymph node identification rate
distribution, metastasis situation,
metastasis detectivity,
Dectection rate of each of pathological type and tumor depth,


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

Diagnosis

Type of intervention

Medicine Maneuver

Interventions/Control_1

Sentinel lymph node navigation

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) age20-80
2) cT1-T3N0-1 histological proven esophageal cancer
3) untreated preoperatively (except for endoscopic resection)
4)ECOG PS0-1
5)capable of oral intake
6)written informed consent

Key exclusion criteria

1)pregnant and to have hisory of drug allergy or the asthma.
2)to have history of treatment for other cancer within 5 years (except for the cases that undergone endoscopic radical resection)
3) untreated other cancers
4) uncontrollable organ failure
5) active infectious diseases
6) Decison as adequate cases by a donctor in charge.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hisahiro
Middle name
Last name Matsubara

Organization

Chiba University

Division name

Frontier Surgery

Zip code

260-8677

Address

1-8-1 Chuo-Ku, Chiba City, Chiba Pref.

TEL

043-226-2110

Email

matsuhm@chiba-u.jp


Public contact

Name of contact person

1st name Masayuki
Middle name
Last name Kano

Organization

Chiba University

Division name

Frontier Surgery

Zip code

260-8677

Address

1-8-1 Chuo-Ku, Chiba City, Chiba Pref.

TEL

043-226-2110

Homepage URL


Email

mkano@chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Frontier Surgery, Chiba University

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

Clinical Reseach Center, Chiba University Hospital

Address

1-8-1 Inohana Chuo-Ku, Chiba City, Chiba Pref., Japan

Tel

043-222-7171

Email

ccrc-jim@chiba-u.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

千葉大学医学部附属病院(千葉)


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 15 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

Open public recruiting

Date of protocol fixation

2017 Year 12 Month 11 Day

Date of IRB

2017 Year 12 Month 06 Day

Anticipated trial start date

2017 Year 12 Month 11 Day

Last follow-up date

2022 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 13 Day

Last modified on

2019 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035166


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name