UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015310
Receipt number R000017808
Scientific Title A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye.
Date of disclosure of the study information 2014/11/01
Last modified on 2019/07/26 14:25:58

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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 or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017808


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name