UMIN-CTR Clinical Trial

Public title

The efficacy of the sentinel node navigation surgery for early gastric cancer

Acronym

SNNS for EGC

Scientific Title

The efficacy of the sentinel node navigation surgery for early gastric cancer

Scientific Title:Acronym

SNNS for EGC

Region

Japan

Condition

early gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The effectiveness and disadvantage of the sentinel node navigation surgery for early gastric cancer will be investigated in comparison with the surgery according to the Japanese guideline. In this observational study, the patients suffered from early gastric cancer will be performed limited surgery with a tailored lymph node dissection if they are diagnosed negative for nodal metastasis using the intraoperative sentinel node biopsy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

The occurrence rate of the postoperative morbidity

Key secondary outcomes

The occurrence rate of the postoperative symptoms
Disease free survival
Overall survival
Rate of the metachronous multiple gastric cancers
Parameters of the surgery between the surgical procedures

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The patients suffered from early gastric cancer will be performed sentinel node biopsy using ICG fluorescent method. The candidate of the sentinel nodes will be send to the pathological section for intraoperative rapid diagnosis. If the patient will be diagnosed as node positive, he will be performed standard gastric resection with lymph node dissection up to D2 according to the Japanese Guideline. If the patient will be diagnosed as node negative, he will be performed limited surgery with a tailored lymph node dissection. We call this strategy as the sentinel node navigation surgery.
The effectiveness and disadvantage of the sentinel node navigation surgery will be investigated in comparison with the data of the patients of our institute in the past that were performed sentinel node biopsy and standard gastrectomy according to the Japanese guideline.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Having gastric cancer confirmed by the endoscopic biopsy
2) Over 20 years old
3) ECOG performance status 0-1
4) Tolerable for general anesthesia and gastric surgery
5) No preoperative chemotherapy for gastric cancer
6) cT1 cancer out of indication of EMR/ESD, or superficial cT2 cancer
7) Single cancer less than 4 cm in a diameter
8) cN0 diagnosed in preoperative X-CT

Key exclusion criteria

1) Having synchronous multiple gastric cancer
2) Having marked fibrosis caused by intractable gastric ulcer
3) Treating with huge dose of steroid
4) Having uncontrolled diabetes mellitus
5) Having severe drug allergy or bronchial asthma
6) Having intractable liver cirrhosis
7) Having psychological disorder and difficulty in decision by their own will
8) Other reasons considered by the investigator

Target sample size

90

Name of lead principal investigator

1st name	Takeo
Middle name
Last name	Kosaka

Organization

Kanazawa Medical University

Division name

Department of surgical oncology

Zip code

920-0293

Address

1-1 Daigaku, Uchinada, Kahoku, Ishikawa, Japan

TEL

0762862211

Email

tkosaka@kanazawa-med.ac.jp

Name of contact person

1st name	Shinichi
Middle name
Last name	Kinami

Organization

Kanazawa Medical University

Division name

Department of surgical oncology

Zip code

920-0293

Address

1-1 Daigaku, Uchinada, Kahoku, Ishikawa, Japan

TEL

0762862211

Homepage URL

Email

kinami@kanazawa-med.ac.jp

Institute

Department of surgical oncology, Kanazawa Medical University

Institute

Department

Personal name

Organization

Department of surgical oncology, Kanazawa Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kanazawa Medical University

Address

1-1 Daigaku, Uchinada, Kahoku, Ishikawa, Japan

Tel

0762862211

Email

kinami@kanazawa-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

金沢医科大学病院（石川県）

Date of disclosure of the study information

2013

Year

03

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2013

Year

01

Month

31

Day

Date of IRB

2013

Year

03

Month

04

Day

Anticipated trial start date

2013

Year

03

Month

04

Day

Last follow-up date

2023

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

03

Month

03

Day

Last modified on

2019

Year

09

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011891