UMIN-CTR Clinical Trial

Public title

Study to optimize the number of lymph nodes collected by sentinel lymph node biopsy

Acronym

Optimized the number of sentinel lymph nodes removed

Scientific Title

Study to optimize the number of lymph nodes collected by sentinel lymph node biopsy

Scientific Title:Acronym

Optimized the number of sentinel lymph nodes removed

Region

Japan

Condition

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To prove that it is possible to keep the number of identified sentinel lymph nodes within a certain range by adjusting the drug injection amount with reference to BMI and age.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Percentage of cases in which the number of sentinel lymph nodes identified was 2-4

Key secondary outcomes

1: Proportion of cases in which the number of lymph nodes removed was 2 to 4, 2: Identification rate, 3: Relationship between the number of sentinel lymph nodes removed and clinicopathological factors

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

the ICG injection amount

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

Not applicable

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

A case of primary breast cancer with no clinically diagnosed lymph node metastasis

Key exclusion criteria

(1) Male breast cancer, (2) Patient with history of surgery on affected side breast and axilla, and normal lymphatic flow cannot be expected, (3) Iodine allergy

Target sample size

70

Name of lead principal investigator

1st name	Makita
Middle name
Last name	Masujiro

Organization

Nippon Medical School Musashikosugi Hospital

Division name

Department of breast surgery

Zip code

211-8533

Address

1-396 Kosugi-machi, Nakahara-ku, Kawasaki-shi, Kanagawa 211-8533, Japan.

TEL

044-733-5181

Email

m-makita@nms.ac.jp

Name of contact person

1st name	Makita
Middle name
Last name	Masujiro

Organization

Nippon Medical School Musashikosugi Hospital

Division name

Department of breast surgery

Zip code

211-8533

Address

1-396 Kosugi-machi, Nakahara-ku, Kawasaki-shi, Kanagawa 211-8533, Japan.

TEL

044-733-5181

Homepage URL

Email

m-makita@nms.ac.jp

Institute

Nippon Medical School Musashikosugi Hospital Department of breast surgery

Institute

Department

Personal name

Organization

Nippon Medical School Musashikosugi Hospital Department of breast surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nippon Medical School Musashikosugi Hospital Institutional Review Board

Address

1-396 Kosugi-machi, Nakahara-ku, Kawasaki-shi, Kanagawa 211-8533, Japan.

Tel

044-733-5181

Email

m-makita@nms.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

日本医科大学武蔵小杉病院（神奈川県）

Date of disclosure of the study information

2020

Year

07

Month

03

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

136

Results

The number of sentinel lymph nodes (SLN) identified 2-4 was defined as appropriate identification, and the appropriate identification rate was examined. The average number of SLNs identified was 4.1, and the appropriate identification rate was 54.4% (74/136), which was less than the target of 80%, but the SLN identification rate was 100%.

Results date posted

2022

Year

07

Month

03

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

From July 2020 to August 2021, 136 patients with primary breast cancer(Tis~T2N0) who had no clinical lymph node metastasis were enrolled.
Patient age, mean 58.4 years old

Participant flow

In SLN biopsy by indocyanine green (ICG) fluorescence method, the injection amount was increased or decreased by BMI based on the age x 0.1 ml, and the minimum was 0.3 ml and the maximum was 1.0 ml.　After the introduction of general anesthesia, ICG was injected intradermally, the surgical field was expanded so that the axilla could be sufficiently observed, and the lymph nodes were removed. If the lymph nodes had fluorescence, it was judged to be SLN.

Adverse events

None

Outcome measures

The appropriate identification rate was 54.4% (74/136)

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

06

Month

19

Day

Date of IRB

2020

Year

06

Month

29

Day

Anticipated trial start date

2020

Year

07

Month

01

Day

Last follow-up date

2021

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

07

Month

02

Day

Last modified on

2022

Year

07

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046803