UMIN-CTR Clinical Trial

Public title

Clinical study to detect sentinel lymph nodes for endometrial cancers

Acronym

Clinical study on sentinel lymph nodes in endometrial cancers

Scientific Title

Clinical study to detect sentinel lymph nodes for endometrial cancers

Scientific Title:Acronym

Clinical study on sentinel lymph nodes in endometrial cancers

Region

Japan

Condition

Endometrial cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To calculate the detecting rate, sensitivity and false negative rate in sentinel node navigation system (SNNS) for endometrial cancer and to determine the validity of less-invasive surgery using SNNS with the aim of clinical application of SNNS.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

detecting rate, sensitivity and false negative rate, negative predective value, detecting rate of micrometastasis and isolated tumor cells

Key secondary outcomes

learning curve of detecting rate and time needed for sentinel nodes, detecting rates and sentinel node distributions depending on detecting methods and injection sites of tracers, diagnostic accuracy of touch smear of sentinel lymph nodes, diagnostic accuracies of metastasis to lymph nodes in pre-operative PET-CT and sentinel lymph nodes.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

One day before surgery, 99mTc-labeled phytic acid is injected with hysteroscopy around and intra-tumor submucosal myometrial layer, and approximately 15 hours later, just prior to operation, lymphoscintigraphy or SPECT is performed, and SNs are detected using gamma probe (RI method) during operation. After opening abdominal cavity, or laparoscopically, indocyanine green is injected subserosally to the uterine corpus, and SNs are deteceted with naked eyes (dye method) or with near-infrared fluorescence system (fluorescence method). SNs are principally detected with both methods (RI method and dye method or fluorescence method). SNs are pathologically investigated with frozen sections intraoperatively. Regardless of the results of frozen sections, standard retroperitoneal lymph node dissection is performed and we finally evaluate the safety and efficacy of SNNS by pathological investigation with paraffin sections with cytokeratin immunohistochemistry.

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

Female

Key inclusion criteria

(1)Pathologically-diagnosed endometrial cancer patients with no definite matastasis who are scheduled to receive operation including standard retroperitoneal lymph node dissection.
(2)Female patients of twenty and over who yield written consent.

Key exclusion criteria

(1)Patients suspicious of positive lymph node metastasis on pre-operative CT/MRI images.
(2)Patients with other malignancies.

Target sample size

122

Name of lead principal investigator

1st name
Middle name
Last name	Nobuyuki Susumu

Organization

School of Medicine, Keio University

Division name

Department of Obstetrics and Gynecology

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211(ext.62386)

Email

susumu35@a6.keio.jp

Name of contact person

1st name
Middle name
Last name	Nobuyuki Susumu

Organization

School of Medicine, Keio University

Division name

Department of Obstetrics and Gynecology

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211(ext.62386)

Homepage URL

http://www.studioasia.jp/dev/keiohos/obgyn/web-2010/04research/12announce.html

Email

susumu35@a6.keio.jp

Institute

Department of Obstetrics and Gynecology, School of Medicine, Keio University

Institute

Department

Personal name

Organization

Department of Obstetrics and Gynecology, School of Medicine, Keio University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院（東京都）

Date of disclosure of the study information

2012

Year

05

Month

14

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

http://kompas.hosp.keio.ac.jp/contents/medical_info/presentation/201102.html

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

Open public recruiting

Date of protocol fixation

2008

Year

07

Month

18

Day

Date of IRB

Anticipated trial start date

2008

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Abstract of a paper submitted to 2014 International Gynecologic Cancer Society.
A hysteroscopic endometrial radio isotope injection method and a fluorescence detecting method might be suitable to detect sentinel lymph node in para-aortic region in patients with endometrial cancer
Wataru Yamagami, Nobuyuki Susumu, Fumio Kataoka, Daisuke Aoki, et al.
Aims
A sentinel node (SN) navigation surgery is thought to be one of minimally invasive surgery for endometrial cancer. Regional lymph nodes of endometrial cancer are distributed in pelvic and para-aortic regions. The aim of this study is to clarify the suitable procedure for SN mapping.
Methods
The subjects were 89 patients that were diagnosed with endometrial cancer and were obtained written informed consent. We performed RI method (RI injection into endometrium (RI-EM) or into endocervix (RI-EC)) and dye method (green dye to subserosa (GD) or GD detected by fluorescence (FL)) for SN mapping. We investigated the detection rate, site, and number of SNs identified by each method. This study was approved by the Ethical Review committee at our institution.
Results
Metastatic rates of SNs were 6% and 8% in pelvic and para-aortic SNs. Twenty-two percent of patients with metastatic SNs had metastasis only in para-aortic lesion. The detection rates of pelvic SNs were 97%, 98%, 97%, and 90% by GD, FL, RI-EM, RI-EC methods, respectively. However, the detection rates of para-aortic SNs were 65%, 80%, 80%, and 35%, respectively. The detection rate by RI-EM method was significantly higher than that by RI-EC method. The detection rate by FL method tended to be higher than that by GD method. There was no difference of adverse effects in each method.
Conclusion
It was considered to be important to detect para-aortic SNs as well as pelvic SNs. RI-EM method or FL method might be suitable to detect SNs in para-aortic region.

Registered date

2012

Year

05

Month

14

Day

Last modified on

2017

Year

05

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009364