UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study to detect sentinel lymph nodes for endometrial cancers
Title of the study (Brief title)	Clinical study on sentinel lymph nodes in endometrial cancers
Region	Japan

Condition
Condition	Endometrial cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Nobuyuki Susumu
Organization	School of Medicine, Keio University
Division name	Department of Obstetrics and Gynecology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211(ext.62386)
Email	susumu35@a6.keio.jp

Public contact
Name of contact person	Nobuyuki Susumu
Organization	School of Medicine, Keio University
Division name	Department of Obstetrics and Gynecology
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

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

Funding Source
Organization	Department of Obstetrics and Gynecology, School of Medicine, Keio University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 14 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2008 Year 07 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://kompas.hosp.keio.ac.jp/contents/medical_info/presentation/201102.html
Results
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.

Management information
Registered date	2012 Year 05 Month 14 Day
Last modified on	2017 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009364