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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007949
Receipt No. R000009364
Scientific Title Clinical study to detect sentinel lymph nodes for endometrial cancers
Date of disclosure of the study information 2012/05/14
Last modified on 2017/05/23

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Basic information
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
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
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

Public contact
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

Result
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

Progress
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
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/ctr_e/ctr_view.cgi?recptno=R000009364

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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