UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study of evaluating the impact on intraoperative ultrasonography to individualize systematic paraaortic lymph node dissection in gynecologic malignancy.
Title of the study (Brief title)	PAN US study
Region	Japan

Condition
Condition	gynecologic malignant disease who is plannig to tumor debulking with paraaortic lymoh nodes dissection
Classification by specialty	Obsterics and gynecology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	1)To examine intraoperative ultrasonography detect metastatic lymph node metastasis 2)The size of paraarotic lymph nodes detected by intraperative ultrasonography.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	metastatic paraaortic lymph nodes size that is detectable by intraoperative ultrasonography
Key secondary outcomes	comparison the power intraoperative ultrasonography with other modalities

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1 Gynecologic malignant patients who are planning systematic paraaortic lymph node dissection. 2.Necessity for informed consent
Key exclusion criteria	1. Having wish to preserve fertility 2.Inappropriate for this study by investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	Yoshio Itani
Organization	Nara prefecture General Hosptal
Division name	Ob & Gyn
Address	1-30-1 Hiramatsu Nara
TEL	0742-46-6001
Email	yitani@nara-hp.jp

Public contact
Name of contact person	Yoshio Itani
Organization	Nara prefectural Nara Hospital
Division name	Ob & Gyn
Address	1-30-1 Hiramatsu Nara
TEL	0742-46-6001
Homepage URL
Email	nuages@m3.kcn.ne.jp

Sponsor
Institute	Nara prefectural Nara Hospital Ob and Gyn
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Nara prefectural Nara Hospital Ob and Gyn
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	奈良県総合医療センター（奈良県）

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 11 Month 08 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2015 Year 04 Month 01 Day
Date of closure to data entry	2015 Year 04 Month 01 Day
Date trial data considered complete	2015 Year 04 Month 01 Day
Date analysis concluded	2015 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	prospective case controlled study

Management information
Registered date	2011 Year 06 Month 06 Day
Last modified on	2016 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006775