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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026245
Receipt No. R000030144
Scientific Title Preoperative evaluation of longitudinal tumor extent of extrahepatic cholangiocarcinoma using SpyGlass DS: A prospective study
Date of disclosure of the study information 2017/02/21
Last modified on 2017/02/21

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Basic information
Public title Preoperative evaluation of longitudinal tumor extent of extrahepatic cholangiocarcinoma using SpyGlass DS: A prospective study
Acronym Preoperative evaluation of longitudinal tumor extent of extrahepatic cholangiocarcinoma using SpyGlass DS: A prospective study
Scientific Title Preoperative evaluation of longitudinal tumor extent of extrahepatic cholangiocarcinoma using SpyGlass DS: A prospective study
Scientific Title:Acronym Preoperative evaluation of longitudinal tumor extent of extrahepatic cholangiocarcinoma using SpyGlass DS: A prospective study
Region
Japan

Condition
Condition extrahepatic cholangiocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of SpyGlass DS for preoperative evaluation of a longitudinal tumor extent of extrahepatic cholangiocarcinoma in comparison with other modalities.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1)The diagnostic accuracy of longitudinal tumor extent using SpyDS.
(2)The diagnostic accuracy of longitudinal tumor extent using other modalties.
Key secondary outcomes

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

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria possibly operable extrahepatic cholangiocarcinoma/obtaining written informed consent about participating study
Key exclusion criteria transpapillary approach is impossible/definitely inoperable case/choosing non-surgical treatment/under the age 18/pregnancy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahisa Ogawa
Organization Sendai City Medical Center
Division name Department of Gastroenterology
Zip code
Address 5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL 022-252-1111
Email t-ogawa@openhp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahisa Ogawa
Organization Sendai City Medical Center
Division name Department of Gastroenterology
Zip code
Address 5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL 022-252-1111
Homepage URL
Email t-ogawa@openhp.or.jp

Sponsor
Institute Sendai City Medical Center
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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
2016 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not particular

Management information
Registered date
2017 Year 02 Month 21 Day
Last modified on
2017 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030144

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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