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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030583
Receipt No. R000034923
Scientific Title Retrospective study on acceptability of a newly developed cholangioscope, SpyGlass DS, for evaluation of the lateral spread of extrahepatic cholangiocarcinoma
Date of disclosure of the study information 2017/12/26
Last modified on 2017/12/26

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Basic information
Public title Retrospective study on acceptability of a newly developed cholangioscope, SpyGlass DS, for evaluation of the lateral spread of extrahepatic cholangiocarcinoma
Acronym SpyGlass DS for diagnosis of lateral spread of cholangiocarcinoma
Scientific Title Retrospective study on acceptability of a newly developed cholangioscope, SpyGlass DS, for evaluation of the lateral spread of extrahepatic cholangiocarcinoma
Scientific Title:Acronym SpyGlass DS for diagnosis of lateral spread of cholangiocarcinoma
Region
Japan

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

Objectives
Narrative objectives1 A newly developed peroral cholangioscopy (POCS) system, SpyGlass DS (Boston Scientific Co.) has high maneuverability, whereas its image quality appears relatively low in comparison with that of a traditional cholangioscope, CHF-B260 (Olympus Co.). This study aimed to evaluate acceptability of the accuracy of SpyGlass DS accompanied by simultaneous POCS-guided biopsy compared with that of CHF-B260 after fluoroscopy-guided biopsy to diagnose the lateral extent of extrahepatic cholangiocarcinoma (LEC).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The main outcome measure was the accuracy of overall preoperative diagnosis (OPD) of LEC which was defined based on all examinations, including POCS, and was evaluated with reference to the resected specimen.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients who underwent surgical resection after preoperative examinations to diagnose LEC were evaluated
Key exclusion criteria (1) those in whom the clinical record on findings of the POCS examination could not be obtained or was insufficient for evaluation, (2) those who did not undergo surgical resection after examinations, and (3) those in whom the resected specimen was inappropriate to precisely evaluate the lateral extent.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihide Kanno
Organization Sendai City Medical Center
Division name Department of Gastroenterology
Zip code
Address 5-22-1, Tsurugaya, Sendai, Miyagi, Japan
TEL 81222521111
Email yoshi-hk@openhp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihide Kanno
Organization Sendai City Medical Center
Division name Department of Gastroenterology
Zip code
Address 5-22-1, Tsurugaya, Sendai, Miyagi, Japan
TEL 81222521111
Homepage URL
Email yoshi-hk@openhp.or.jp

Sponsor
Institute Sendai City Medical Center
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 26 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 Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All data on patients who underwent surgical resection for extrahepatic bile duct cancer after preoperative examinations, including POCS, to diagnose the lateral extent of extrahepatic cholangiocarcinoma at Sendai City Medical Center were extracted from a prospectively maintained database of endoscopic retrograde cholangiopancreatography.

Management information
Registered date
2017 Year 12 Month 26 Day
Last modified on
2017 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034923

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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