UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030583 |
|---|---|
| Receipt number | 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 22:06:38 |
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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
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
yoshi-hk@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034923
