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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024614
Receipt No. R000028284
Scientific Title Diagnostic and therapeutic single operator cholangiopancreatoscopy using SpyGlass DS in biliopancreatic diseases:A prospective multicenter registry study
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/26

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Basic information
Public title Diagnostic and therapeutic single operator cholangiopancreatoscopy using SpyGlass DS in biliopancreatic diseases:A prospective multicenter registry study
Acronym Japan SpyGlass DS Registry
Scientific Title Diagnostic and therapeutic single operator cholangiopancreatoscopy using SpyGlass DS in biliopancreatic diseases:A prospective multicenter registry study
Scientific Title:Acronym Japan SpyGlass DS Registry
Region
Japan

Condition
Condition Biliary and pancreatic diseases in need of cholangiopancreatoscopy diagnosis and treatment
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of single-operator cholangiopancreatoscopy (SOCPS) using theSpyGlass DS in widespread clinical application for biliary and pancreatic diseases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. SpyGlass DS procedural success rate
2. Evaluation of serious adverse events (SAEs) related to the SpyGlass DS devices and/or the SpyGlass DS procedure
Key secondary outcomes 1. Time of SpyGlass DS procedure and ERCP procedure
2. Visible region of biliary duct or pancreatic duct using SpyGlass DS
3. Impact of SpyGlass DS procedure on patient management
4. Evaluation of impact of use of antibiotics on incidence of SAEs related to the device and/or procedure
5. Diagnostic accuracy of SpyBite histopathology
6. Efficacy of SpyGlass DS procedure for stone management

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 Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Cholangiopancreatoscopy diagnosis and treatment using the Spyglass DS
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 Male and Female
Key inclusion criteria 1. Age 20 or older
2. Willing and able to provide written informed consentto participate in the study
3. Willing and able to comply with the study procedures
4. Indicated for ERCP and cholangioscopy or indicated forERCP with suspected need for cholangioscopy
Key exclusion criteria 1. Endoscopic techniques are contraindicated
2. ERCP is contraindicated
3. Requirement for anticoagulation that cannot be safely stopped
4. Other, the patients deemed unsuitable for carrying out the present study by the attending physician
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Itoi
Organization Tokyo Medical University
Division name Department of Gastroenterology a nd Hepatology
Zip code
Address 6-7-1, Nishishinjyuku, Shinjyukuku, Tokyo
TEL 03-3342-6111
Email itoi@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Itoi
Organization Tokyo Medical University
Division name Department of Gastroenterology a nd Hepatology
Zip code
Address 6-7-1, Nishishinjyuku, Shinjyukuku, Tokyo
TEL 03-3342-6111
Homepage URL
Email itoi@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization Boston Scientific
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 1. 東京医科大学病院 (東京都)
2. 東京大学医学部附属病院 (東京都)
3. 帝京大学医学部附属溝口病院 (神奈川県)
4. 近畿大学医学部附属病院 (大阪府)
5. 医療法人手稲渓仁会病院 (北海道)
6. 秋田大学医学部附属病院 (秋田県) 
7. 仙台市医療センター仙台オープン病院 (宮城県)
8. 福島県立医科大学会津医療センター (福島県)
9. 温知会 会津中央病院 (福島県)
10. 埼玉医科大学国際医療センター(埼玉県)
11. 千葉県がんセンター (千葉県)
12. 東邦大学医療センター大橋病院(東京都)
13. 昭和大学横浜市北部病院 (神奈川県)
14. 医療法人沖縄徳洲会 湘南鎌倉総合病院 (神奈川県)
15. 愛知県がんセンター中央病院 (愛知県)
16. 名古屋市立大学病院 (愛知県)
17. 大阪医科大学附属病院 (大阪府)
18. 神戸大学医学部附属病院 (兵庫県)
19. 川崎医科大学附属川崎病院 (岡山県)
20. 大原記念倉敷中央医療機構 倉敷中央病院 (岡山県)
21. 広島県農業協同組合連合会 尾道総合病院 (広島県)
22. 久留米大学病院 (福岡県)
23. 九州大学病院 (福岡県)
24. 沖縄県立中部病院 (沖縄県)
25. 和歌山県立医科大学附属病院 (和歌山県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 01 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
2016 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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

Management information
Registered date
2016 Year 10 Month 28 Day
Last modified on
2016 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028284

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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