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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015155
Receipt No. R000017625
Scientific Title Diagnostic and therapeutic single-operator cholangiopancreatoscopy in biliopancreatic diseases: Prospective multicenter study in Japan
Date of disclosure of the study information 2014/09/14
Last modified on 2014/09/14

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Basic information
Public title Diagnostic and therapeutic single-operator cholangiopancreatoscopy in biliopancreatic diseases: Prospective multicenter study in Japan
Acronym Utility and safety of Spyglass system
Scientific Title Diagnostic and therapeutic single-operator cholangiopancreatoscopy in biliopancreatic diseases: Prospective multicenter study in Japan
Scientific Title:Acronym Utility and safety of Spyglass system
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 Others
Genomic information NO

Objectives
Narrative objectives1 To assess the utility and safety of single-operator cholangiopancreatoscopy (SOCPS) using the Spyglass system 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 The main outcomes were related to the procedure success rate
Key secondary outcomes occurrence rate and kinds of adverse events

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 system
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 an indication for cholangiopancreatoscopy
Key exclusion criteria Excluded were patients with bleeding diatheses, distorted anatomy, severe jaundice or cholangitis, critically ill patients, and patients who were not able to give informed consent.
Target sample size 100

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 and Hepatology
Zip code
Address 6-7-1, Nishishinjyuku, Shinjyuku-ku, 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 and Hepatology
Zip code
Address 6-7-1, Nishishinjyuku, Shinjyuku-ku, Tokyo
TEL 03-3342-6111
Homepage URL
Email itoi@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University, Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Tokyo Medical University, Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor 1. Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo
2. First Department of Internal Medicine, Gifu University Hospital, Gifu
3. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo
4. Department of Medicine and Clinical Oncology, Chiba University Graduate School of Medicine, Chiba
5. Department of Gastroenterology, Chiba Cancer Center, Funabashi Municipal Hospital, Chiba
6. Department of Gastroenterology, National Hospital Organization, Kyushu Medical Center, Fukuoka
7. Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume
8. Digestive Disease Center, Onomichi General Hospital, Onomichi
9. Fourth Department of Internal Medicine, Sapporo Medical University School of Medicine, Sapporo
10. Department of Surgery and Oncology, Graduate School of Medical Sciences Kyushu University, Fukuoka
11. Department of Gastroenterology and Hepatology, Iwate Medical University School of Medicine, Morioka
12. Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Sapporo
13. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University School of Medicine, Tokyo
14. Department of Gastroenterology, Tottori University Hospital, Yonago
15. Department of Internal Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke
16. Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube
17. Department of Gastroenterology, Nagoya University Graduate School of Medicine, Nagoya
18. Department of Gastroenterology, Mutsu General Hospital, Mutsu
19. Division of Gastroenterology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo
20. Department of Gastroenterology, Mie University, Tsu
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. Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo
2. First Department of Internal Medicine, Gifu University Hospital, Gifu
3. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo
4. Department of Medicine and Clinical Oncology, Chiba University Graduate School of Medicine, Chiba
5. Department of Gastroenterology, Chiba Cancer Center, Funabashi Municipal Hospital, Chiba
6. Department of Gastroenterology, National Hospital Organization, Kyushu Medical Center, Fukuoka
7. Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume
8. Digestive Disease Center, Onomichi General Hospital, Onomichi
9. Fourth Department of Internal Medicine, Sapporo Medical University School of Medicine, Sapporo
10. Department of Surgery and Oncology, Graduate School of Medical Sciences Kyushu University, Fukuoka
11. Department of Gastroenterology and Hepatology, Iwate Medical University School of Medicine, Morioka
12. Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Sapporo
13. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University School of Medicine, Tokyo
14. Department of Gastroenterology, Tottori University Hospital, Yonago
15. Department of Internal Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke
16. Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube
17. Department of Gastroenterology, Nagoya University Graduate School of Medicine, Nagoya
18. Department of Gastroenterology, Mutsu General Hospital, Mutsu
19. Division of Gastroenterology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo
20. Department of Gastroenterology, Mie University, Tsu

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 14 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 No longer recruiting
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 10 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
2014 Year 09 Month 14 Day
Last modified on
2014 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017625

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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