UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015155 |
|---|---|
| Receipt number | 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 16:26:59 |
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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
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
itoi@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017625
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| Registered date | File name |
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