UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009932 |
|---|---|
| Receipt number | R000011635 |
| Scientific Title | A novel endoscopic approach to severe strictures of the biliary or main pancreatic duct using a diathermic sheath |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2013/08/01 13:21:06 |
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Basic information
Public title
A novel endoscopic approach to severe strictures of the biliary or main pancreatic duct using a diathermic sheath
Acronym
Diathermic sheath study
Scientific Title
A novel endoscopic approach to severe strictures of the biliary or main pancreatic duct using a diathermic sheath
Scientific Title:Acronym
Diathermic sheath study
Region
| Japan |
Condition
Condition
Severe strictures of the biliary or main pancreatic duct
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study prospectively evaluated the feasibility, safety, and clinical outcomes of an endoscopic approach using a diathermic sheath for severe BD/MPD strictures
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility, safety of Diathermic sheath
Key secondary outcomes
Complication of Diathermic sheath
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 |
Interventions/Control_1
Diathermic sheath(6-Fr, Cysto-Gastro-Set; Endo-Flex, Voerde, Germany)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A diathermic sheath was used when a tapered ERCP catheter, balloon catheter, Soehendra biliary dilation catheter, or Soehendra stent retriever (Cook-Japan, Tokyo, Japan) could not be passed across the stricture after a guidewire was passed across the stricture.
Key exclusion criteria
1)Impossible case of ERCP
2)Impossible case of selective cannulation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kawakami |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-716-1161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kawakami |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-716-1161
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 01 | Day |
Last modified on
| 2013 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011635
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
