UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025539 |
|---|---|
| Receipt number | R000029395 |
| Scientific Title | Observational study on EUS-guided biliary drainage for malignant perihilar biliary strictures after further transpapillary interventions were judged to be no longer impossible or ineffective |
| Date of disclosure of the study information | 2017/01/05 |
| Last modified on | 2017/01/05 14:38:31 |
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Basic information
Public title
Observational study on EUS-guided biliary drainage for malignant perihilar biliary strictures after further transpapillary interventions were judged to be no longer impossible or ineffective
Acronym
Study on EUS-BD for hilar malignancy
Scientific Title
Observational study on EUS-guided biliary drainage for malignant perihilar biliary strictures after further transpapillary interventions were judged to be no longer impossible or ineffective
Scientific Title:Acronym
Study on EUS-BD for hilar malignancy
Region
| Japan |
Condition
Condition
Finished
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients who underwent EUS-BD after further transpapillary intervention were judged to be no longer impossible or ineffective
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical efficacy
Key secondary outcomes
Procedure-related adverse events, , time to recurrence of jaundice or infectious cholangitis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent EUS-BD after further transpapillary intervention were judged to be no longer impossible or ineffective at Sendai City Medical Center between 2007 and 2016
Key exclusion criteria
Those who had not receive previous interventions via the papilla
Target sample size
7
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, Miyagino-ku, Sendai, 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, Miyagino-ku, Sendai, 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 | 01 | Month | 05 | 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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There are 7 patients eligible for the study between 2007 and 2016 (7 men; mean age, 77 years; 4 with perihilar cholangiocarcinoma and 3 with intrahepatic cholangiocarcinoma). No procedure-related adverse events were observed. EUS-BD was clinically effective in 4 patient (57%), and enabled hospital discharge in 4 patients. The each NRT in 4 clinically effective patients was 43, 105, 118, and 147 days after the procedure (median, 112 days). The median survival period after the EUS-BD was 14 days (6-29 days) in clinically non-effective patients and 179 days (99-273 days) in clinically effective patients.
Management information
Registered date
| 2017 | Year | 01 | Month | 05 | Day |
Last modified on
| 2017 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029395
