UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023573 |
|---|---|
| Receipt number | R000027151 |
| Scientific Title | Study on the relation between cholangiography findings and patency of multiple metal stents at the hilar bile duct |
| Date of disclosure of the study information | 2016/08/10 |
| Last modified on | 2016/08/09 21:47:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on the relation between cholangiography findings and patency of multiple metal stents at the hilar bile duct
Acronym
ERC findings as a risk for stent dysfunction
Scientific Title
Study on the relation between cholangiography findings and patency of multiple metal stents at the hilar bile duct
Scientific Title:Acronym
ERC findings as a risk for stent dysfunction
Region
| Japan |
Condition
Condition
Malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients with perihilar obstruction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stent patency
Key secondary outcomes
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 endoscopic Multi-MS placement for malignant hilar biliary obstruction at our center between April 2007 and March 2015
Key exclusion criteria
Patients who were not followed up for more than 28 days after the procedure at our center
Target sample size
68
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, Sendai, Miyagi
TEL
+81(0)22-252-1111
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, Sendai, Miyagi
TEL
+81(0)22-252-1111
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
| 2016 | Year | 08 | Month | 10 | 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
Soft and fine surface texture of the perihilar malignancy in cholangiography was found to be a significant risk factor for a shorter time to dysfunction of multiple metal stents
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
| 2016 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Methods:
Among 97 patients who received multi-MS placement, 68 of them who were traceable for > 28 days were included and retrospectively analyzed. Univariate analyses with the log-rank test was carried out on twenty-four factors including two newly defined classifications of cholangiography: Classification A which classifies the rough image of the tumor (localized type [A1] or spreading type [A2]); and classification B which classifies the surface texture of the tumor (soft irregularity type [B1], solid irregularity type [B2], or smooth type [B3]).
Results:
Stent dysfunction occurred in 36 patients (53%) (median time, 209 days; 95%CI, 111-307) during the mean follow-up period of 277 days. The type B1 was a significant risk for short stent patency (median, 100 days in B1 [n = 18]; 231 in B2 [n = 38]; 356 in B3 [n = 12], p < 0.0001). In multivariate analysis, the type B1 was again the only independent factor among the 6 factors (male, classification A2 and B1, dysfunction of previously placed plastic stents, large number of previous interventions, active cholangitis, and chemotherapy not-performed) (HR 4.8, p < 0.001).
Management information
Registered date
| 2016 | Year | 08 | Month | 09 | Day |
Last modified on
| 2016 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027151
