UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023573
Receipt No. 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

* 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
Email 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
Email yoshi-hk@openhp.or.jp

Sponsor
Institute Sendai City Medical Center
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027151

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.