UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the relation between cholangiography findings and patency of multiple metal stents at the hilar bile duct
Title of the study (Brief title)	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	Yoshihide Kanno
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
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	Yoshihide Kanno
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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
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