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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013560
Receipt No. R000015560
Scientific Title A Multicenter Prospective Randomized Study of 8mm versus 10mm Fully Covered Metallic Stent in Patients with Distal Malignant biliary Obstruction
Date of disclosure of the study information 2014/05/01
Last modified on 2019/04/03

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Basic information
Public title A Multicenter Prospective Randomized Study of 8mm versus 10mm Fully Covered Metallic Stent in Patients with Distal Malignant biliary Obstruction
Acronym Nagoya Biliary Stent Study (NABIS study)
Scientific Title A Multicenter Prospective Randomized Study of 8mm versus 10mm Fully Covered Metallic Stent in Patients with Distal Malignant biliary Obstruction
Scientific Title:Acronym Nagoya Biliary Stent Study (NABIS study)
Region
Japan

Condition
Condition case of unresectable malignant distal biliary obstruction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare clinical efficacy of 8mm Fully Covered Metalic Stent with 10mm Fully Covered Metalic Stent
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes patency period of stent
Key secondary outcomes Overall survival, frequency of adverse event, kinds of adeverse event, stent patency rate at patients' death

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 8mm Fully Covered Metalic Stent
Interventions/Control_2 10mm Fully Covered Metalic Stent
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Case of unresectable malignant distal biliary obstruction
Patients with accurate diagnosis of malignancy
Key exclusion criteria Performance status 4
Estimated life expectancy less than 3 months
Severe neurologic
impairment or mental disorder and
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yoshiki
Middle name
Last name Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code 466-8550
Address 65 Tsuruma-cho, Showa-ku, Nagoya, Japan
TEL +81-52-744-2602
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Kawashima
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterology and Hepatology
Zip code 466-8550
Address 65 Tsuruma-cho, Showa-ku, Nagoya, Japan
TEL +81-52-744-2602
Homepage URL
Email h-kawa@med.nagoya-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Boston Scientific Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Boards of Nagoya University Hospital
Address 65 Tsuruma-cho, Showa-ku, Nagoya, Japan
Tel 052-744-2061
Email iga-shinsa@adm.nagoya-u.ac.jp

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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 01 Day

Related information
URL releasing protocol https://onlinelibrary.wiley.com/journal/14431661
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/journal/14431661
Number of participants that the trial has enrolled 202
Results Median TRBOs did not differ significantly between the 8-mm (n=102) and 10-mm (n=100) groups (275 vs. 293 days, P=0.971). The hazard ratio of the 8-mm to 10-mm groups was 0.90 (80% confidence interval 0.77-1.04, upper limit lower than the acceptable hazard ratio (1.33) of the null hypothesis). Based on these findings, the 8-mm diameter stent was determined to be non-inferior to the 10-mm diameter stent.
Results date posted
2019 Year 04 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics A total of 202 eligible patients were enrolled, with 102 and 100 patients allocated to the 10-mm and 8-mm groups, respectively.
Participant flow The median TRBO was 293 days in the 10-mm group and 275 days in the 8-mm group, with no significant difference between the groups (P=0.971, log-rank test) (Figure 2). The HR of the 8-mm to 10-mm group in the Cox proportional hazard model was 0.90. The 80% CI using the Wald method corresponding to a one-sided significance level of 10% was 0.77-1.04, in which the upper limit of the 80% CI was smaller than the acceptable HR (1.33) of the null hypothesis. Based on this, the 8-mm diameter FCSEMS was judged to be non-inferior to the 10-mm diameter FCSEMS with regard to TRBO.
Adverse events Cholecystitis developed in 16 (8.1%) of the 198 patients, including 10 (10.2%) in the 10-mm group and 6 (6%) in the 8-mm group (P=0.278, Table 2). Cholecystitis developed within one week, suggesting a direct influence of stent placement, in 4 (4.1%) and 1 (1%) patients in the 10-mm and 8-mm groups, respectively, with no significant difference between the groups (P=0.167). Cholecystitis was improved by conservative treatment in 4 patients, but percutaneous drainage was needed in 12 patients. The median onset period was 10.5 days after stent placement (range: 2-363 days, showing wide variation). Pancreatitis developed in 14 (7.1%) of 198 patients, including 4 (4.1%) in the 10-mm group and 10 (10%) in the 8-mm group. The difference was not significant (P=0.104, Table 2). Pancreatitis was severe in one patient with distal bile duct carcinoma in the 10-mm group and moderate in one patient with pancreatic carcinoma in the 8-mm group, but mild in the other 12 patients, and was conservatively improved in all patients. Pain at stent insertion occurred in 28 patients, including 17 (17.3%) in the 10-mm group and 11 (11%) in the 8-mm group, with no significant difference between the groups (P= 0.200, Table 2). Other adverse events included perforation during insertion in one patient in the 8-mm group and hemorrhage from a duodenal ulcer on the opposite side of the papilla in one patient in the 10-mm group.
Outcome measures In conclusion, a prospective randomized multicenter study using the WallFlex Biliary RX Fully Covered Stent showed that an 8-mm diameter FCSEMS was not inferior to a 10-mm diameter FCSEMS for TRBO or the incidence of adverse events. These findings may be important in further development of SEMS.

Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 04 Month 20 Day
Date of IRB
2014 Year 06 Month 09 Day
Anticipated trial start date
2014 Year 06 Month 09 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded
2017 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 30 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015560

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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