UMIN-CTR Clinical Trial

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

case of unresectable malignant distal biliary obstruction

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Boston Scientific Japan

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

名古屋大学医学部附属病院（愛知県）

Date of disclosure of the study information

2014

Year

05

Month

01

Day

URL releasing protocol

https://onlinelibrary.wiley.com/journal/14431661

Publication of results

Published

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

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 related information

Registered date

2014

Year

03

Month

30

Day

Last modified on

2019

Year

04

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015560