UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025584 |
|---|---|
| Receipt number | R000029442 |
| Scientific Title | A Prospective Tolerability Study of Fully Covered Metallic Stent for Preoperative Biliary Drainage of Perihilar Cholangiocarcinoma |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2023/07/16 09:43:48 |
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Basic information
Public title
A Prospective Tolerability Study of Fully Covered Metallic Stent for Preoperative Biliary Drainage of Perihilar Cholangiocarcinoma
Acronym
NABIS-02 study
Scientific Title
A Prospective Tolerability Study of Fully Covered Metallic Stent for Preoperative Biliary Drainage of Perihilar Cholangiocarcinoma
Scientific Title:Acronym
NABIS-02 study
Region
| Japan |
Condition
Condition
Preoperative perihilar cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate tolerability of Fully Covered Metallic Stent for preoperative perihilar cholangiocarcinoma patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of cases who do not need stent exchange until surgical operation
Key secondary outcomes
Confirm the surgical operation safety and complication related stent and surgical operation of Fully Covered Metallic Stent for preoperative perihilar cholangiocarcinoma
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Exchange the drainage methods from ENBD to Fully covered Metallic Stent
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Operable perihilar cholangiocarcinoma. (image diagnosis)
Patients already inserted ENBD for future remnant liver lobe(s) and waiting periods more than 2 weeks to surgical operation.
More than 10mm of bile duct length from edge of upstream stricture site to the first biliary branch
PS(ECOG) 0 or 1
Adequate oral intake
Estimated life expectancy more than 3 months
With informed concent
Key exclusion criteria
Fever up more than 38 degree
Severe neurologic impairment or mental disorder
With severe other organ disorder
Without another malignant disease
Pregnant or lactating women
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Nagoya University
Division name
Hospital Department of Endoscopy
Zip code
466-8550
Address
65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
0527442166
h-kawa@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
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
0527442166
Homepage URL
h-kawa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital IRB
Address
65 Tsuruma-cho, Showa-ku, Nagoya 466-8550, Japan
Tel
052-744-2602
ethics@med.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
| 2017 | Year | 02 | Month | 01 | 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
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
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 09 | Day |
Last modified on
| 2023 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029442
