UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007061 |
|---|---|
| Receipt number | R000008320 |
| Scientific Title | A pilot study of new covered metallic stent with large bore size for the unresectable distal biliary malignancies: Niti-S SUPREMO-12 |
| Date of disclosure of the study information | 2012/01/13 |
| Last modified on | 2016/05/26 01:51:37 |
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Basic information
Public title
A pilot study of new covered metallic stent with large bore size for the unresectable distal biliary malignancies: Niti-S SUPREMO-12
Acronym
A pilot study of new covered metallic stent with large bore size for the unresectable distal biliary malignancies: Niti-S SUPREMO-12 (NEWCOMER 12)
Scientific Title
A pilot study of new covered metallic stent with large bore size for the unresectable distal biliary malignancies: Niti-S SUPREMO-12
Scientific Title:Acronym
A pilot study of new covered metallic stent with large bore size for the unresectable distal biliary malignancies: Niti-S SUPREMO-12 (NEWCOMER 12)
Region
| Japan |
Condition
Condition
unresectable distal biliary malignancy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the patency and safety of a Niti-S SUPREMO-12 stent for unresectable distal biliary malignancy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
1) Stent occlusion rate and dysfunction rate
2) Stent patency duration
3) Time to dysfunction
4) Overall stent patency rate and function rate
Key secondary outcomes
1) Median survival time
2) Stent-related complication rate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with unresectable distal malignant biliary obstruction
2) Prognosis is expected more than 2 months.
3) Written informed consent is obtained.
4) Performance status is grade 2 or smaller
Key exclusion criteria
1) Patients with massive ascites
2) Patients with serious problem in any other organs
3) Patients whose stricture extends to hilar bile duct
4) Patients with Inaccessible to the duodenal papilla (ex. total gastrectomy)
5) Contraindications of endoscopic procedure
6) Patients with intestinal obstruction in the distal to the ampulla
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Mukai |
Organization
Gifu Municipal Hospital
Division name
Department of Gastroenterology
Zip code
Address
7-1 Kashima-cho, Gifu, Gifu, Japan
TEL
058-251-1101
tsuyomukai@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Mukai |
Organization
Gifu Municipal Hospital
Division name
Department of Gastroenterology
Zip code
Address
7-1 Kashima-cho, Gifu, Gifu, Japan
TEL
058-251-1101
Homepage URL
http://mc16.medicalstream.net/cgi-bin/auth/login.cgi
tsuyomukai@yahoo.co.jp
Sponsor or person
Institute
NEWCOMER12 study group
Institute
Department
Personal name
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
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
岐阜市民病院（岐阜県）/ Gifu Municipal Hospital (Gifu)
東京大学医学部附属病院（東京都）/ University of Tokyo Hospital (Tokyo)
岐阜大学医学部附属病院（岐阜県）/ Gifu University Hospital (Gifu)
東京医科大学（東京都）/ Tokyo Medical University (Tokyo)
北海道大学（北海道）/ Hokkaido University Graduate School of Medicine (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 13 | Day |
Related information
URL releasing protocol
http://gmhosp.jp/images/pdf/b9.pdf
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26927207
Number of participants that the trial has enrolled
Results
RESULTS: The technical and functional success rates of the procedures were 100%. The 6-month non-RBO rate was 50%, and the median time to RBO was 184 days. The median survival time was 241 days. Twelve patients died within 6 months after stent placement without RBO. RBO was observed in 10 patients (26%), with 7 experiencing stent occlusion and 3 experiencing stent migration. Adverse events other than RBO (at < 30 days) developed in 6 patients (16%; cholecystitis, 1; pancreatitis, 1; hyperamylasemia, 1; pancreatic ductitis, 1; abdominal pain, 2). Stent removal for reintervention was successfully completed in 8 patients.
CONCLUSIONS: Our novel FCSEMS may be safe and effective for managing malignant distal obstructions with an acceptable incidence of adverse events.
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
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
A follow-up period is the time from stent placement to patient death or stent occlusion.
Management information
Registered date
| 2012 | Year | 01 | Month | 12 | Day |
Last modified on
| 2016 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008320
