UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study of new covered metallic stent with large bore size for the unresectable distal biliary malignancies: Niti-S SUPREMO-12
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Tsuyoshi Mukai
Organization	Gifu Municipal Hospital
Division name	Department of Gastroenterology
Address	7-1 Kashima-cho, Gifu, Gifu, Japan
TEL	058-251-1101
Email	tsuyomukai@yahoo.co.jp

Public contact
Name of contact person	Tsuyoshi Mukai
Organization	Gifu Municipal Hospital
Division name	Department of Gastroenterology
Address	7-1 Kashima-cho, Gifu, Gifu, Japan
TEL	058-251-1101
Homepage URL	http://mc16.medicalstream.net/cgi-bin/auth/login.cgi
Email	tsuyomukai@yahoo.co.jp

Sponsor
Institute	NEWCOMER12 study group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 01 Day
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

Related information
URL releasing protocol	http://gmhosp.jp/images/pdf/b9.pdf
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/26927207
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008320