UMIN-CTR Clinical Trial

Basic information
Public title	A novel metallic stent for unresectable distal malignant biliary obstruction; A multicenter prospective study
Acronym	EVOLUTION study
Scientific Title	A novel metallic stent for unresectable distal malignant biliary obstruction; A multicenter prospective study
Scientific Title:Acronym	EVOLUTION study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety and efficacy of novel full covered metal stent for unresectable malignant distal biliary obstruction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Stent patency
Key secondary outcomes	Technical success, Clinical success, Complications, Stent replaced, Survival period

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Full covered self expandable metal 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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients with unresectable malignant biliary stricture diagnosed by pathological findings. (2) Patients with written informed consent.
Key exclusion criteria	(1) Patients with uncontrolable jaundice or cholangitis after biliary drainage. (2) Patients with serious comorbidities. (3) Patients with ECOG performance status 4. (4) Patients with not expected prognosis more than 3 months. (5) Patients with hilar biliary stricture. (6) Patients with biliary reconstruction. (7) Patients with considered ineligible by the attending physician.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Atsuhiro Middle name Last name Masuda
Organization	Kobe University Graduate School of Medicine
Division name	Division of gastroenterology, Department of Internal medicine
Zip code	650-0017
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6305
Email	atmasuda@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Arata Middle name Last name Sakai
Organization	Kobe University Graduate School of Medicine
Division name	Division of gastroenterology, Department of Internal medicine
Zip code	650-0017
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6305
Homepage URL
Email	asakai@med.kobe-u.ac.jp

Sponsor
Institute	Division of gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Self funding
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	Kobe Univ. Hosp. clinical and translational research center
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel	078-382-6669
Email	kainyu@med.kobe-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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 17 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	73
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	No longer recruiting
Date of protocol fixation	2018 Year 01 Month 25 Day
Date of IRB	2018 Year 03 Month 07 Day
Anticipated trial start date	2018 Year 03 Month 16 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 11 Month 20 Day
Date analysis concluded	2022 Year 01 Month 24 Day

Other
Other related information

Management information
Registered date	2017 Year 11 Month 17 Day
Last modified on	2022 Year 05 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033002