UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial on efficacy of metal stents vs. inside plastic stents for unresectable malignant obstruction of the perihilar bile duct
Acronym	MiPS study
Scientific Title	Randomized controlled trial on efficacy of metal stents vs. inside plastic stents for unresectable malignant obstruction of the perihilar bile duct
Scientific Title:Acronym	MiPS study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of placement of inside plastic stents (PSs)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patency period of inside PSs
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Deployment of inside PSs
Interventions/Control_2	Deployment of metal stents (MSs)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	a. those who have been diagnosed as malignant perihilar biliary obstruction with Bismuth level 2 or more. b. Clinically non resectable c. Total biliarubin =/> 2.0 mg/dL d. No history of previous biliary stent placement e. Expected prognosis > 3 months f. Obtaining written informed concent
Key exclusion criteria	a. No tolerance of endoscopic procedures b. ASA class 4 or more c. Reconstructed upper GI tract d. State after papillectomy, surgical biliojejunostomy e. Planned for surgical resection, radiotherapy, PDT, or HIFU f. Planned for scheduled replacement of PSs g. State after placement of irremoval biliary stents h. Tumors extending to lower bile duct i. Tumors which have already invaded to broad area and which was considered to be difficult to treat with biliary drainage j. Tumors with papillary growth k. Active infectious inflammation l. PSC, IgG4-SC and PBC m. LC stage Child-Pugh C n. Hemolyzing disease o. Allergic for contrast
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Yoshihide Middle name Last name Kanno
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
Zip code	9810913
Address	5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
TEL	022-252-1111
Email	yoshi-hk@openhp.or.jp

Public contact
Name of contact person	1st name Yoshihide Middle name Last name Kanno
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
Zip code	981-0913
Address	5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
TEL	022-252-1111
Homepage URL
Email	yoshi-hk@openhp.or.jp

Sponsor
Institute	Sendai City Medical Center
Institute
Department

Funding Source
Organization	Sendai City Medical Center
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	Institutional Review Board of Sendai City Medical Center
Address	Tsurugaya 5-22-1, Miyagino-ku, Sendai, Miyagi, Japan
Tel	0222521111
Email	yoshihk44@yahoo.co.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 02 Month 24 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	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 20 Day
Date of IRB	2017 Year 03 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 20 Day
Last modified on	2020 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029636