UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture.
Acronym	Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture.
Scientific Title	Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture.
Scientific Title:Acronym	Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture.
Region	Japan

Condition
Condition	Benign biliary stricture and benign pancreatic stricture
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A standard therapeutic strategy for benign biliary stricture or benign pancreatic stricture is indwelling multiple plastic stents and scheduled stent exchange. A disadvantage of this therapy is that patients have to receive several sessions of ERCP, and there exist some refractory cases who repeat stent exchange for a long time. The objective of present study is to evaluate the rate of stricture resolution and the safety of newly designed covered metallic stent for benign biliary and pancreatic strictures.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of stricture resolution at stent removal after 90 days of indwelling.
Key secondary outcomes	1.Overall rate of stricture resolution at the end of the study period. 2.Rate of stricture recurrence and period until stricture recurrence. 3.Success rate of stent removal. 4.Adverse event at stent removal. 5.Other adverse events.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Insert a covered self-expandable metallic stent with a removal string (Niti-S Kaffes stent, Taewoong medical, Korea) into benign biliary and pancreatic stricture for 90 days.
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. Benign biliary stricture and benign pancreatic stricture (post-operative biliary stricture, post-liver transplantation bilio-biliary anastomotic stricture, biliary stricture by chronic pancreatitis, pancreatic stricture by chroninc pancreatitis, anastomotic stricture after choledochojejunostomy, and anastomotic stricture after pancreaticojejunostomy). 2. Patients with refractory stricture. (Stricture resolution was not achieved after 6 months of treatment by plastic stent insertion or PTBD insertion). 3. Malignant biliary or pancreatic stricture is ruled out by pathological examination and clinical course. 4. Patients with written informed consent.
Key exclusion criteria	1. Patients with difficulty in endoscopic approach to strictures. 2. Patients withpossibility of malignant biliary or pancreatic stricture. 3. Patients with performance status 3-4. 4. Patients with serious concomitant diseases such as heart failure, respiratory failure, or disturbance of consciousness and who cannot tolerate endoscopic procedures. 5. Patients considered ineligible by the attending physician.
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Yousuke Middle name Last name Yousuke
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology
Zip code	113-8655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	ynakai-tky@umin.ac.jp

Public contact
1st name of contact person	1st name Tatsuya Middle name Last name Tatsuya
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology
Zip code	113-8655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	tatsusatou-tky@umin.org

Sponsor
Institute	Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
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	The University of Tokyo, Clinical research support center
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel	03-5800-8743
Email	crctky-office@umin.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	東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 15 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	30
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	Completed
Date of protocol fixation	2016 Year 06 Month 01 Day
Date of IRB	2016 Year 05 Month 23 Day
Anticipated trial start date	2016 Year 07 Month 15 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 05 Month 01 Day
Last modified on	2019 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025539