UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022164
Receipt number R000025539
Scientific Title Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture.
Date of disclosure of the study information 2016/07/15
Last modified on 2019/05/04 23:13:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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

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 or person

Institute

Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025539


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name