UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037958
Receipt number R000043253
Scientific Title A prospective randomized control trial comparing newly designed 7mm double-bare metal stent and 7mm single-bare metal stent in patient with hilar malignant biliary strictures.
Date of disclosure of the study information 2019/10/01
Last modified on 2019/09/07 08:41:38

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Basic information

Public title

A prospective randomized control trial comparing newly designed 7mm double-bare metal stent and 7mm single-bare metal stent in patient with hilar malignant biliary strictures.

Acronym

A prospective randomized control trial comparing double-bare metal stent and single-bare metal stent in patient with hilar malignant biliary strictures.

Scientific Title

A prospective randomized control trial comparing newly designed 7mm double-bare metal stent and 7mm single-bare metal stent in patient with hilar malignant biliary strictures.

Scientific Title:Acronym

A prospective randomized control trial comparing double-bare metal stent and single-bare metal stent in patient with hilar malignant biliary strictures.

Region

Japan


Condition

Condition

Hilar malignant biliary obstruction

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and sefety of double bare metal stent for patient with unresectable malignant hilar biliary obstruction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time to Recurrent Biliary Obstruction

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

YES

Dynamic allocation

YES

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Placement of 7mm double bare metal stent by side by side method.

Interventions/Control_2

Placement of 7mm single bare metal stent by side by side method.

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 diagnosed as malignant hilar biliary obstruction of Bismuth classification II or higher by histopathology or diagnostic imaging such as CT and MRI
2) Patients with obstructive jaundice (Total billirubin> 2mg / dL) due to malignant hilar biliary obstruction at the first drainage
3) Patients who are over 20 years old when obtaining consent
4) Patients who have been diagnosed as clinically non-resectable
5) Patients who are expected to survive more than 3 months
6) Patients who have obtained their written informed consent to participate in the study

Key exclusion criteria

1) Patients who cannot receive endoscopic treatment due to general condition, jaw, oral cavity and digestive tract condition
2) Patients who have more than ASA Classification class 4(with severe life-threatening systemic disease) poor general condition or severe complications (severe congestive heart failure, severe coronary failure)
3) Patients after reconstruction of upper gastrointestinal tract other than Billroth-I reconstruction
4) Patients after excision of the duodenal papilla, after papilloplasty, and after surgical biliary anastomosis
5) Patients who are considering radical resection, radiation therapy, particle beam therapy, photodynamic therapy, high-intensity focused ultrasound
6) Patients whose periodic replacement of PS is considered desirable
7) Patients after biliary stent placement that cannot be removed
8) Patients whose endoscopic drainage is considered to be ineffective because of severely severe biliary branching due to huge intrahepatic cholangiocarcinoma or extensive cholangiocarcinoma
9) Patients who judge that uncovered MS placement should be avoided when tumor bleeding is severe, or when it is composed of a luminal growth type papillary tumor such as IPNB.
10) Patients with uncontrolled active infection other than acute cholangitis
11) Patients with primary sclerosing cholangitis, IgG4-related cholangitis, primary biliary cholangitis
12) Patients who have difficulty in determining the yellowing effect due to severe cirrhosis
13) Patients who have high total billirubin due to hemolytic disease and may not have obstructive jaundice
14) Patients with a history of allergy to biliary contrast media and severe allergies to angiographic media
15) Patients who are pregnant or may be pregnant
16) Patients whose follow-up is considered impossible at the study participating facility or related facilities that can be in close contact

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Irisawa

Organization

Dokkyo Medical University

Division name

Department of gastroenterology

Zip code

321-0293

Address

880, Kitakobayashi, Mibu, Shimotsuma, Tochigi

TEL

0282-86-1111

Email

irisawa@dokkyomed.ac.jp


Public contact

Name of contact person

1st name Kouhei
Middle name
Last name Tsuchida

Organization

Dokkyo Medical University

Division name

Department of gastroenterology

Zip code

321-0293

Address

880, Kitakobayashi, Mibu, Shimotsuma, Tochigi

TEL

0282-86-1111

Homepage URL


Email

tsuchida@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University

Institute

Department

Personal name



Funding Source

Organization

Non

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

Dokkyo Medical University

Address

880, Kitakobayashi, Mibu, Shimotsuma, Tochigi

Tel

0282-86-1111

Email

tsuchida@dokkyomed.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

2019 Year 10 Month 01 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

Preinitiation

Date of protocol fixation

2019 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2022 Year 07 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

2019 Year 09 Month 07 Day

Last modified on

2019 Year 09 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043253


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name