UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047745
Receipt number R000054430
Scientific Title Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Liver Transplantation
Date of disclosure of the study information 2022/05/13
Last modified on 2023/11/15 18:22:12

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Basic information

Public title

Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Liver Transplantation

Acronym

Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Liver Transplantation

Scientific Title

Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Liver Transplantation

Scientific Title:Acronym

Efficacy of Metallic Stent for Treatment of Anastomotic Biliary Stricture After Liver Transplantation

Region

Japan


Condition

Condition

Anastomotic Biliary Stricture After Liver Transplantation

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze the efficacy of covered self-expandable metallic stent (cSEMS) for patients with anastomotic biliary stricture after liver transplantation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Stricture resolution rate after cSEMS removal

Key secondary outcomes



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

cSEMS placement

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.patients with anastomotic biliary stricture who had duct- to-duct anastomosis after liver transplantation

Key exclusion criteria

1.Patients who can not receive endoscopic treatment 2.Patient with severe blood coagulation disorder 3.Patients with biliary stricture due to benign tumors 4.Patients who may have sensitization or allergic reactions to nitinol products
5.Patients who are pregnant or are likely to be pregnant, n ursing patients, and patients who wish to be pregnant duri ng the study period
6.In addition, patients who the research director has judge d inappropriate as a research subject

Target sample size

18


Research contact person

Name of lead principal investigator

1st name Kosuke
Middle name
Last name Takahashi

Organization

Nagasaki University Hospital

Division name

Department of Gatroenterology and Hepatology

Zip code

852-8501

Address

1-7-1, Sakamoto Nagasaki

TEL

095-819-7481

Email

takapochi0809@gmail.com


Public contact

Name of contact person

1st name Kosuke
Middle name
Last name Takahashi

Organization

Nagasaki University Hospital

Division name

Department of Gatroenterology and Hepatology

Zip code

852-8501

Address

1-7-1, Sakamoto Nagasaki

TEL

095-819-7481

Homepage URL


Email

takapochi0809@gmail.com


Sponsor or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



Funding Source

Organization

Nagasaki University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Hospital Institutional Review Board

Address

1-7-1, Sakamoto Nagasaki

Tel

0958197229

Email

gaibushikin@ml.nagasaki-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

2022 Year 05 Month 13 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

2022 Year 04 Month 18 Day

Date of IRB

2022 Year 05 Month 24 Day

Anticipated trial start date

2022 Year 07 Month 01 Day

Last follow-up date

2027 Year 12 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

2022 Year 05 Month 12 Day

Last modified on

2023 Year 11 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054430


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name