UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021261
Receipt number R000024524
Scientific Title Usefulness of Non-flared Intraductal Fully Covered Metallic Stent for Refractory Biliary Strictures after Living Donor Liver Transplantation
Date of disclosure of the study information 2016/03/01
Last modified on 2022/03/15 21:01:43

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Basic information

Public title

Usefulness of Non-flared Intraductal Fully Covered Metallic Stent for Refractory Biliary Strictures after Living Donor Liver Transplantation

Acronym

Metal stenting for biliary strictures after liver transplantation

Scientific Title

Usefulness of Non-flared Intraductal Fully Covered Metallic Stent for Refractory Biliary Strictures after Living Donor Liver Transplantation

Scientific Title:Acronym

Metal stenting for biliary strictures after liver transplantation

Region

Asia(except Japan)


Condition

Condition

Benign biliary stricture after liver transplantation

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness of intraductal placement of non-flared fully covered self-expandable metallic stent for refractory biliary stricture after living donor liver transplantation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Stricture resolution: significant increase the diameter of stricture site and complete runoff of contrast after stent 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

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

metal stenting for 3 months

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

18 years-old <

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Clinical symptoms of bile duct obstruction with jaundice
2. Documented benign biliary stricture after living donor liver transplantation
3. Refractory to balloon dilation and plastic stenting

Key exclusion criteria

1. Documented malignant bile duct stricture
2. Multiple strictures of the bile duct
3. Surgically altered gastrointestinal anatomy
4. Bleeding tendency or any contraindications for ERCP

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Jong Ho
Middle name
Last name Moon

Organization

SoonChunHyang University School of Medicine

Division name

Digestive Disease Center and Research Institute, Department of Internal Medicine

Zip code

14584

Address

170 Jomaru-ro, Wonmi-gu, Bucheon

TEL

+82-32-621-5094

Email

jhmoon@schmc.ac.kr


Public contact

Name of contact person

1st name Hyun Jong
Middle name
Last name Choi

Organization

SoonChunHyang University School of Medicine

Division name

Digestive Disease Center and Research Institute, Department of Internal Medicine

Zip code

14584

Address

170 Jomaru-ro, Wonmi-gu, Bucheon

TEL

+82-32-621-5211

Homepage URL


Email

joseph@schmc.ac.kr


Sponsor or person

Institute

SoonChunHyang University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

No specific funding source

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

SoonChunHyang University Bucheon Hospital Institutional Review Board

Address

170 Jomaru-ro, Wonmi-gu, Bucheon

Tel

+82-32-621-6362

Email

irb@schmc.ac.kr


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

2016 Year 03 Month 01 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/31418477/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/31418477/

Number of participants that the trial has enrolled

32

Results

Technical and clinical success rates of intraductal placement with FCSEMS were 100% (32/32) and 81.2% (26/32), respectively. Intended stent removal was successful in 27 (100%) patients (median, 101 days; range, 23-118 days).

Results date posted

2022 Year 03 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Male 26 (81.3)Female 6 (18.7)
Indications for living donor liver transplantation
Hepatocellular carcinoma 12 (37.4)
Viral liver cirrhosis 10 (31.3)
Alcoholic liver cirrhosis 6 (18.8)
Primary biliary cholangitis 4 (12.5)
Type of stricture
Anastomotic 31 (96.9)
Non-anastomotic 1 (3.1)
Location of stricture, number (percent)
Common hepatic duct 22 (68.8)
Hilum 8 (25.0)
Common bile duct 2 (6.2)

Participant flow

A total of 32 consecutive patients with symptomatic ABS after LDLT unresolved by plastic stents with or without balloon dilation at four tertiary medical centers were prospectively enrolled. A short (3 or 5 cm) FCSEMS having long lasso (10 cm) used in this study had unflared convex ends to minimize tissue hyperplasia and smaller center portion to prevent migration. The FCSEMS was placed above the papilla and removed at 3-4 months after stenting.

Adverse events

Early stent migration was observed in five (15.6%) patients. However, three patients with early stent migration had stricture resolution without needing additional intervention. No stent-induced ductal change was observed in all patients. Stricture recurrence was observed in 11.5% (3/26) of patients during 639 days of median duration of follow-up (range, 366-2079 days).

Outcome measures

Technical and clinical success rates of intraductal placement with FCSEMS were 100% (32/32) and 81.2% (26/32), respectively. Intended stent removal was successful in 27 (100%) patients (median, 101 days; range, 23-118 days).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 01 Month 01 Day

Date of IRB

2013 Year 01 Month 01 Day

Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2017 Year 01 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 03 Month 01 Day

Last modified on

2022 Year 03 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024524


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name