UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046530
Receipt No. R000052516
Scientific Title Safety and efficacy of transpapillary biliary drainage using a long plastic stent for malignant distal biliary obstruction
Date of disclosure of the study information 2022/01/05
Last modified on 2022/01/04

* 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 Safety and efficacy of transpapillary biliary drainage using a long plastic stent for malignant distal biliary obstruction
Acronym Safety and efficacy of transpapillary biliary drainage using a long plastic stent for malignant distal biliary obstruction
Scientific Title Safety and efficacy of transpapillary biliary drainage using a long plastic stent for malignant distal biliary obstruction
Scientific Title:Acronym Safety and efficacy of transpapillary biliary drainage using a long plastic stent for malignant distal biliary obstruction
Region
Japan

Condition
Condition Patients with distal biliary obstruction due to unresectable malignant tumor
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy of transpapillary biliary drainage using a long plastic stent
Basic objectives2 Safety,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 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 Based on the length required to position the tip in the duodenojejunal flexure on fluoroscopic imaging, a 7.5Fr endoscopic nasobiliary drainage tube is cut.
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 20 years and more
Distal biliary obstruction due to unresectable malignant tumor, and biliary stenting is planned.
Key exclusion criteria Surgically altered anatomy
Proximal biliary stricture
Performance status score of 4,
Serious complications in other organs (ASA category 3 and more)
Life expectancy less than 3 months.
Target sample size 23

Research contact person
Name of lead principal investigator
1st name Koichiro
Middle name
Last name Mandai
Organization Kyoto Second Red Cross Hospital
Division name Gastroenterology
Zip code 602-8026
Address 355-5 Haruobi-cho, Kamigyo-ku, Kyoto city
TEL 0752315171
Email mndkchr@gmail.com

Public contact
Name of contact person
1st name Koichiro
Middle name
Last name Mandai
Organization Kyoto Second Red Cross Hospital
Division name Gastroenterology
Zip code 602-8026
Address 355-5, Haruobi-cho, Kamigyo-ku, Kyoto city
TEL 0752315171
Homepage URL
Email mndkchr@gmail.com

Sponsor
Institute Kyoto Second Red Cross Hospital
Institute
Department

Funding Source
Organization Kyoto Second Red Cross 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 Institutional review board (Kyoto Second Red Cross Hospital)
Address 355-5, Haruobi-cho, Kamigyo-ku, Kyoto city
Tel 0752315171
Email chiken2@kyoto2.jrc.or.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 01 Month 05 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
2021 Year 09 Month 27 Day
Date of IRB
2021 Year 11 Month 04 Day
Anticipated trial start date
2022 Year 01 Month 04 Day
Last follow-up date
2024 Year 07 Month 03 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 01 Month 04 Day
Last modified on
2022 Year 01 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052516

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.