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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045690
Receipt No. R000052147
Scientific Title Efficacy of double-balloon enteroscopy-assisted fully-covered metal stent deployment for hepaticojejunostomy anastomotic stricture
Date of disclosure of the study information 2021/11/30
Last modified on 2021/10/09

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Basic information
Public title Efficacy of double-balloon enteroscopy-assisted fully-covered metal stent deployment for hepaticojejunostomy anastomotic stricture
Acronym Efficacy of double-balloon enteroscopy-assisted fully-covered metal stent deployment for hepaticojejunostomy anastomotic stricture
Scientific Title Efficacy of double-balloon enteroscopy-assisted fully-covered metal stent deployment for hepaticojejunostomy anastomotic stricture
Scientific Title:Acronym Efficacy of double-balloon enteroscopy-assisted fully-covered metal stent deployment for hepaticojejunostomy anastomotic stricture
Region
Japan

Condition
Condition hepaticojejunostomy anastomotic stricture
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will examine the safety and effectiveness of a metal stent for patient with an primary and recurrent hepaticojejunostomy anastomotic stricture.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The outcome investigated is patency rate of hepaticojejunostomy anastomosis until 1-year after removal of metal stent.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 The inclusion criteria were primary and recurrent hepaticojejunostomy anastomotic strictures, coupled with related signs (elevation of serum hepatobiliary enzymes with dilatation of the intrahepatic bile duct detected by abdominal ultrasonography or radiological studies, or fever). Hepaticojejunostomy anastomotic strictures was defined as a waist in the area of Hepaticojejunostomy anastomosis detected using cholangiography and endoscopic imaging.
Key exclusion criteria (1)Patients with intrahepatic bile duct stenosis.
(2)A score of 4 or 5 according to the Eastern Cooperative Oncology Group Performance Status.
(3)Severe complications in other organs.
(4)Patients who underwent liver transplantation.
(5)Suspected malignant biliary stricture.
(6)Age younger than 20 years.
(7)Patient with severe blood coagulation disorder.
(8)Inability to provide written informed consent.
Target sample size 146

Research contact person
Name of lead principal investigator
1st name Hironari
Middle name
Last name Kato
Organization Okayama University Hospital
Division name Gastroenterology and Hepatology
Zip code 700-8558
Address 5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL 086-235-7219
Email katou-h@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Fujii
Organization Okayama University Hospital
Division name Gastroenterology and Hepatology
Zip code 700-8558
Address 5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL 086-235-7219
Homepage URL
Email y_f1105@yahoo.co.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization none
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 Okayama University Hospital
Address 5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
Tel 086-235-7219
Email y_f1105@yahoo.co.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
2021 Year 11 Month 30 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
2021 Year 10 Month 06 Day
Date of IRB
Anticipated trial start date
2021 Year 11 Month 30 Day
Last follow-up date
2025 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (1) Stricture resolution rate at the time of metal stent removal.
(2)Technical success rate.
(3)Rate of removal of metal stent.
(4)Rate of recurrence of the anastomotic stricture.
(5)Rate of adverse events.

Management information
Registered date
2021 Year 10 Month 06 Day
Last modified on
2021 Year 10 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052147

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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