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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038209
Receipt No. R000043417
Scientific Title A multicenter prospective study of the incidence of cholecystitis after endoscopic biliary drainage using a novel low axial force covered self-expandable metallic stent in patients with unresectable malignant distal biliary obstruction
Date of disclosure of the study information 2019/11/01
Last modified on 2019/11/12

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Basic information
Public title A multicenter prospective study of the incidence of cholecystitis after endoscopic biliary drainage using a novel low axial force covered self-expandable metallic stent in patients with unresectable malignant distal biliary obstruction
Acronym A multicenter prospective study of the incidence of cholecystitis after EBD using a novel low axial force CSEMS in patients with unresectable malignant distal biliary obstruction
Scientific Title A multicenter prospective study of the incidence of cholecystitis after endoscopic biliary drainage using a novel low axial force covered self-expandable metallic stent in patients with unresectable malignant distal biliary obstruction
Scientific Title:Acronym A multicenter prospective study of the incidence of cholecystitis after EBD using a novel low axial force CSEMS in patients with unresectable malignant distal biliary obstruction
Region
Japan

Condition
Condition patients with unresectable malignant distal biliary obstruction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the incidence of cholecystitis after endoscopic biliary drainage using a novel low axial force CSEMS in patient with unresectable malignant distal biliary obstruction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence of cholecystitis
Key secondary outcomes technical success rate
functional success rate
time to recurrent biliary obstruction
adverse events

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 Maneuver
Interventions/Control_1 Endoscopic biliary drainage using a novel low axial force covered self-expandable metallic stent for malignant distal biliary obstruction.
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 1. age =>20
2. patients with malignant distal biliary obstruction (or stricture)
3. unresectable
4. providing written informed consent
Key exclusion criteria 1. after cholecystectomy
2. patients with malignant hilar biliary obstruction
3. after gastric surgery (excluding B-I method)
4. performance status 4
5. history of metal allergy
6. patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kosuke
Middle name
Last name Okuwaki
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374, Japan
TEL 81-42-778-8111
Email kokuwaki@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Minato
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374, Japan
TEL 81-42-778-8111
Homepage URL
Email mina0316@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
Department of Gastroenterology
Institute
Department

Funding Source
Organization no organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kitasato Medical Center Hospital
Isehara Kyodo Hospital
JCHO Sagamino Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kitasato University School of Medicine, Institutional Review Board
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374, Japan
Tel 81-42-778-8111
Email rinrib@med.kitasato-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 Kitasato University Hospital
Kitasato Medical Center Hospital
Isehara Kyodo Hospital
JCHO Sagamino Hospital

Other administrative information
Date of disclosure of the study information
2019 Year 11 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 Enrolling by invitation
Date of protocol fixation
2019 Year 09 Month 01 Day
Date of IRB
2019 Year 11 Month 06 Day
Anticipated trial start date
2020 Year 11 Month 12 Day
Last follow-up date
2022 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
2019 Year 10 Month 05 Day
Last modified on
2019 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043417

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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