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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009680
Receipt No. R000011352
Scientific Title Endoscopic indwelling gallbladder drainage (EIGBD) with a trimmed nasobiliary tube for acute cholecystitis: a prospective pilot study
Date of disclosure of the study information 2013/01/05
Last modified on 2017/03/19

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Basic information
Public title Endoscopic indwelling gallbladder drainage (EIGBD) with a trimmed nasobiliary tube for acute cholecystitis: a prospective pilot study
Acronym BLADE Study
Scientific Title Endoscopic indwelling gallbladder drainage (EIGBD) with a trimmed nasobiliary tube for acute cholecystitis: a prospective pilot study
Scientific Title:Acronym BLADE Study
Region
Japan

Condition
Condition Acute cholecystitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of stenting using trimmed nasobiliary drainage tube for acute cholecystitis scheduled to elective cholecystectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Technical success rate
Clinical success rate
Key secondary outcomes Length of procedure
Incidence of complication
Duration of hospital stay

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
Maneuver
Interventions/Control_1 Therapeutic ERCP
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.Moderate acute cholecystitis, diagnosed according to the Tokyo guidelines 2007 criteria.
2.Patients with tolerable for elective surgery.
3.Performance status 0-3.
Key exclusion criteria 1.age <20 years.
2.PS 4
3.Patients with surgical altered anatomy such as Billroth II or Roux-en-Y anastomosis.
4.Possible or current pregnancy.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Yasuda
Organization Teikyo University MIzonokuchi Hospital
Division name Dept. of Gastroenterology
Zip code
Address 3-8-3, Mizokuchi, Takatsu-ku, Kawasaki city, Kanagawa pref., Japan
TEL 044-844-3333
Email sinpesan@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shinpei Doi
Organization Teikyo University MIzonokuchi Hospital
Division name Dept. of Gastroenterology
Zip code
Address 3-8-3, Mizokuchi, Takatsu-ku, Kawasaki city, Kanagawa pref., Japan
TEL 044-844-3333
Homepage URL
Email sinpesan@gmail.com

Sponsor
Institute Teikyo University MIzonokuchi Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor 1) Gifu Municipal Hospital
2) Gifu Prefectural Medical Center
3) Gifu University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 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 Completed
Date of protocol fixation
2013 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 13 Day
Last follow-up date
2015 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
2013 Year 01 Month 02 Day
Last modified on
2017 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011352

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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