UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009680 |
|---|---|
| Receipt number | 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 01:41:09 |
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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
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
sinpesan@gmail.com
Sponsor or person
Institute
Teikyo University MIzonokuchi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011352
