UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012316 |
|---|---|
| Receipt number | R000014271 |
| Scientific Title | Comparative study between endoscopic nasogallbladder drainage (ENGBD) and endoscopic gallbladder stenting (EGBS) for acute cholecystitis: Prospective multi-center randomized trial |
| Date of disclosure of the study information | 2013/11/15 |
| Last modified on | 2014/12/15 19:24:42 |
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Basic information
Public title
Comparative study between endoscopic nasogallbladder drainage (ENGBD) and endoscopic gallbladder stenting (EGBS) for acute cholecystitis: Prospective multi-center randomized trial
Acronym
Endoscopic nasogallbladder drainage (ENGBD) vs endoscopic gallbladder stenting (EGBS) for acute cholecystitis
Scientific Title
Comparative study between endoscopic nasogallbladder drainage (ENGBD) and endoscopic gallbladder stenting (EGBS) for acute cholecystitis: Prospective multi-center randomized trial
Scientific Title:Acronym
Endoscopic nasogallbladder drainage (ENGBD) vs endoscopic gallbladder stenting (EGBS) for acute cholecystitis
Region
| Japan |
Condition
Condition
Acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively compare the efficacy between ENGBD and EGBS.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Successful rate of ENGBD or EGBS
Key secondary outcomes
Kinds and frequency of complications
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Gallbladder drainage (ENGBD)
Interventions/Control_2
Gallbladder drainage (EGBS)
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
Patients in whom gallbladder drainage are needed.
Patients consent to be included in the study based on his/her own free will after sufficient informing and understanding of the study.
Key exclusion criteria
1) Cases having difficulty in endoscopic approach
2) Cases in Performance status 4
3) Cases in Metaric sten placement
4) Cases with prior surgically altered anatomy without Billroth-I
5) Cases with sever complication in other organs
6) Cases without informed consent
7) Cases judged by principal investigator to be inadequate as subjects
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Itoi |
Organization
Tokyo Medical University
Division name
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
Zip code
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
itoi@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Itoi |
Organization
Tokyo Medical University
Division name
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
Zip code
Address
6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
itoi@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of the 4th Internal medicine (Gastroenterology and Hepatology)
Tokyo Medical University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ichiro Yasuda
Tadao Tsuji
Akio Katanuma
Teitetsu Niido
Atsushi Irisawa
Syomei Ryozawa
Hiroshi Kawakami
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
東京医科大学病院，岐阜大学医学部附属病院，さいたま市立病院，手稲渓仁会病院，戸田中央総合病院，福島県立医科大学付属病院，山口大学医学部附属病院，北海道大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 15 | 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
| 2012 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 15 | Day |
Last modified on
| 2014 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014271
