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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012316
Receipt No. 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

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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
Email 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
Email itoi@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014271

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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