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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035646
Receipt No. R000040606
Scientific Title A new endoscopic transpapillary gallbladder drainage technique combined with intraductal ultrasonography for patients with acute cholecystitis.
Date of disclosure of the study information 2019/01/23
Last modified on 2019/01/23

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Basic information
Public title A new endoscopic transpapillary gallbladder drainage technique combined with intraductal ultrasonography for patients with acute cholecystitis.
Acronym transpapillary gallbladder drainage technique combined with intraductal ultrasonography
Scientific Title A new endoscopic transpapillary gallbladder drainage technique combined with intraductal ultrasonography for patients with acute cholecystitis.
Scientific Title:Acronym transpapillary gallbladder drainage technique combined with intraductal ultrasonography
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of endoscopic transpapillary gallbladder drainage with intraductal ultrasound.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Success of endoscopic transpapillary gallbladder drainage.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-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
Interventions/Control_1 Perform endoscopic transpapillary gallbladder drainage combined with intraductal ultrasound.
Interventions/Control_2 Perform endoscopic transpapillary gallbladder drainage combined without intraductal ultrasound.
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
98 years-old >=
Gender Male and Female
Key inclusion criteria patients with acute cholecystitis that must be perforemed drainage.
Key exclusion criteria patients with common bile duct stone before gallbladder drainage
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryota Sagami
Organization New Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address 1271 Wanagaya, Matsudo Chiba, Japan
TEL 0477118700
Email sagami1985@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryota Sagami
Organization New Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address 1271 Wanagaya, Matsudo Chiba, Japan
TEL 0477118700
Homepage URL
Email sagami1985@yahoo.co.jp

Sponsor
Institute New Tokyo Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 99
Org. issuing International ID_1 New Tokyo Hospital Institutional Review Board number 99
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 新東京病院

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 23 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
2014 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 01 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
2019 Year 01 Month 23 Day
Last modified on
2019 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040606

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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