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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036057
Receipt No. R000041071
Scientific Title The efficacy of endoscopic transpapillary gallbladder drainage for patients with acute cholecystitis under single and multi antithrombotic therapy.
Date of disclosure of the study information 2019/03/01
Last modified on 2019/03/30

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Basic information
Public title The efficacy of endoscopic transpapillary gallbladder drainage for patients with acute cholecystitis under single and multi antithrombotic therapy.
Acronym The efficacy of endoscopic transpapillary gallbladder drainage for patients under antithrombotic therapy.
Scientific Title The efficacy of endoscopic transpapillary gallbladder drainage for patients with acute cholecystitis under single and multi antithrombotic therapy.
Scientific Title:Acronym The efficacy of endoscopic transpapillary gallbladder drainage for patients under antithrombotic therapy.
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 ETGBD for patients with antithrombotic therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The severe bleeding complications that requires transfusion after the procedure.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
98 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with grade2,3 acute cholecystitis, or grade1 acute cholecystitis with severe inflammatory findings in blood test.
2. Patients who could not be treated by surgery or percutaneous transhepatic gallbladder drainage due to antithrombotic therapy.
3. Patients who agreed the treatment with informed consent before the procedure.
Key exclusion criteria 1. Patients with cholecystitis due to common bile duct stone.
2. The female patient during pregnancy.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Ryota
Middle name
Last name Ryota Sagami
Organization New Tokyo Hospital
Division name Department of Gastroenterology
Zip code 270-2232
Address 1271 Wanagaya, Matsudo, Chiba, Japan
TEL 0477118700
Email sagami1985@yahoo.co.jp

Public contact
Name of contact person
1st name Ryota
Middle name
Last name Sagami
Organization New Tokyo Hospital
Division name Department of Gastroenterology
Zip code 270-2232
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 New Tokyo Hospital
Address 1271 Wanagaya, Matsudo, Chiba, Japan
Tel 0477118700
Email sagami1985@yahoo.co.jp

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
2019 Year 03 Month 01 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 Open public recruiting
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
2019 Year 01 Month 25 Day
Anticipated trial start date
2019 Year 01 Month 25 Day
Last follow-up date
2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The procedures that were already performed are analized retrospectively.

Management information
Registered date
2019 Year 03 Month 01 Day
Last modified on
2019 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041071

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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