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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032660
Receipt No. R000036998
Scientific Title Utility of emergency endoscopic drainage for patient with antithrombotic therapy.
Date of disclosure of the study information 2018/05/21
Last modified on 2019/03/30

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Basic information
Public title Utility of emergency endoscopic drainage for patient with antithrombotic therapy.
Acronym Endoscopic drainage for patient with antithrombotic therapy.
Scientific Title Utility of emergency endoscopic drainage for patient with antithrombotic therapy.
Scientific Title:Acronym Endoscopic drainage for patient with antithrombotic therapy.
Region
Japan

Condition
Condition Patients with operable acute cholecystitis during antithrombotic therapy.
Patients with inoperable acute cholecystitis accompany with common bile duct stone.
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the appropriate endoscopic treatment: ETGBD and EUS-GBD for patients with acute cholecystitis who have no indication for emergency surgery because of antithrombotic therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficiency of ETGBD
Efficiency of EUS-GBD for patients who ETGBD was unsuccessful.
Disappearance of abdominal pain
Normalization of white blood cell count
Improvement of C-reactive protein value
Key secondary outcomes Procedure success rate
Treatment time
Complication rate
Recurrence rate of cholecystitis

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 Treatment of ETGBD for patients with acute cholecystitis. In case of failure, PTGBD or EUS-GBD is alternatively performed.
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 Patients with acute cholecystitis requiring elective emergency drainage is necessary.
Patients who are not indicated for surgery or PTGBD due to poor general condition, oral antithrombotic drugs, elderly, etc.
Those are able to follow until cholecystectomy or inoperable.
Key exclusion criteria Patients with multiple organ dysfunction
Patients with common bile duct stones
Pregnant, Female patient with potential for pregnancy or lactating

Target sample size 100

Research contact person
Name of lead principal investigator
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
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
2018 Year 05 Month 21 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
2018 Year 04 Month 30 Day
Date of IRB
2018 Year 04 Month 30 Day
Anticipated trial start date
2018 Year 04 Month 30 Day
Last follow-up date
2022 Year 03 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
2018 Year 05 Month 21 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=R000036998

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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