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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001775
Receipt No. R000002137
Scientific Title One Step EUS-guided Cholecystoenterostomy in High Risk Patients
Date of disclosure of the study information 2009/04/30
Last modified on 2009/03/15

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Basic information
Public title One Step EUS-guided Cholecystoenterostomy in High Risk Patients
Acronym One Step EUS-guided Cholecystoenterostomy in High Risk Patients; Simple and Modified technique
Scientific Title One Step EUS-guided Cholecystoenterostomy in High Risk Patients
Scientific Title:Acronym One Step EUS-guided Cholecystoenterostomy in High Risk Patients; Simple and Modified technique
Region
Asia(except Japan)

Condition
Condition Patients who are diagnosed with acute cholecystitis unresponsive to conservative management and poor candidate for surgery
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the technical feasibility, efficacy, and safety of modified EUS-guided cholecystoenterostomy in patients with high surgical risk or malignant disease of advanced stage.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Clinical resolution of acute cholecystitis
Key secondary outcomes Technical success and procedure related complications

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
Device,equipment Maneuver
Interventions/Control_1 Simple modified EUS-guided cholecystoenterostomy
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
18 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1. Patient over 18 years old
2. Patient with acute cholecystitis
3. Patient with severe debilitating co-morbidity
4. Patient with terminal malignant disease
Key exclusion criteria 1. No written informed consent
2. Patient with uncorrectable severe coagulopathy


Target sample size 7

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Do Hyun Park
Organization Asan Medical Center
Division name Departments of Gastroenterology
Zip code
Address 388-1 Pungnap-dong, Songpa-gu, Seoul 138-736, Korea
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tae Jun Song
Organization Asan Medical Center
Division name Departments of Gastroenterology
Zip code
Address 388-1 Pungnap-dong, Songpa-gu, Seoul 138-736, Korea
TEL
Homepage URL
Email

Sponsor
Institute Asan Medical Center
Institute
Department

Funding Source
Organization Asan Medical Center
Organization
Division
Category of Funding Organization Self funding
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 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
2009 Year 04 Month 30 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 Terminated
Date of protocol fixation
2008 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2009 Year 02 Month 01 Day
Date of closure to data entry
2009 Year 02 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 15 Day
Last modified on
2009 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002137

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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