UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001775 |
|---|---|
| Receipt number | 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 17:16:10 |
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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
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
Sponsor or person
Institute
Asan Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002137
