UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036057 |
|---|---|
| Receipt number | 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 16:24:46 |
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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
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
sagami1985@yahoo.co.jp
Sponsor or person
Institute
New Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041071
