UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032660 |
|---|---|
| Receipt number | 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 | 2020/05/21 09:48:03 |
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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
Oita San-ai Medical Center
Division name
Department of Gastroenterology
Zip code
870-1151
Address
1213, Oaza Ichi, Oita, Oita 870-1151, Japan.
TEL
+81-97-541-1311
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Oita San-ai Medical Center
Division name
Department of Gastroenterology
Zip code
870-1151
Address
1213, Oaza Ichi, Oita, Oita 870-1151, Japan.
TEL
+81-97-541-1311
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
Oita San-ai Medical Center
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
Oita San-ai Medical Center
Address
1213, Oaza Ichi, Oita, Oita 870-1151, Japan.
Tel
+81-97-541-1311
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
| 2020 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036998
