UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035646 |
|---|---|
| Receipt number | R000040606 |
| Scientific Title | A new endoscopic transpapillary gallbladder drainage technique combined with intraductal ultrasonography for patients with acute cholecystitis. |
| Date of disclosure of the study information | 2019/01/23 |
| Last modified on | 2019/01/23 19:09:41 |
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Basic information
Public title
A new endoscopic transpapillary gallbladder drainage technique combined with intraductal ultrasonography for patients with acute cholecystitis.
Acronym
transpapillary gallbladder drainage technique combined with intraductal ultrasonography
Scientific Title
A new endoscopic transpapillary gallbladder drainage technique combined with intraductal ultrasonography for patients with acute cholecystitis.
Scientific Title:Acronym
transpapillary gallbladder drainage technique combined with intraductal ultrasonography
Region
| Japan |
Condition
Condition
acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of endoscopic transpapillary gallbladder drainage with intraductal ultrasound.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success of endoscopic transpapillary gallbladder drainage.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform endoscopic transpapillary gallbladder drainage combined with intraductal ultrasound.
Interventions/Control_2
Perform endoscopic transpapillary gallbladder drainage combined without intraductal ultrasound.
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 that must be perforemed drainage.
Key exclusion criteria
patients with common bile duct stone before gallbladder drainage
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryota Sagami |
Organization
New Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
1271 Wanagaya, Matsudo Chiba, Japan
TEL
0477118700
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryota Sagami |
Organization
New Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
99
Org. issuing International ID_1
New Tokyo Hospital Institutional Review Board number 99
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
新東京病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 23 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2019 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040606
