UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047820 |
|---|---|
| Receipt number | R000054515 |
| Scientific Title | Randomized clinical trial comparing treatment outcomes including adverse events of preoperative drainage for acute cholecystitis with endoscopic ultrasound and percutaneous transhepatic approach |
| Date of disclosure of the study information | 2022/05/23 |
| Last modified on | 2022/05/21 12:18:02 |
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Basic information
Public title
Randomized clinical trial comparing treatment outcomes including adverse events of preoperative drainage for acute cholecystitis with endoscopic ultrasound and percutaneous transhepatic approach
Acronym
RCT comparing the outcomes of endoscopic ultrasound versus percutaneous transhepatic drainage as a preoperative drainage method for acute cholecystitis
Scientific Title
Randomized clinical trial comparing treatment outcomes including adverse events of preoperative drainage for acute cholecystitis with endoscopic ultrasound and percutaneous transhepatic approach
Scientific Title:Acronym
RCT comparing the outcomes of endoscopic ultrasound versus percutaneous transhepatic drainage as a preoperative drainage method for acute cholecystitis
Region
| Japan |
Condition
Condition
acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the outcomes of treatment and the effect on surgical of EUS-GBD and PTGBD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
early adverse events
Key secondary outcomes
success rate of procedure,clinical efficacy improvement rate,procedure time, hospitalization duration,waiting time for surgery, surgical outcomes (blood loss, operative time, intraoperative adverse events,conversion rate to laparotomy),medical costs (from post-drainage to discharge date), patient QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Maneuver |
Interventions/Control_1
EUS-GBD
Interventions/Control_2
PTGBD
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with acute cholecystitis who are hospitalized at this hospital
Age at the time of enrollment was between 20 and 90 years old
Written consent for participation in the study has been obtained from the patients.
Patients scheduled to undergo LC within 2 months after drainage.
ECOG (Eastern Cooperative Oncology Group) performance status 0-3
Key exclusion criteria
Cases of postoperative reconstructed intestinal tract
Cases with ascites on the liver surface
Cases with difficulty to correct bleeding tendency or coagulation abnormality
Poor gallbladder delineation and difficulty in securing the puncture route
Cases with serious complications in other organs: ASA classification 3 or higher (excluding dialysis patients)
ECOG performance status 4 (see Appendix #2)
Cases with poor general condition and life expectancy judged to be less than 3 months
Cases in which informed consent cannot be obtained
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical and Pharmaceutical University
Division name
2nd depaetment of internal medicine
Zip code
5690801
Address
2-7, Daigakumachi, Takatsuki City, Osaka
TEL
0726831221
oguratakeshi0411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Okuda |
Organization
Osaka Medical and Pharmaceutical University
Division name
2nd depaetment of internal medicine
Zip code
5690801
Address
2-7, Daigakumachi, Takatsuki City, Osaka
TEL
0726831221
Homepage URL
ubuntu_koromo@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Osaka Medical and Pharmaceutical University Research Ethics Committee
Address
2-7, Daigakumachi, Takatsuki City, Osaka
Tel
0726831221
rinri@ompu.ac.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
| 2022 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 21 | Day |
Last modified on
| 2022 | 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=R000054515
