UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054582 |
|---|---|
| Receipt number | R000062370 |
| Scientific Title | Frequency and severity of postoperative bleeding after percutaneous transhepatic gallbladder drainage in patients with acute cholecystitis receiving continuous single antithrombotic drugs (A multicenter prospective study) |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/07/16 15:14:55 |
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Basic information
Public title
Frequency and severity of postoperative bleeding after percutaneous transhepatic gallbladder drainage in patients with acute cholecystitis receiving continuous single antithrombotic drugs (A multicenter prospective study)
Acronym
A multicenter prospective study of the impact of single antithrombotic drug continuation on postoperative bleeding after PTGBD
Scientific Title
Frequency and severity of postoperative bleeding after percutaneous transhepatic gallbladder drainage in patients with acute cholecystitis receiving continuous single antithrombotic drugs (A multicenter prospective study)
Scientific Title:Acronym
A multicenter prospective study of the impact of single antithrombotic drug continuation on postoperative bleeding after PTGBD
Region
| Japan |
Condition
Condition
Patients with indication of PTGBD for acute cholecystitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospective assessment of bleeding rates after PTGBD in patients with acute cholecystitis receiving continuous single antithrombotic drug
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency and severity of bleeding after PTGBD in patients with acute cholecystitis according to the use of the antithrombotic drug
Key secondary outcomes
1. The factors associated with whole bleeding and severe bleeding after PTGBD
2. The frequency of postoperative bleeding for each antithrombotic drug and comparison of bleeding rates for antiplatelets and anticoagulants
3. Relationship between frequency of patients receiving appropriate dosage of DOACs according to renal function and bleeding rates after PTGBD in patients receiving DOACs
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 18 years-old at the time of entry
Patients with indication of PTGBD for acute cholecystitis
Patients with no antithrombotic drug use or receiving a single antithrombotic drug before PTGBD
Patients who have provided written consent for participation
Key exclusion criteria
Patients receiving multiple antithrombotic drugs
Patients who cannot consent to participate
Patients judged by study investigator/sub-investigators as inappropriate ones
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Hikita |
Organization
Osaka University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
5650871
Address
Yamada-oka 2-2, Suita, Osaka, Japan
TEL
0668793621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Yoshioka |
Organization
Osaka University Graduate School of medicine
Division name
Gastroenterology and Hepatology
Zip code
5650871
Address
Yamada-oka 2-2, Suita, Osaka, Japan
TEL
0668793621
Homepage URL
teyoshioka@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Hikita Hayato
Funding Source
Organization
Osaka University Graduate School of Medicine, department of Gastroenterology
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
Osaka University Hospital Institutional Review Board
Address
Yamadaoka 2-2, Suita, Osaka, Japan
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.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
| 2024 | Year | 07 | 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
| 2024 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2024 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062370
