UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056960 |
|---|---|
| Receipt number | R000065014 |
| Scientific Title | Prospective Observational Study on the Utility of Endoscopic Ultrasound-Guided Gallbladder Drainage (EUS-GBD) Using a 0.81-mm Guidewire |
| Date of disclosure of the study information | 2025/02/06 |
| Last modified on | 2025/02/06 23:27:40 |
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Basic information
Public title
Effectiveness of Gallbladder Drainage with a 0.81-mm Guidewire
Acronym
EUS-GBD with 0.81-mm GW
Scientific Title
Prospective Observational Study on the Utility of Endoscopic Ultrasound-Guided Gallbladder Drainage (EUS-GBD) Using a 0.81-mm Guidewire
Scientific Title:Acronym
Prospective Observational EUS-GBD with 0.81-mm GW Study
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 effectiveness and safety of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a 0.81-mm guidewire for acute cholecystitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the effectiveness and safety of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a 0.81-mm guidewire for acute cholecystitis and to assess the insertion rate of a 7Fr plastic stent among all cases.
Key secondary outcomes
Technical success rate of EUS-GBD without fistula dilation
Clinical success rate
Adverse event rate
Length of hospital stay
Stent patency duration during the observation period
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 diagnosed with acute cholecystitis who require gallbladder drainage.
Patients with moderate acute cholecystitis or mild cases that do not respond to initial treatment.
Patients with a Performance Status (PS) Grade of 0-4.
Patients aged 18 years or older at the time of consent.
Patients who have received a thorough explanation of the study, fully understood its details, and provided written informed consent voluntarily.
Key exclusion criteria
Patients with severe cholecystitis, as defined by the Tokyo Guidelines 2018.
Patients with concomitant cholangitis due to bile duct stones.
Patients with a history of gastrectomy (Billroth I reconstruction, Billroth II reconstruction, or Roux-en-Y reconstruction).
Patients with unstable respiratory or circulatory status.
Patients receiving long-term steroid therapy.
Patients with severe ascites.
Patients with a severe bleeding tendency.
Patients with severe cardiac disease.
Pregnant or lactating women, or those who may be pregnant.
Patients deemed inappropriate for the study by the principal investigator or sub-investigators.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Hidenobu |
| Middle name | |
| Last name | Hara |
Organization
Yokohama City Minato Red Cross Hospital
Division name
Gastroenterology
Zip code
2318682
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa, Japan
TEL
0456286100
hidenobu1005_0406@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hidenobu |
| Middle name | |
| Last name | Hara |
Organization
Yokohama City Minato Red Cross Hospital
Division name
Gastroenterology
Zip code
2318682
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa, Japan
TEL
0456286100
Homepage URL
hidenobu1005_0406@yahoo.co.jp
Sponsor or person
Institute
Yokohama City Minato Red Cross Hospital
Institute
Department
Personal name
Hidenobu Hara
Funding Source
Organization
Self funding
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
Yokohama City Minato Red Cross Hospital
Address
3-12-1 Shinyamashita, Naka-ku, Yokohama, Kanagawa, Japan
Tel
0456286100
hidenobu1005_0406@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
横浜市立みなと赤十字病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 06 | 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 | 12 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 06 | Day |
Date of closure to data entry
| 2028 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2028 | Year | 02 | Month | 10 | Day |
Date analysis concluded
| 2028 | Year | 05 | Month | 10 | Day |
Other
Other related information
prospective observational study
Management information
Registered date
| 2025 | Year | 02 | Month | 06 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065014
