UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study to assess the efficacy and safety of endoscopic ultrasound-guided gallbladder drainage using a metal stent with larger diameter head
Acronym	A prospective study to assess the efficacy and safety of EUS-GBD using a metal stent with larger diameter head
Scientific Title	Safety and effectiveness of EUS-GBD using a metal stent with a metal stent with larger diameter head: a prospective study
Scientific Title:Acronym	Safety and effectiveness of EUS-GBD using a metal stent with a metal stent with larger diameter head: a prospective study
Region	Japan

Condition
Condition	Acute cholecystitis
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to evaluate the efficacy and safety of EUS-GBD using a metal stent with larger diameter head
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy (Technical success rate, Functional success rate, migration rate)
Key secondary outcomes	Safety (Adverse events rate)

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patient with acute cholecystitis who is planned for EUS-GBD 2) Age >20 3) Written informed consent
Key exclusion criteria	1) PS 4 2) Patients who cannot stop antithrombotic drugs 3) Pregnant woman 4) Platelet < 50000/uL 5) PT-INR > 1.5 6) Inappropriate patient
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hirotoshi Middle name Last name Ishiwatari
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
Zip code	411-8777
Address	1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
TEL	055-989-5222
Email	ishihiro481019@gmail.com

Public contact
Name of contact person	1st name Hirotoshi Middle name Last name Ishiwatari
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
Zip code	411-8777
Address	1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
TEL	055-989-5222
Homepage URL
Email	ishihiro481019@gmail.com

Sponsor
Institute	Division of Endoscopy, Shizuoka Cancer Center
Institute
Department

Funding Source
Organization	No 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	Shizuoka Cancer Center
Address	1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
Tel	055-989-5222
Email	ishihiro481019@gmail.com

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	静岡がんセンター

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 25 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	5
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	Terminated
Date of protocol fixation	2020 Year 04 Month 20 Day
Date of IRB	2020 Year 05 Month 15 Day
Anticipated trial start date	2020 Year 05 Month 25 Day
Last follow-up date	2023 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In the prospective study, we will evaluate the technical/ functional success rate and stent migration rate. Stent migration is defined as completely or partially migrated stent into the gall bladder or the gastrointestinal tract. We will evaluate adverse events including stent migration through scheduled follow-up until patient death or 1 year after stent placement.

Management information
Registered date	2020 Year 05 Month 25 Day
Last modified on	2021 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046124