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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042402
Receipt No. R000048402
Scientific Title Long-term outcome of Endoscopic gallbladder stenting
Date of disclosure of the study information 2020/11/16
Last modified on 2020/11/09

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Basic information
Public title Endoscopic gallbladder stenting versus removal of gallbladder drainage, long-term outcome in management of acute cholecystitis in surgical high-risk patients for cholecystectomy
Acronym Long-term outcome of Endoscopic gallbladder stenting
Scientific Title Long-term outcome of Endoscopic gallbladder stenting
Scientific Title:Acronym Long-term outcome of Endoscopic gallbladder stenting
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 long-term outcome of long-term EGBS and removal of gallbladder drainage after PTGBD or ETGBD for acute cholecystitis in surgical high-risk patients and to clarify the usefulness of long-term EGBS.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes To compare the long-term outcome between the EGBS and PT/ENGBD group.
Key secondary outcomes Comparison of the technical success rate, clinical success rate, and early AE rate between the ETGBD and PTGBD.

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
36 years-old <=
Age-upper limit
97 years-old >=
Gender Male and Female
Key inclusion criteria Patients who were considered as surgical high-risk patients and underwent either ETGBD or PTGBD for acute cholecystitis.
Key exclusion criteria Prior history of upper gastrointestinal or biliary tract surgery, except for gastrectomy with Billroth I reconstruction; presence of pancreatobiliary malignancies; presence of bile duct stricture, including primary sclerosing cholangitis.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Akinori
Middle name
Last name Maruta
Organization Gifu prefectural general medical center
Division name Department of Gastroenterology
Zip code 500-8717
Address 4-6-1 Noisshiki, Gifu City
TEL 058-246-1111
Email mrak5844@yahoo.co.jp

Public contact
Name of contact person
1st name Akinori
Middle name
Last name Maruta
Organization Gifu prefectural general medical center
Division name Department of Gastroenterology
Zip code 500-8717
Address 4-6-1 Noisshiki, Gifu City
TEL 058-246-1111
Homepage URL
Email mrak5844@yahoo.co.jp

Sponsor
Institute Gifu prefectural general medical center
Institute
Department

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 Gifu prefectural general medical center
Address 4-6-1 Noisshiki, Gifu City
Tel 058-246-1111
Email chiken-center.4289@gifu-hp.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
2020 Year 11 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 180
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
2020 Year 11 Month 01 Day
Date of IRB
2020 Year 12 Month 01 Day
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This was a retrospective cohort study conducted at three tertiary care centers: Gifu Prefectural General Medical Center, Gifu University Hospital, and Gifu Municipal Hospital. The database used for this study included clinical data of all ERCP and PTGBD procedures performed at these three institutions between January 2010 and December 2018.Inclusion criteria were patients who were considered as surgical high-risk patients and underwent either ETGBD or PTGBD for acute cholecystitis.

Management information
Registered date
2020 Year 11 Month 09 Day
Last modified on
2020 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048402

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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