UMIN-CTR Clinical Trial

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