UMIN-CTR Clinical Trial

Basic information
Public title	Prospective comparative study of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder aspiration and percutaneous transhepatic gallbladder drainage for acute cholecystitis
Acronym	Prospective comparative study of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder aspiration and percutaneous transhepatic gallbladder drainage for acute cholecystitis
Scientific Title	Prospective comparative study of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder aspiration and percutaneous transhepatic gallbladder drainage for acute cholecystitis
Scientific Title:Acronym	Prospective comparative study of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder aspiration and percutaneous transhepatic gallbladder drainage for acute cholecystitis
Region	Japan

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

Objectives
Narrative objectives1	The aim of this clinical trial is to evaluate effectiveness and safety of endoscopic naso-gallbladder drainage and percutaneous transhepatic gallbladder aspiration for acute cholecystitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	treatment period
Key secondary outcomes	safety efficiency success rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	endoscopic naso-gallbladder drainage
Interventions/Control_2	percutaneous transhepatic gallbladder aspiration
Interventions/Control_3	percutaneous transhepatic gallbladder drainage
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	Patients with necessary of teatment with drainage for acute cholecystitis ,which is defined by "Tokyo Guidelines for the management of acute cholangitis and cholecystitis"
Key exclusion criteria	1) Patients with choledocholithiasis 2) Patients with mild acute cholecystitis who improved conservative therapy 3) Patients with emphysematous cholecystitis or gallbladder perforation or complicated with biliary peritonitis 4) Inappropriate patients for entry on this study by the judgement of the investigators
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Motoyoshi IZUMI
Organization	Machida Municipal Hospital
Division name	Department of Gastroenterology
Zip code
Address	2-15-41 Asahimachi, Machida-shi, Tokyo, Japan
TEL	042-722-2230
Email	y.masui@machida-city-hp.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshifumi Masui
Organization	Machida Municipal Hospital
Division name	Department of Gastroenterology
Zip code
Address	2-15-41 Asahimachi, Machida-shi, Tokyo, Japan
TEL	042-722-2230
Homepage URL
Email	y.masui@machida-city-hp.jp

Sponsor
Institute	Machida Municipal Hospital
Institute
Department

Funding Source
Organization	Machida Municipal Hospital
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
Address
Tel
Email

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	2013 Year 11 Month 15 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	Terminated
Date of protocol fixation	2013 Year 11 Month 15 Day
Date of IRB	2013 Year 11 Month 13 Day
Anticipated trial start date	2013 Year 11 Month 15 Day
Last follow-up date	2016 Year 09 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 11 Month 15 Day
Last modified on	2022 Year 05 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014388