UMIN-CTR Clinical Trial

Basic information
Public title	Comparative study on the usefulness of endoscopic retrograde gallbladder drainage and endoscopic ultrasound-guided gallbladder drainage for inoperative cases with acute cholecystitis: Randomized controlled trial.
Acronym	Comparative study of endoscopic therapy for acute cholecystitis
Scientific Title	Comparative study on the usefulness of endoscopic retrograde gallbladder drainage and endoscopic ultrasound-guided gallbladder drainage for inoperative cases with acute cholecystitis: Randomized controlled trial.
Scientific Title:Acronym	Comparative study of endoscopic therapy for acute cholecystitis
Region	Japan

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

Objectives
Narrative objectives1	To determine the appropriate treatment for patients with acute cholecystitis who have no indication for emergency surgery via comparison of the efficacy and safety of ERGBD VS EUS-GBD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Efficiency of each treatment Disappearance of abdominal pain Normalization of white blood cell count Half of C-reactive protein value
Key secondary outcomes	Procedure success rate Treatment time Complication rate Recurrence rate of cholecystitis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Patients with acute cholecystitis treated by ERGBD.
Interventions/Control_2	Patients with acute cholecystitis treated by EUS-GBD.
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	Patients with acute cholecystitis determined emergency drainage is necessary Patients who are not indicated for surgery or PTGBD due to poor general condition, oral antithrombotic drugs, elderly, etc. Those who are able to follow the passage of 60 days after treatment.
Key exclusion criteria	Patients with multiple organ dysfunction Patients with common bile duct stones Pregnant, Female patient with potential for pregnancy or lactating Patients who are complicated with psychosis or psychiatric symptoms and seem to be difficult to participate in the study Patients who are allergic to antibiotics
Target sample size	120

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Ryota Sagami
Organization	New Tokyo Hospital
Division name	Department of Gastroenterology
Zip code
Address	1271 Wanagaya, Matsudo Chiba, Japan
TEL	0477118700
Email	sagami1985@yahoo.co.jp

Public contact
1st name of contact person	1st name Middle name Last name Ryota Sagami
Organization	New Tokyo Hospital
Division name	Department of Gastroenterology
Zip code
Address	1271 Wanagaya, Matsudo Chiba, Japan
TEL	0477118700
Homepage URL
Email	sagami1985@yahoo.co.jp

Sponsor
Institute	New Tokyo Hospital
Institute
Department

Funding Source
Organization	New Tokyo Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Oita San-ai Medical Center
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	2018 Year 03 Month 20 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	2018 Year 03 Month 10 Day
Date of IRB	2018 Year 03 Month 10 Day
Anticipated trial start date	2018 Year 03 Month 10 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 14 Day
Last modified on	2019 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036218