UMIN-CTR Clinical Trial

Basic information
Public title	Utility of emergency endoscopic drainage for patient with antithrombotic therapy.
Acronym	Endoscopic drainage for patient with antithrombotic therapy.
Scientific Title	Utility of emergency endoscopic drainage for patient with antithrombotic therapy.
Scientific Title:Acronym	Endoscopic drainage for patient with antithrombotic therapy.
Region	Japan

Condition
Condition	Patients with operable acute cholecystitis during antithrombotic therapy. Patients with inoperable acute cholecystitis accompany with common bile duct stone.
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the appropriate endoscopic treatment: ETGBD and EUS-GBD for patients with acute cholecystitis who have no indication for emergency surgery because of antithrombotic therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficiency of ETGBD Efficiency of EUS-GBD for patients who ETGBD was unsuccessful. Disappearance of abdominal pain Normalization of white blood cell count Improvement 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	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Treatment of ETGBD for patients with acute cholecystitis. In case of failure, PTGBD or EUS-GBD is alternatively performed.
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	98 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with acute cholecystitis requiring elective emergency drainage is necessary. Patients who are not indicated for surgery or PTGBD due to poor general condition, oral antithrombotic drugs, elderly, etc. Those are able to follow until cholecystectomy or inoperable.
Key exclusion criteria	Patients with multiple organ dysfunction Patients with common bile duct stones Pregnant, Female patient with potential for pregnancy or lactating
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Sagami
Organization	Oita San-ai Medical Center
Division name	Department of Gastroenterology
Zip code	870-1151
Address	1213, Oaza Ichi, Oita, Oita 870-1151, Japan.
TEL	+81-97-541-1311
Email	sagami1985@yahoo.co.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Sagami
Organization	Oita San-ai Medical Center
Division name	Department of Gastroenterology
Zip code	870-1151
Address	1213, Oaza Ichi, Oita, Oita 870-1151, Japan.
TEL	+81-97-541-1311
Homepage URL
Email	sagami1985@yahoo.co.jp

Sponsor
Institute	Oita San-ai 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	Oita San-ai Medical Center
Address	1213, Oaza Ichi, Oita, Oita 870-1151, Japan.
Tel	+81-97-541-1311
Email	sagami1985@yahoo.co.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	2018 Year 05 Month 21 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	Open public recruiting
Date of protocol fixation	2018 Year 04 Month 30 Day
Date of IRB	2018 Year 04 Month 30 Day
Anticipated trial start date	2018 Year 04 Month 30 Day
Last follow-up date	2022 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 05 Month 21 Day
Last modified on	2020 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036998