UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of endoscopic transpapillary gallbladder drainage for patients with acute cholecystitis under single and multi antithrombotic therapy.
Acronym	The efficacy of endoscopic transpapillary gallbladder drainage for patients under antithrombotic therapy.
Scientific Title	The efficacy of endoscopic transpapillary gallbladder drainage for patients with acute cholecystitis under single and multi antithrombotic therapy.
Scientific Title:Acronym	The efficacy of endoscopic transpapillary gallbladder drainage for patients under antithrombotic therapy.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of ETGBD for patients with antithrombotic therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The severe bleeding complications that requires transfusion after the procedure.
Key secondary outcomes

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	20 years-old <=
Age-upper limit	98 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients with grade2,3 acute cholecystitis, or grade1 acute cholecystitis with severe inflammatory findings in blood test. 2. Patients who could not be treated by surgery or percutaneous transhepatic gallbladder drainage due to antithrombotic therapy. 3. Patients who agreed the treatment with informed consent before the procedure.
Key exclusion criteria	1. Patients with cholecystitis due to common bile duct stone. 2. The female patient during pregnancy.
Target sample size	80

Research contact person
Last name of lead principal investigator	1st name Ryota Middle name Last name Ryota Sagami
Organization	New Tokyo Hospital
Division name	Department of Gastroenterology
Zip code	270-2232
Address	1271 Wanagaya, Matsudo, Chiba, Japan
TEL	0477118700
Email	sagami1985@yahoo.co.jp

Public contact
1st name of contact person	1st name Ryota Middle name Last name Sagami
Organization	New Tokyo Hospital
Division name	Department of Gastroenterology
Zip code	270-2232
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	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	New Tokyo Hospital
Address	1271 Wanagaya, Matsudo, Chiba, Japan
Tel	0477118700
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	2019 Year 03 Month 01 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	2015 Year 01 Month 01 Day
Date of IRB	2019 Year 01 Month 25 Day
Anticipated trial start date	2019 Year 01 Month 25 Day
Last follow-up date	2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The procedures that were already performed are analized retrospectively.

Management information
Registered date	2019 Year 03 Month 01 Day
Last modified on	2019 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041071