UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A new endoscopic transpapillary gallbladder drainage technique combined with intraductal ultrasonography for patients with acute cholecystitis.
Title of the study (Brief title)	transpapillary gallbladder drainage technique combined with intraductal ultrasonography
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of endoscopic transpapillary gallbladder drainage with intraductal ultrasound.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Success of endoscopic transpapillary gallbladder drainage.
Key secondary outcomes

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	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Perform endoscopic transpapillary gallbladder drainage combined with intraductal ultrasound.
Interventions/Control_2	Perform endoscopic transpapillary gallbladder drainage combined without intraductal ultrasound.
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 that must be perforemed drainage.
Key exclusion criteria	patients with common bile duct stone before gallbladder drainage
Target sample size	100

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

Public contact
Name of contact person	Ryota Sagami
Organization	New Tokyo Hospital
Division name	Department of Gastroenterology
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)

Secondary IDs
Secondary IDs	YES
Study ID_1	99
Org. issuing International ID_1	New Tokyo Hospital Institutional Review Board number 99
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	新東京病院

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 01 Month 23 Day
Last modified on	2019 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040606