UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic indwelling gallbladder drainage (EIGBD) with a trimmed nasobiliary tube for acute cholecystitis: a prospective pilot study
Title of the study (Brief title)	BLADE Study
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 stenting using trimmed nasobiliary drainage tube for acute cholecystitis scheduled to elective cholecystectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Technical success rate Clinical success rate
Key secondary outcomes	Length of procedure Incidence of complication Duration of hospital stay

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	Therapeutic ERCP
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Moderate acute cholecystitis, diagnosed according to the Tokyo guidelines 2007 criteria. 2.Patients with tolerable for elective surgery. 3.Performance status 0-3.
Key exclusion criteria	1.age <20 years. 2.PS 4 3.Patients with surgical altered anatomy such as Billroth II or Roux-en-Y anastomosis. 4.Possible or current pregnancy.
Target sample size	40

Research contact person
Name of lead principal investigator	Ichiro Yasuda
Organization	Teikyo University MIzonokuchi Hospital
Division name	Dept. of Gastroenterology
Address	3-8-3, Mizokuchi, Takatsu-ku, Kawasaki city, Kanagawa pref., Japan
TEL	044-844-3333
Email	sinpesan@gmail.com

Public contact
Name of contact person	Shinpei Doi
Organization	Teikyo University MIzonokuchi Hospital
Division name	Dept. of Gastroenterology
Address	3-8-3, Mizokuchi, Takatsu-ku, Kawasaki city, Kanagawa pref., Japan
TEL	044-844-3333
Homepage URL
Email	sinpesan@gmail.com

Sponsor
Institute	Teikyo University MIzonokuchi Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	1) Gifu Municipal Hospital 2) Gifu Prefectural Medical Center 3) Gifu University Hospital
Name of secondary funｄer(s)

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 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 05 Day
Anticipated trial start date	2013 Year 01 Month 13 Day
Last follow-up date	2015 Year 12 Month 31 Day
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	2013 Year 01 Month 02 Day
Last modified on	2017 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011352