UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of endoscopic ultrasound-guided hepaticogastrostomy in patients with a surgically altered upper gastrointestinal tract
Title of the study (Brief title)	EUS-HGS for patients with a surgically altered GI tract
Region	Japan

Condition
Condition	Unresectable malignant biliary obstruction with a surgically altered uuper gastrointestinal tract
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility and safety of EUS-HGS
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A technical and clinical success rate
Key secondary outcomes	Complications, Time to dysfunction

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Unresectable malignant biliary obsturction 2)T-Bil > 3.0mg/dl 3)Performance status(PS) Grade 0-3 4)Age >20years 5)Written informed consent was obrained
Key exclusion criteria	1)Billroth I or II reconstruction 2)Severe cholangitis 3)Ileus 4)Severe cardio-respiratory failure 5)Severe renal failure 6)Steroid therapy(PSL5mg/dl more than 1 month) 7)Severe ascites 8)Severe bleeding diathesis 9)Imparied conciousness (>JCS I-1) 10)Severe cardiac diseases 11)Severe respiratory disease 12)Pregnant women
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroyuki Isayama
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Gastroenterology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Gastroenterology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2011 Year 12 Month 08 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 11 Month 04 Day
Anticipated trial start date	2011 Year 12 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	None

Management information
Registered date	2011 Year 12 Month 07 Day
Last modified on	2017 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008109