UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006857 |
|---|---|
| Receipt number | R000008109 |
| Scientific Title | A prospective study of endoscopic ultrasound-guided hepaticogastrostomy in patients with a surgically altered upper gastrointestinal tract |
| Date of disclosure of the study information | 2011/12/08 |
| Last modified on | 2017/06/10 10:20:55 |
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Basic information
Public title
A prospective study of endoscopic ultrasound-guided hepaticogastrostomy in patients with a surgically altered upper gastrointestinal tract
Acronym
EUS-HGS for patients with a surgically altered GI tract
Scientific Title
A prospective study of endoscopic ultrasound-guided hepaticogastrostomy in patients with a surgically altered upper gastrointestinal tract
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2011 | Year | 11 | Month | 04 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008109
