UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007183 |
|---|---|
| Receipt number | R000008462 |
| Scientific Title | Preoperative Biliary Drainage with Fully-Covered Self-Expandable Metallic Stents for Pancreas Head Cancer |
| Date of disclosure of the study information | 2012/01/31 |
| Last modified on | 2013/08/06 09:37:15 |
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Basic information
Public title
Preoperative Biliary Drainage with Fully-Covered Self-Expandable Metallic Stents for Pancreas Head Cancer
Acronym
Preoperative Biliary Drainage with Fully-Covered Self-Expandable Metallic Stents for Pancreas Head Cancer
Scientific Title
Preoperative Biliary Drainage with Fully-Covered Self-Expandable Metallic Stents for Pancreas Head Cancer
Scientific Title:Acronym
Preoperative Biliary Drainage with Fully-Covered Self-Expandable Metallic Stents for Pancreas Head Cancer
Region
| Japan |
Condition
Condition
Pancreas Head Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety and efficacy of preoperative biliary drainage using a covered self-expandable metallic stent for pancreatic head cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
complication rate
Key secondary outcomes
survival at the 90 days after the operation
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
| Device,equipment | Maneuver |
Interventions/Control_1
placement of a covered self-expandable metallic stent
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
Patients who are strongly suspected of pancreatic head cancer based on the imaging examinations.
Patients who plesented obstructive jaundice(T-Bil is over 5.0mg/dL) or liver dysfunction(AST is more than 3 times the upper limit of normal).
Patients who are a candidate for surgery.
Written informed consent is obtained from patient before the study.
Key exclusion criteria
Patients who are not able to stop the anti-coagulant therapy.
Patients who have severe heart disease, hepatic insufficiency, renal dysfunction, endocrine disease, or gastrointestinal tract disturbance.
Pregnant women. Women who have possibility of pregnancy.
Patients who are suspected of tumor involvement to the orifice of cystic duct.
Patients who are not suitable for endoscopic procedures.
Patients who already have received the endoscopic or percutaneously or surgically biliary drainage.
Patients who have symptoms of gastric outlet obstruction.
Patients who are judged inappropriate by chief (responsive) medical examiner
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Togawa |
Organization
Saitama International Medical Center
Division name
Depertment of Gastroenterology
Zip code
Address
1397-1 Yamane, Hidaka, Saitama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Togawa |
Organization
Saitama International Medical Center
Division name
Depertment of Gastroenterology
Zip code
Address
1397-1 Yamane, Hidaka, Saitama
TEL
Homepage URL
Sponsor or person
Institute
Saitama International Medical Center
Institute
Department
Personal name
Funding Source
Organization
nothing
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
| 2012 | Year | 01 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 31 | Day |
Last modified on
| 2013 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008462
