UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004044 |
|---|---|
| Receipt number | R000003564 |
| Scientific Title | A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of covered self-expandable metallic stent for biliary obstruction from unresectable pancreatic cancer. |
| Date of disclosure of the study information | 2010/08/16 |
| Last modified on | 2014/07/18 12:33:51 |
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Basic information
Public title
A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of covered self-expandable metallic stent for biliary obstruction from unresectable pancreatic cancer.
Acronym
A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of stent.
Scientific Title
A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of covered self-expandable metallic stent for biliary obstruction from unresectable pancreatic cancer.
Scientific Title:Acronym
A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of stent.
Region
| Japan |
Condition
Condition
biliary obstruction from unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical safety and efficacy of endoscopic sphincterotomy (EST) in placement of covered self-expandable metallic stent (c-SEMS) for biliary obstruction from unresectable pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
early complications rate (within 30 days following c-SEMS placement)
Key secondary outcomes
1. dulation of endoscopy
2. success rate of c-SEMS placement and and drainage
3. late complicaions rate (from 30 days to stent replacement or detah)
4. patency dulation of c-SEMS
5. cause of c-SEMS obstruction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
EST
Interventions/Control_2
non EST
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. The biliary tract obstruction from pancreatic cancer is diagnosed based on the imaging findings and biliary drainage is necessary for the obstruction.
2. Acute cholangitis is treated successfully by systemic antibiotics with or without percutaneous or transpapillary drainage of biliary truct.
3. The involvement of pancreatic cancer to the region of papilla of Vater is not detected by the endoscopic procedure.
4. Pancreatic cancer which is histologically or cytologically proven malignancy.
5. Pancreatic cancer is considered unresectable owing to advanced stage, cormobidity and/or age.
6. The bile duct obstruction is not found in the hilar region.
7. Patients fully understand and are willing to give a written informed consent about participation.
Key exclusion criteria
1. Performance status is 4.
2. Japan Coma Scale (JCS) >=I-1.
3. Severe heart disease.
4. Severe lung disease.
5. PT INR >= 1.5.
6. Plt =< 50,000 mm3.
7. Patients who can not discontinue anticoagulant or antiplatelet drugs.
8. Age is lower than 20 years.
9. Patients with history of insertion of biliay stent which is larger bore than 8 Fr.
10. Patients with history of previous endoscopic sphincterotomy.
11. Patients with Billroth II or Roux-en-Y reconstruction after gastrectomy.
12. Patients with pancreaticobiliary maljunction.
13. Patients with distal intestinal obstruction from ampulla of Vater.
14. Patients considered ineligible for this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Hayashi |
Organization
Sapporo medical university
Division name
Fourth Department of Internal Medicine
Zip code
Address
South-1, West-16, Chuo-ku Sapporo, Hokkaido, 060-8556, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Sapporo Medical University
Division name
Fourth Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
thayashi69@sapmed.ac.jp
Sponsor or person
Institute
Fourth Department of Internal Medicine, Sapporo medical university
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
| 2010 | Year | 08 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 16 | Day |
Last modified on
| 2014 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003564
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