UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032076 |
|---|---|
| Receipt number | R000036141 |
| Scientific Title | A multi-center, randomized, controlled trial on the efficacy and safety of metal stents for biliary drainage prior to pancreatic cancer surgery |
| Date of disclosure of the study information | 2018/04/04 |
| Last modified on | 2019/06/08 16:06:41 |
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Basic information
Public title
A multi-center, randomized, controlled trial on the efficacy and safety of metal stents for biliary drainage prior to pancreatic cancer surgery
Acronym
A multi-center, randomized, controlled trial on the efficacy and safety of metal stents for biliary drainage prior to pancreatic cancer surgery
Scientific Title
A multi-center, randomized, controlled trial on the efficacy and safety of metal stents for biliary drainage prior to pancreatic cancer surgery
Scientific Title:Acronym
A multi-center, randomized, controlled trial on the efficacy and safety of metal stents for biliary drainage prior to pancreatic cancer surgery
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to examine the efficacy and safety of metal stents compared with those of plastic stents for preoperative biliary drainage in pancreatic cancer patients with obstructive jaundice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Any symptoms from the time of biliary stent placement to the surgery. In other patients, the outcome will be the time to the decision not to undergo surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
conventional therapy:Endoscopic Biliary Drainage by 10 Fr plastic stent.
Observation period: postoperative day 120 or death.
Interventions/Control_2
new therapy:Endoscopic Biliary Drainage by Fully covered self-expandable metallic stent.
Observation period: postoperative day 120 or death.
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) 20 years old. regardless of sex.
2) Written informed consent
3) resectable or borderline resectable pancreatic cancer
4) adenocarcinoma or adenosquamous carcinoma or obvious pancreatic cancer
5) with distal biliary obstruction
6) need for Biliary Drainage
7) less than 2 weeks from Biliary Drainage
Key exclusion criteria
1) under 2cm from hilar bile duct to stenosis
2) with Gastric outlet obstruction
3) with Serious complications
4) endoscopic approach is difficult
5) except Billroth I reconstruction
6) Benign stenosis
7) Hilar bile duct stenosis
8) more than 2 weeks from Biliary Drainage
9) less than 2 weeks until operation
10) with metastasis
11) Pregnant women
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
Address
3-1-3 Hongo Bunkyo-ku Tokyo
TEL
03-3813-3111
h-isayama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinori Suzuki |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
Address
3-1-3 Hongo Bunkyo-ku Tokyo
TEL
03-3813-3111
Homepage URL
suzukia@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific Corporation
Organization
Division
Category of Funding Organization
Outside Japan
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
| 2018 | Year | 04 | Month | 04 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036141
