UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035387 |
|---|---|
| Receipt number | R000040246 |
| Scientific Title | A randomized controlled trial comparing 10mm metallic stent versus 14mm metallic stent for distal biliary obstruction caused by pancreatic carcinoma |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2023/05/21 17:24:06 |
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Basic information
Public title
A randomized controlled trial comparing 10mm metallic stent versus 14mm metallic stent for distal biliary obstruction caused by pancreatic carcinoma
Acronym
A randomized controlled trial comparing 10mm metallic stent versus 14mm metallic stent for distal biliary obstruction caused by pancreatic carcinoma
Scientific Title
A randomized controlled trial comparing 10mm metallic stent versus 14mm metallic stent for distal biliary obstruction caused by pancreatic carcinoma
Scientific Title:Acronym
A randomized controlled trial comparing 10mm metallic stent versus 14mm metallic stent for distal biliary obstruction caused by pancreatic carcinoma
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to compare the time to recurrent biliary obstruction of metallic stent between 10mm and 14mm in diameter in patients with pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to recurrent biliary obstruction (TRBO)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Biliary metallic stent with 10mm in size
Interventions/Control_2
Biliary metallic stent with 14mm in size
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) Patients with jaundice or liver dysfunction
(2) Pathologically confirmed as cancer
(3) No indication for surgical resection
(4) The diameter of dilated bile duct >= 14mm
(5) Distal bile duct obstruction which is not reached in the hilar region
(6) Performance status(ECOG) is 0~1.
(7) Prognosis will be >= 4 months.
Key exclusion criteria
(1) Patients with history of gastrectomy and reconstruction other than Billroth I anastomosis
(2) Duodenal obstruction in anal side of major papilla
(3) Patients with history of insertion of biliary metallic stent
(4) ASA >= 3
(5) Patients with acute pancreatitis or exacerbation of chronic pancreatitis
(6) Patients with liver cirrhosis
(7) Patients with Platelet count=< 50,000 mm3
(8) A participating doctor thinks the patient is inappropriate for this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Ishiwatari |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
411-8777
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
TEL
055-989-5222
ishihiro481019@gmail.com
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Honda |
Organization
Shizuoka Cancer Center
Division name
Clinical Research Center
Zip code
411-8777
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
TEL
055-989-5222
Homepage URL
yu.honda@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
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
The committee of IRB, Shizuoka Cancer Center
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka
Tel
055-989-5222
rinsho_office@scchr.jp
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
| 2019 | Year | 02 | Month | 01 | 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
| 2018 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2018 | Year | 12 | Month | 28 | Day |
Last modified on
| 2023 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040246
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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