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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032076
Receipt No. 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

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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
Email 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
Email suzukia@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036141

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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