UMIN-CTR Clinical Trial

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