UMIN-CTR Clinical Trial

Basic information
Public title	A Multicenter, Prospective Randomized Study comparing Fully Covered Metal Stent and Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer
Acronym	Comparison of Metal Stent with Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer
Scientific Title	A Multicenter, Prospective Randomized Study comparing Fully Covered Metal Stent and Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer
Scientific Title:Acronym	Comparison of Metal Stent with Plastic Stent for Preoperative Biliary Drainage in Resectable Pancreatic Cancer
Region	Japan Asia(except Japan)

Condition
Condition	Obstructive jaundice caused by resectable pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare preliminary placement of FCMS and PS for obstructive jaundice caused by resectable pancreatic cancer with preoperative endoscopic drainage through a randomized musticenter controlled study and to evaluate the rate of re-intervention as well as post operative complication.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of re-intervention related to stent during the time from drainage to surgical operation
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	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Fully covered metal stent cohort
Interventions/Control_2	Plastic stent cohort
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	Patients are eligible for this Study if they meet all the criteria shown below. Patients who are over 20 years old Patients who are suspected to have a carcinoma of the head of the pancreas which is determined to be resectable from the image, and a resection is scheduled as of ERCP conduction timing. Patients who show obstructive jaundice caused by biliary stricture Patients with stricture occurring at middle or lower part of the biliary Patients for whom NO preoperative chemical radiation therapy is planned
Key exclusion criteria	Patients are to be excluded from this Study if they conflict with any of the criteria shown below Patients who have previously received the procedure of cholecystectomy or endoscopic sphincterotomy Patients who score 4 in Performance Status Patients with serious complication on other organ(s): Higher than 3 with ASA category (dialyzed patients are also excluded) Patients judged to have less than 3 months of life expectancy
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takao Itoi
Organization	Tokyo Medical University Hospital
Division name	Department of Gastroenterology
Zip code
Address	6-7-1 Nishi-Sinjyuku-ku, Tokyo
TEL	03-3342-6111
Email	itoi@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takayoshi Tsuchiya
Organization	Tokyo Medical University Hospital
Division name	Department of Gastroenterology
Zip code
Address	6-7-1 Nishi-Sinjyuku-ku, Tokyo
TEL	03-3342-6111
Homepage URL
Email	tsuchiya@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Medical University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	2016 Year 07 Month 23 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	2016 Year 02 Month 26 Day
Date of IRB	2016 Year 02 Month 26 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2020 Year 08 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	2016 Year 07 Month 22 Day
Last modified on	2021 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026853