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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030200
Receipt No. R000034497
Scientific Title Modified Fully Covered Self-expandable Metal Stent vs. Plastic Stent for Preoperative Biliary Drainage in Patients with Resectable Malignant Biliary Obstruction
Date of disclosure of the study information 2018/12/31
Last modified on 2017/11/30

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Basic information
Public title Modified Fully Covered Self-expandable Metal Stent vs. Plastic Stent for Preoperative Biliary Drainage in Patients with Resectable Malignant Biliary Obstruction
Acronym M-FCSEMS for preoperative biliary drainage
Scientific Title Modified Fully Covered Self-expandable Metal Stent vs. Plastic Stent for Preoperative Biliary Drainage in Patients with Resectable Malignant Biliary Obstruction
Scientific Title:Acronym M-FCSEMS for preoperative biliary drainage
Region
Asia(except Japan)

Condition
Condition Under IRB
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the superiority of modified FCSEMS (M-FCSEMS) over PS, by comparing the PBD-related adverse events, re-intervention rate, and perioperative adverse events in patients with resectable MBO
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PBD-related adverse events during the interval
period up to surgery
Key secondary outcomes Re-intervention rate requiring additional procedure before surgery and Perioperative adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 During August 2015 - August 2017
ERCP and biliary drainage with BONASTENT M-intraductal 12 or plastic stent performed.
Re-intervention was performed for stent exchange or additional procedure when patients developed cholangitis, stent migration, and other adverse events before surgery.
Interventions/Control_2
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria -Age between 18 and 80 years
-MBO at least 10 mm below the hilar bifurcation
-Obstructive jaundice and/or cholangitis
-No evidence of distant metastasis or major arterial invasion based on imaging studies
Key exclusion criteria -MBO on hilum
-Previous endoscopic biliary drainage or percutaneous transhepatic biliary drainage
-Combined cholecystitis or pancreatitis
-Surgically altered anatomy
-Not underwent operation due to comorbidity, neoadjuvant chemotherapy, refusal or follow-up loss
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jong Ho Moon
Organization SoonChunHyang University School of Medicine
Division name Digestive Disease Center and Research Institute
Zip code
Address 170 Jomaru-ro, Bucheon-si, Gyenggi-do, Korea
TEL +821087153543
Email jhmoon@schmc.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Hyun Woo Lee
Organization SoonChunHyang University School of Medicine
Division name Digestive Disease Center and Research Institute
Zip code
Address 170 Jomaru-ro, Bucheon-si, Gyenggi-do, Korea
TEL +821080235271
Homepage URL
Email imlhw@schmc.ac.kr

Sponsor
Institute SoonChunHyang University School of Medicine
Digestive Disease Center and Research Institute
Institute
Department

Funding Source
Organization SoonChunHyang University School of Medicine
Digestive Disease Center and Research Institute
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
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 SoonChunHyang University hospital (Bucheon)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 31 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 Enrolling by invitation
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 30 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034497

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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