UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030200 |
|---|---|
| Receipt number | 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 20:18:06 |
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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
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
imlhw@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University School of Medicine
Digestive Disease Center and Research Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034497
