Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
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|ClinicalTrials.gov Identifier: NCT01905384|
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : December 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Distal Bile Duct Obstruction||Device: Covered Self-expanding metal biliary stents (C-SEMS) Device: Uncovered Self-expanding metal biliary stents (U-SEMS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction|
|Actual Study Start Date :||November 8, 2017|
|Actual Primary Completion Date :||December 1, 2020|
|Actual Study Completion Date :||December 1, 2020|
Active Comparator: U-SEMS group
Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).
Device: Uncovered Self-expanding metal biliary stents (U-SEMS)
Used for palliation of inoperable malignant distal bile duct obstructions.
Active Comparator: C-SEMS Group
Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)
Device: Covered Self-expanding metal biliary stents (C-SEMS)
Used for palliation of inoperable malignant distal bile duct obstruction.
- Rate of long-term stent failure [ Time Frame: One year ]Compare the rate of long-term stent failure, defined as need for repeat biliary intervention (endoscopic, percutaneous, or surgical) following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
- Rates of adverse stent-related or intervention-related outcomes [ Time Frame: One Year ]Such as pancreatitis, cholangitis, cholecystitis, perforation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905384
|United States, New York|
|Mount Sinai Hospital|
|New York, New York, United States, 10029|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Patrick Yachimski, MD, MPH||Vanderbilt University|