Trial Outcomes & Findings for Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction (NCT NCT01905384)
NCT ID: NCT01905384
Last Updated: 2022-03-31
Results Overview
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.
COMPLETED
NA
6 participants
One year
2022-03-31
Participant Flow
Participants were recruited from patient population at the Vanderbilt Digestive Disease Center. Between November 8, 2017 until June 14, 2019, only 6 participants were randomized and completed the study.
4 participants screen failed before being randomized to either arm of the study. Only 6 participants was randomized (3 to each arm) and completed the study.
Participant milestones
| Measure |
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).
Uncovered Self-expanding metal biliary stents (U-SEMS): Used for palliation of inoperable malignant distal bile duct obstructions.
|
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)
Covered Self-expanding metal biliary stents (C-SEMS): Used for palliation of inoperable malignant distal bile duct obstruction.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
U-SEMS Group
n=3 Participants
Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).
Uncovered Self-expanding metal biliary stents (U-SEMS): Used for palliation of inoperable malignant distal bile duct obstructions.
|
C-SEMS Group
n=3 Participants
Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)
Covered Self-expanding metal biliary stents (C-SEMS): Used for palliation of inoperable malignant distal bile duct obstruction.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73 Years
STANDARD_DEVIATION 0 • n=3 Participants
|
73 Years
STANDARD_DEVIATION 0 • n=3 Participants
|
73 Years
STANDARD_DEVIATION 0 • n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
6 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: 3 participants randomized to each arm for a total of 6 participants. Of the 3 participants in the U-SEMS group, none needed repeat intervention. Of the 3 participants in the C-SEMS group, 2 needed repeat intervention.
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.
Outcome measures
| Measure |
U-SEMS Group
n=3 Participants
Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).
Uncovered Self-expanding metal biliary stents (U-SEMS): Used for palliation of inoperable malignant distal bile duct obstructions.
|
C-SEMS Group
n=3 Participants
Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)
Covered Self-expanding metal biliary stents (C-SEMS): Used for palliation of inoperable malignant distal bile duct obstruction.
|
|---|---|---|
|
Rate of Long-term Stent Failure
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: One YearPopulation: 3 participants randomized to each arm for a total of 6 participants. Of the 3 participants in the U-SEMS group, there were no reports of pancreatitis, cholangitis, cholecystitis, or perforation. Of the 3 participants in the C-SEMS group, there were no reports of pancreatitis, cholangitis, cholecystitis, or perforation.
Participants will be monitored for adverse stent-related or intervention-related outcomes such as pancreatitis, cholangitis, cholecystitis, perforation.
Outcome measures
| Measure |
U-SEMS Group
n=3 Participants
Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).
Uncovered Self-expanding metal biliary stents (U-SEMS): Used for palliation of inoperable malignant distal bile duct obstructions.
|
C-SEMS Group
n=3 Participants
Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)
Covered Self-expanding metal biliary stents (C-SEMS): Used for palliation of inoperable malignant distal bile duct obstruction.
|
|---|---|---|
|
Rates of Adverse Stent-related or Intervention-related Outcomes
|
0 Participants
|
0 Participants
|
Adverse Events
U-SEMS Group
C-SEMS Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sharee Burkeen, Research Program Manager
Vanderbilt University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place