Trial Outcomes & Findings for Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures (NCT NCT01221311)
NCT ID: NCT01221311
Last Updated: 2017-06-02
Results Overview
Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
Post-stent removal (up to one year after enrollment)
Results posted on
2017-06-02
Participant Flow
Participant milestones
| Measure |
Fully Covered Metallic Stent
Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.
Fully covered Metallic Stent: Covered Wallflex Biliary (TM)
|
Plastic Stent
Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).
Plastic Stent: Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
55
|
|
Overall Study
COMPLETED
|
57
|
55
|
|
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 |
Fully Covered Metallic Stent
n=57 Participants
Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.
Fully covered Metallic Stent: Covered Wallflex Biliary (TM)
|
Plastic Stent
n=55 Participants
Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 10.4 • n=57 Participants
|
56.7 years
STANDARD_DEVIATION 11 • n=55 Participants
|
55.9 years
STANDARD_DEVIATION 10.7 • n=112 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=57 Participants
|
17 Participants
n=55 Participants
|
36 Participants
n=112 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=57 Participants
|
38 Participants
n=55 Participants
|
76 Participants
n=112 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Post-stent removal (up to one year after enrollment)Population: The number of participants analyzed is lower than the number of patients randomized, due to patients who dropped out of the study before all stents were removed.
Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group.
Outcome measures
| Measure |
Fully Covered Metallic Stent
n=54 Participants
Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.
Fully covered Metallic Stent: Covered Wallflex Biliary (TM)
|
Plastic Stent
n=48 Participants
Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).
Plastic Stent: Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal
|
|---|---|---|
|
Early Clinical Success
|
50 Participants
|
41 Participants
|
Adverse Events
Fully Covered Metallic Stent
Serious events: 14 serious events
Other events: 8 other events
Deaths: 0 deaths
Plastic Stent
Serious events: 9 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fully Covered Metallic Stent
n=57 participants at risk
Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.
Fully covered Metallic Stent: Covered Wallflex Biliary (TM)
|
Plastic Stent
n=55 participants at risk
Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria.
|
|---|---|---|
|
Gastrointestinal disorders
Stent migration
|
24.6%
14/57 • Number of events 16
|
16.4%
9/55 • Number of events 10
|
Other adverse events
| Measure |
Fully Covered Metallic Stent
n=57 participants at risk
Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.
Fully covered Metallic Stent: Covered Wallflex Biliary (TM)
|
Plastic Stent
n=55 participants at risk
Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.0%
8/57 • Number of events 8
|
14.5%
8/55 • Number of events 9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place