Trial Outcomes & Findings for WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study (NCT NCT01543256)
NCT ID: NCT01543256
Last Updated: 2023-01-09
Results Overview
Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
172 participants
Primary outcome timeframe
After 12-month stenting period through 24 month follow-up (approximately 12 months)
Results posted on
2023-01-09
Participant Flow
Of 172 enrolled participants, 164 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Metal Stents
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
|
Plastic Stents
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
84
|
|
Overall Study
COMPLETED
|
62
|
70
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Metal Stents
n=80 Participants
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
|
Plastic Stents
n=84 Participants
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=80 Participants
|
53 years
n=84 Participants
|
52 years
n=164 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=80 Participants
|
12 Participants
n=84 Participants
|
22 Participants
n=164 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=80 Participants
|
72 Participants
n=84 Participants
|
142 Participants
n=164 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
2 participants
n=80 Participants
|
3 participants
n=84 Participants
|
5 participants
n=164 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=80 Participants
|
6 participants
n=84 Participants
|
11 participants
n=164 Participants
|
|
Region of Enrollment
Austria
|
8 participants
n=80 Participants
|
11 participants
n=84 Participants
|
19 participants
n=164 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=80 Participants
|
2 participants
n=84 Participants
|
5 participants
n=164 Participants
|
|
Region of Enrollment
Belgium
|
13 participants
n=80 Participants
|
13 participants
n=84 Participants
|
26 participants
n=164 Participants
|
|
Region of Enrollment
Hong Kong
|
2 participants
n=80 Participants
|
3 participants
n=84 Participants
|
5 participants
n=164 Participants
|
|
Region of Enrollment
Italy
|
16 participants
n=80 Participants
|
16 participants
n=84 Participants
|
32 participants
n=164 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=80 Participants
|
3 participants
n=84 Participants
|
7 participants
n=164 Participants
|
|
Region of Enrollment
France
|
6 participants
n=80 Participants
|
6 participants
n=84 Participants
|
12 participants
n=164 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=80 Participants
|
1 participants
n=84 Participants
|
2 participants
n=164 Participants
|
|
Region of Enrollment
India
|
20 participants
n=80 Participants
|
20 participants
n=84 Participants
|
40 participants
n=164 Participants
|
|
Time since chronic pancreatitis (CP) diagnosed
|
3.1 years
n=80 Participants
|
1.7 years
n=84 Participants
|
1.9 years
n=164 Participants
|
|
Gallbladder in situ
|
69 Participants
n=80 Participants
|
72 Participants
n=84 Participants
|
141 Participants
n=164 Participants
|
|
CP etiology alcoholic
|
54 Participants
n=71 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
53 Participants
n=78 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
107 Participants
n=149 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
|
Calcifying CP
|
59 Participants
n=74 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
62 Participants
n=80 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
121 Participants
n=154 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
|
Candidate for surgery
|
60 Participants
n=72 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
61 Participants
n=77 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
121 Participants
n=149 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
|
Prior plastic stent
|
34 Participants
n=80 Participants
|
38 Participants
n=84 Participants
|
72 Participants
n=164 Participants
|
|
Prior Biliary Sphincterotomy
|
39 Participants
n=79 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
39 Participants
n=82 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
78 Participants
n=161 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
|
Prior pancreatic sphincterotomy
|
26 Participants
n=79 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
27 Participants
n=82 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
53 Participants
n=161 Participants • The number of analyzed participants are lower than the overall number of baseline participants because of missing data or status unknown.
|
|
Baseline Bilirubin
|
1 mg/dL
n=80 Participants
|
1.4 mg/dL
n=84 Participants
|
1.3 mg/dL
n=164 Participants
|
|
Baseline Alkaline Phosphatase
|
337 IU/L
n=80 Participants
|
262.5 IU/L
n=84 Participants
|
299 IU/L
n=164 Participants
|
PRIMARY outcome
Timeframe: After 12-month stenting period through 24 month follow-up (approximately 12 months)Population: Of 80 participants in metal stent arm, only 62 were eligible for primary endpoint evaluation. Of 84 participants in plastic stent arm, only 70 were eligible for primary endpoint evaluation.
Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.
Outcome measures
| Measure |
Metal Stents
n=62 Participants
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
|
Plastic Stents
n=70 Participants
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
|
|---|---|---|
|
Number of Participants With Stricture Resolution
|
47 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Initial stent placement procedure to 24 month follow-upDevice or procedure related serious adverse events from the initial stent placement procedure to the 24 month follow-up.
Outcome measures
| Measure |
Metal Stents
n=80 Participants
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
|
Plastic Stents
n=84 Participants
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
|
|---|---|---|
|
Serious Adverse Events Related to the Device or Procedure
|
19 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Initial stent placement procedure to 24 month follow-upPopulation: Of 80 participants in metal stent arm, 1 participant failed technical success at baseline and did have a completed ERCP procedure. Of 84 participants in plastic stent arm, 2 participants failed technical success at baseline and did have a completed ERCP procedure.
The number of endoscopic retrograde cholangiopancreatography (ERCP) procedures through 24 months, after initial stent placement.
Outcome measures
| Measure |
Metal Stents
n=79 Participants
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
|
Plastic Stents
n=82 Participants
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
|
|---|---|---|
|
Number of ERCP Procedures Through 24 Months After Initial Stent Placement.
|
2.6 procedures
Standard Deviation 1.3
|
3.9 procedures
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Initial stent placement procedureTechnical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure.
Outcome measures
| Measure |
Metal Stents
n=80 Participants
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
|
Plastic Stents
n=84 Participants
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
|
|---|---|---|
|
Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)
|
79 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Initial stent placement procedure to 24 month follow-upLength of stent placement procedures and stent removal procedures.
Outcome measures
| Measure |
Metal Stents
n=192 Procedures
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
|
Plastic Stents
n=302 Procedures
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
|
|---|---|---|
|
Length of Stent Placement and Removal Procedures
|
26 minutes
Interval 3.0 to 182.0
|
28 minutes
Interval 5.0 to 144.0
|
SECONDARY outcome
Timeframe: Initial stent placement procedure to 24 month follow-upPopulation: Of 80 participants in metal stent arm, 1 participant never had a stent placed. Of 84 participants in plastic stent arm, 2 participants never had a stent placed, 1 participant withdrew from the study.
Number of stents placed throughout study to 24 month follow-up
Outcome measures
| Measure |
Metal Stents
n=79 Participants
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
|
Plastic Stents
n=81 Participants
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
|
|---|---|---|
|
Number of Stents Placed
|
2.3 number of stents
Standard Deviation 3.3
|
6.7 number of stents
Standard Deviation 4.4
|
Adverse Events
Metal Stents
Serious events: 19 serious events
Other events: 3 other events
Deaths: 5 deaths
Plastic Stents
Serious events: 16 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Metal Stents
n=80 participants at risk
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
|
Plastic Stents
n=84 participants at risk
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
|
|---|---|---|
|
Gastrointestinal disorders
Acute-on-chronic pancreatitis
|
2.5%
2/80 • 24 months
|
0.00%
0/84 • 24 months
|
|
Gastrointestinal disorders
Perforation of duodenum
|
0.00%
0/80 • 24 months
|
1.2%
1/84 • 24 months
|
|
Gastrointestinal disorders
Post-sphincterotomy bleed
|
1.3%
1/77 • 24 months
|
0.00%
0/76 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
5/80 • 24 months
|
6.0%
5/84 • 24 months
|
|
Gastrointestinal disorders
Cholangitis/fever/jaundice
|
8.8%
7/80 • 24 months
|
10.7%
9/84 • 24 months
|
|
Gastrointestinal disorders
Cholecystitis
|
4.3%
3/69 • 24 months
|
1.4%
1/72 • 24 months
|
|
Gastrointestinal disorders
Post-ERCP pancreatitis
|
2.5%
2/80 • 24 months
|
0.00%
0/84 • 24 months
|
Other adverse events
| Measure |
Metal Stents
n=80 participants at risk
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
WallFlex™ Biliary RX Fully Covered Stent System RMV: Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
|
Plastic Stents
n=84 participants at risk
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Commercially available Plastic Stent Per Investigator preference: Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
|
|---|---|---|
|
Gastrointestinal disorders
Acute Pancreatitis
|
0.00%
0/80 • 24 months
|
1.2%
1/84 • 24 months
|
|
Gastrointestinal disorders
Upper Respiratory Tract Infection
|
0.00%
0/80 • 24 months
|
1.2%
1/84 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstruction Pulmonary Disease
|
1.2%
1/80 • 24 months
|
0.00%
0/84 • 24 months
|
|
Nervous system disorders
Neuropathy Peripheral
|
1.2%
1/80 • 24 months
|
0.00%
0/84 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
3/80 • 24 months
|
4.8%
4/84 • 24 months
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/80 • 24 months
|
1.2%
1/84 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal Oedema
|
0.00%
0/80 • 24 months
|
1.2%
1/84 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place