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WallFlex Biliary Post Liver Transplant IDE Pilot

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ClinicalTrials.gov Identifier: NCT01151280
Recruitment Status : Completed
First Posted : June 28, 2010
Results First Posted : July 19, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anastomotic Biliary Stricture Post Orthotopic Liver Transplant
Intervention Device: WallFlex Biliary Fully Covered Stent
Enrollment 10
Recruitment Details Patients who signed an informed consent form and met the inclusion/exclusion criteria for this study were enrolled. The first subject was enrolled for this study on October 06, 2009 and the last subject was enrolled on February 01, 2012.
Pre-assignment Details  
Arm/Group Title WallFlex Biliary Fully Covered Stent
Hide Arm/Group Description Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
Period Title: Overall Study
Started 10
Completed 6
Not Completed 4
Reason Not Completed
Adverse Event             1
Lack of Efficacy             3
Arm/Group Title WallFlex Biliary Fully Covered Stent
Hide Arm/Group Description Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
All participants were included for analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
57.6  (5.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Stricture Resolution at the Time of Stent Removal.
Hide Description Stricture resolution is assessed at the time of stent removal. Stricture resolution is confirmed by cholangiogram and/or balloon sweep of the biliary duct. Stent removal can be per-protocol (3 months indwell) or early.
Time Frame At 3 months (per protocol removal) or at early removal.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included for analysis.
Arm/Group Title WallFlex Biliary Fully Covered Stent
Hide Arm/Group Description:
Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
Participants with resolution at removal 9
Participants without resolution at removal 1
2.Secondary Outcome
Title Safety
Hide Description

Safety is being measured by the occurrence, severity, device- and procedure-relatedness of adverse events during stent placement, during stent indwell, at the time of stent removal, and after stent removal.

Unit of measure will be the actual number of adverse events that occurred.

Time Frame From enrollment through end of study.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included for analysis.
Arm/Group Title WallFlex Biliary Fully Covered Stent
Hide Arm/Group Description:
Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: adverse events
Device Related Adverse Event 2
Placement Procedure Related Adverse Event 2
Removal Procedure Related Adverse Events 0
3.Secondary Outcome
Title Stent Removability
Hide Description Stent removability is measured as the ability to successfully remove the stent at initial placement in case of inadequate stent placement, during the stent indwell period in case of stent failure, or at the end of indwell without any clinically significant complications or technical difficulties. A clinically significant complication is defined as a medical event that requires an intervention.
Time Frame At 3 months (per protocol removal) or early removal
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included for analysis.
Arm/Group Title WallFlex Biliary Fully Covered Stent
Hide Arm/Group Description:
Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
Successful Removal 9
Stent not removed due to migration out of duct 1
4.Secondary Outcome
Title Technical Success of Stent Placement
Hide Description Evaluation of technical success of the stent placement defined as the ability to deploy the stent in satisfactory position across the stricture as determined by cholangiogram.
Time Frame At stent placement (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included for analysis.
Arm/Group Title WallFlex Biliary Fully Covered Stent
Hide Arm/Group Description:
Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
Technical Success Achieved 10
Technical Success Not Achieved 0
5.Secondary Outcome
Title Effectiveness of Stent at 6 Months
Hide Description

Evaluation of effectiveness of the stent by assessing for resolution of stricture at 6 months as determined by cholangiogram.

"Effectiveness" is defined as the absence of biliary obstructive symptoms after receiving a WallFlex stent.

Subjects received liver function tests at the 1 Month and 6 Month post stent removal follow-up visits and were also assessed for biliary obstructive symptoms.

Time Frame From stent removal through 6 months post stent removal follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness was assessed in 9 participants that had stricture resolution at the time of stent removal. 1 participant did not have resolution at removal and therefore could not be assessed in the post stent removal follow-up period.
Arm/Group Title WallFlex Biliary Fully Covered Stent
Hide Arm/Group Description:
Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
Maintained Resolution 6 Months Post Removal 6
Recurrence of Biliary Stricture 2
Discontinued due to Unrelated Adverse Event 1
6.Secondary Outcome
Title Re-intervention Occurrence
Hide Description Evaluation of the occurrence of re-intervention. Re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage during stent indwell or through 6 months of follow-up after stent removal.
Time Frame 6 months post stent removal
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included for analysis.
Arm/Group Title WallFlex Biliary Fully Covered Stent
Hide Arm/Group Description:
Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
No Reintervention 4
Endoscopic Reintervention - Stent Removed 2
Endoscopic Reintervention - Re-stented 2
Endo Reintervention - Stent Removed and Re-stented 1
Percutaneous Reintervention - Drainage 1
7.Secondary Outcome
Title Time to Stent Occlusion
Hide Description

Evidence of stent occlusion

"stent occlusion" was assessed during the stent indwell period (from stent placement procedure through the stent removal procedure. 3 months according to protocol). Subjects received liver function tests at the 48 hour, Week 1, Month 1, and Month 3 stent indwell follow-up visits and were also asked if they were experiencing biliary obstructive symptoms at each visit. If stent occlusion was suspected, imaging and/or endoscopic intervention was performed. One subject experienced stent occlusion at 68 days post stent placement. Time to event data was not generated as not enough events occurred to calculate medial time to event data.

Time Frame mean time from stent placement to stent removal for all 10 patients was 91.3 days.
Hide Outcome Measure Data
Hide Analysis Population Description

All participants were included for analysis.

1/10 subjects experienced stent occlusion at 68 days post stent placement. Mean time to event data was not calculated as only 1 stent occlusion occurred in 10 subjects.

Arm/Group Title WallFlex Biliary Fully Covered Stent
Hide Arm/Group Description:
Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: days
68
Time Frame Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title WallFlex Biliary Fully Covered Stent
Hide Arm/Group Description Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
All-Cause Mortality
WallFlex Biliary Fully Covered Stent
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
WallFlex Biliary Fully Covered Stent
Affected / at Risk (%) # Events
Total   6/10 (60.00%)    
Blood and lymphatic system disorders   
Hyponatremia [1]  1/10 (10.00%)  1
Hepatobiliary disorders   
General abdominal pain [2]  1/10 (10.00%)  1
Post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis [2]  1/10 (10.00%)  1
Elevated bilirubin [3]  1/10 (10.00%)  1
Recurrence of biliary stricture [4]  2/10 (20.00%)  2
Altered mental status [1]  1/10 (10.00%)  1
Cholangitis [1]  1/10 (10.00%)  1
Elevated liver enzymes [1]  1/10 (10.00%)  1
Metabolism and nutrition disorders   
Anemia [1]  1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Hip fracture [1]  1/10 (10.00%)  1
Renal and urinary disorders   
Acute renal failure [1]  1/10 (10.00%)  1
Vascular disorders   
Hepatic artery thrombosis [1]  1/10 (10.00%)  1
Pulmonary vascular congestion [1]  1/10 (10.00%)  1
[1]
Unrelated
[2]
Related to stent placement procedure
[3]
Related to device
[4]
Recurrence of biliary stricture was an adverse event that occurred in 2 participants. Both adverse events were unrelated.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
WallFlex Biliary Fully Covered Stent
Affected / at Risk (%) # Events
Total   5/10 (50.00%)    
Hepatobiliary disorders   
Right upper quadrant pain [1]  2/10 (20.00%)  2
Dark urine [2]  1/10 (10.00%)  1
Pale stools [2]  1/10 (10.00%)  1
Itching [3]  3/10 (30.00%)  3
[1]
This AE occurred in 2 participants. One occurrence was related to the device The second occurrence was unrelated
[2]
Unrelated
[3]
This AE occurred in 3 participants. All 3 occurrences were unrelated
This was a small, pilot, feasibility study. Further prospective studies are needed to optimize duration of fully covered self-expanding metal stent indwell and assess predictors of treatment success.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Alexis James, Clinical Project Manager
Organization: Boston Scientific Corporation
Phone: 508-683-4074
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01151280     History of Changes
Other Study ID Numbers: E7055
E7055 ( Other Identifier: Boston Scientific )
First Submitted: June 21, 2010
First Posted: June 28, 2010
Results First Submitted: April 12, 2013
Results First Posted: July 19, 2013
Last Update Posted: December 25, 2013