Trial Outcomes & Findings for WallFlex Biliary Post Liver Transplant IDE Pilot (NCT NCT01151280)

Last Updated: 2013-12-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

At 3 months (per protocol removal) or at early removal.

Results posted on

2013-12-25

Participant Flow

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.

Participant milestones

Participant milestones
Measure	WallFlex Biliary Fully Covered Stent 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 Study STARTED	10
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	WallFlex Biliary Fully Covered Stent 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 Study Adverse Event	1
Overall Study Lack of Efficacy	3

Baseline Characteristics

WallFlex Biliary Post Liver Transplant IDE Pilot

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	WallFlex Biliary Fully Covered Stent n=10 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	57.6 years STANDARD_DEVIATION 5.52 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: At 3 months (per protocol removal) or at early removal.

Population: All participants were included for analysis.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=10 Participants 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.
Stricture Resolution at the Time of Stent Removal. Participants with resolution at removal	9 participants
Stricture Resolution at the Time of Stent Removal. Participants without resolution at removal	1 participants

SECONDARY outcome

Timeframe: From enrollment through end of study.

Population: All participants were included for analysis.

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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=10 Participants 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.
Safety Device Related Adverse Event	2 adverse events
Safety Placement Procedure Related Adverse Event	2 adverse events
Safety Removal Procedure Related Adverse Events	0 adverse events

SECONDARY outcome

Timeframe: At 3 months (per protocol removal) or early removal

Population: All participants were included for analysis.

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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=10 Participants 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.
Stent Removability Successful Removal	9 participants
Stent Removability Stent not removed due to migration out of duct	1 participants

SECONDARY outcome

Timeframe: At stent placement (Day 1)

Population: All participants were included for analysis.

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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=10 Participants 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.
Technical Success of Stent Placement Technical Success Achieved	10 participants
Technical Success of Stent Placement Technical Success Not Achieved	0 participants

SECONDARY outcome

Timeframe: From stent removal through 6 months post stent removal follow-up.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=9 Participants 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.
Effectiveness of Stent at 6 Months Maintained Resolution 6 Months Post Removal	6 participants
Effectiveness of Stent at 6 Months Recurrence of Biliary Stricture	2 participants
Effectiveness of Stent at 6 Months Discontinued due to Unrelated Adverse Event	1 participants

SECONDARY outcome

Timeframe: 6 months post stent removal

Population: All participants were included for analysis.

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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=10 Participants 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.
Re-intervention Occurrence No Reintervention	4 participants
Re-intervention Occurrence Endoscopic Reintervention - Stent Removed	2 participants
Re-intervention Occurrence Endoscopic Reintervention - Re-stented	2 participants
Re-intervention Occurrence Endo Reintervention - Stent Removed and Re-stented	1 participants
Re-intervention Occurrence Percutaneous Reintervention - Drainage	1 participants

SECONDARY outcome

Timeframe: mean time from stent placement to stent removal for all 10 patients was 91.3 days.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=10 Participants 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.
Time to Stent Occlusion	68 days

Adverse Events

WallFlex Biliary Fully Covered Stent

Serious events: 6 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	WallFlex Biliary Fully Covered Stent n=10 participants at risk 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.
Hepatobiliary disorders General abdominal pain	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Hepatobiliary disorders Post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Hepatobiliary disorders Elevated bilirubin	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Musculoskeletal and connective tissue disorders Hip fracture	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Hepatobiliary disorders Recurrence of biliary stricture	20.0% 2/10 • Number of events 2 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Hepatobiliary disorders Altered mental status	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Blood and lymphatic system disorders Hyponatremia	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Hepatobiliary disorders Cholangitis	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Vascular disorders Hepatic artery thrombosis	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Renal and urinary disorders Acute renal failure	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Metabolism and nutrition disorders Anemia	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Vascular disorders Pulmonary vascular congestion	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Hepatobiliary disorders Elevated liver enzymes	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.

Other adverse events

Other adverse events
Measure	WallFlex Biliary Fully Covered Stent n=10 participants at risk 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.
Hepatobiliary disorders Right upper quadrant pain	20.0% 2/10 • Number of events 2 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Hepatobiliary disorders Dark urine	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Hepatobiliary disorders Pale stools	10.0% 1/10 • Number of events 1 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Hepatobiliary disorders Itching	30.0% 3/10 • Number of events 3 • Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.

Additional Information

Alexis James, Clinical Project Manager

Boston Scientific Corporation

Phone: 508-683-4074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place