An interventional study of WallFlex Biliary Fully Covered Stent in Anastomotic Biliary Stricture Post Orthotopic Liver Transplant, sponsored by Boston Scientific Corporation. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-25.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment
The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients.
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This study's enrollment of 10 is below the median of 80 across 672 interventional studies indexed under Constriction, Pathologic.
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Post -OLT patients with symptoms of biliary obstruction secondary to anastomotic biliary stricture as assessed by:
Exclusion Criteria:
All eligible patients entered into the study will be treated with a WallFlex Biliary Fully Covered Stent
Device: WallFlex Biliary Fully Covered Stent
Investigational device evaluated for the treatment for benign biliary strictures
Stricture Resolution at the Time of Stent Removal.
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.
Safety
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.
Stent Removability
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
Technical Success of Stent Placement
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)
Effectiveness of Stent at 6 Months
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.
Re-intervention Occurrence
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
Time to Stent Occlusion
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.
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.
| Milestone | WallFlex Biliary Fully Covered Stent |
|---|---|
| Started | 10 |
| Completed | 6 |
| Not completed | 4 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lack of efficacy | 3 |
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.
| participants | WallFlex Biliary Fully Covered Stent |
|---|---|
| Participants with resolution at removal | 9 |
| Participants without resolution at removal | 1 |
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.
| adverse events | WallFlex Biliary Fully Covered Stent |
|---|---|
| Device Related Adverse Event | 2 |
| Placement Procedure Related Adverse Event | 2 |
| Removal Procedure Related Adverse Events | 0 |
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.
| participants | WallFlex Biliary Fully Covered Stent |
|---|---|
| Successful Removal | 9 |
| Stent not removed due to migration out of duct | 1 |
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.
| participants | WallFlex Biliary Fully Covered Stent |
|---|---|
| Technical Success Achieved | 10 |
| Technical Success Not Achieved | 0 |
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.
| participants | WallFlex Biliary Fully Covered Stent |
|---|---|
| Maintained Resolution 6 Months Post Removal | 6 |
| Recurrence of Biliary Stricture | 2 |
| Discontinued due to Unrelated Adverse Event | 1 |
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.
| participants | WallFlex Biliary Fully Covered Stent |
|---|---|
| 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 |
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.
| days | WallFlex Biliary Fully Covered Stent |
|---|---|
| Time to Stent Occlusion | 68 |
Collected over Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| WallFlex Biliary Fully Covered Stent | — | 6/10 (60%) | 5/10 (50%) |
| Event | WallFlex Biliary Fully Covered Stent |
|---|---|
| Recurrence of biliary strictureHepatobiliary disorders | 2/10 |
| General abdominal painHepatobiliary disorders | 1/10 |
| Post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitisHepatobiliary disorders | 1/10 |
| Elevated bilirubinHepatobiliary disorders | 1/10 |
| Hip fractureMusculoskeletal and connective tissue disorders | 1/10 |
| Altered mental statusHepatobiliary disorders | 1/10 |
| HyponatremiaBlood and lymphatic system disorders | 1/10 |
| CholangitisHepatobiliary disorders | 1/10 |
| Hepatic artery thrombosisVascular disorders | 1/10 |
| Acute renal failureRenal and urinary disorders | 1/10 |
| Event | WallFlex Biliary Fully Covered Stent |
|---|---|
| ItchingHepatobiliary disorders | 3/10 |
| Right upper quadrant painHepatobiliary disorders | 2/10 |
| Dark urineHepatobiliary disorders | 1/10 |
| Pale stoolsHepatobiliary disorders | 1/10 |
All participants were included for analysis.
| Age, Categorical(Participants) | WallFlex Biliary Fully Covered Stent |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Age, Continuous(years) | WallFlex Biliary Fully Covered Stent |
|---|---|
| Mean | 57.6 ± 5.52 |
| Sex: Female, Male(Participants) | WallFlex Biliary Fully Covered Stent |
|---|---|
| Female | 5 |
| Male | 5 |
| Region of Enrollment(participants) | WallFlex Biliary Fully Covered Stent |
|---|---|
| United States | 10 |
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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