Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| E7055 | Other Identifier | Boston Scientific |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WallFlex Biliary Fully Covered Stent | Experimental | All eligible patients entered into the study will be treated with a WallFlex Biliary Fully Covered Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WallFlex Biliary Fully Covered Stent | Device | Investigational device evaluated for the treatment for benign biliary strictures |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 3 months (per protocol removal) or at early removal. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment through end of study. |
Not provided
Inclusion Criteria:
Age 18 or older
Post -OLT patients with symptoms of biliary obstruction secondary to anastomotic biliary stricture as assessed by:
Willingness and ability to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Divyesh Sejpal, M.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Medical Center | New York | New York | 10017 | United States | ||
| Mansour Parsi, MD |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants were included for analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants were included for analysis. | Posted | Number | participants | At 3 months (per protocol removal) or at early removal. |
|
Adverse events were collected for all participants from the time of informed consent through the final follow-up visit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General abdominal pain | Hepatobiliary disorders | Related to stent placement procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right upper quadrant pain | Hepatobiliary disorders | This AE occurred in 2 participants. One occurrence was related to the device The second occurrence was 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexis James, Clinical Project Manager | Boston Scientific Corporation | 508-683-4074 | jamesa@bsci.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| 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. | 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. | 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. | 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. | mean time from stent placement to stent removal for all 10 patients was 91.3 days. |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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. | All participants were included for analysis. | Posted | Number | adverse events | From enrollment through end of study. |
|
|
|
| Secondary | 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. | All participants were included for analysis. | Posted | Number | participants | At 3 months (per protocol removal) or early removal |
|
|
|
| Secondary | 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. | All participants were included for analysis. | Posted | Number | participants | At stent placement (Day 1) |
|
|
|
| Secondary | 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. | 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. | Posted | Number | participants | From stent removal through 6 months post stent removal follow-up. |
|
|
|
| Secondary | 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. | All participants were included for analysis. | Posted | Number | participants | 6 months post stent removal |
|
|
|
| Secondary | 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. | 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. | Posted | Number | days | mean time from stent placement to stent removal for all 10 patients was 91.3 days. |
|
|
|
| 6 |
| 10 |
| 5 |
| 10 |
| Post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis | Hepatobiliary disorders | Related to stent placement procedure |
|
| Elevated bilirubin | Hepatobiliary disorders | Related to device |
|
| Hip fracture | Musculoskeletal and connective tissue disorders | Unrelated |
|
| Recurrence of biliary stricture | Hepatobiliary disorders | Recurrence of biliary stricture was an adverse event that occurred in 2 participants. Both adverse events were unrelated. |
|
| Altered mental status | Hepatobiliary disorders | Unrelated |
|
| Hyponatremia | Blood and lymphatic system disorders | Unrelated |
|
| Cholangitis | Hepatobiliary disorders | Unrelated |
|
| Hepatic artery thrombosis | Vascular disorders | Unrelated |
|
| Acute renal failure | Renal and urinary disorders | Unrelated |
|
| Anemia | Metabolism and nutrition disorders | Unrelated |
|
| Pulmonary vascular congestion | Vascular disorders | Unrelated |
|
| Elevated liver enzymes | Hepatobiliary disorders | Unrelated |
|
|
| Dark urine | Hepatobiliary disorders | Unrelated |
|
| Pale stools | Hepatobiliary disorders | Unrelated |
|
| Itching | Hepatobiliary disorders | This AE occurred in 3 participants. All 3 occurrences were unrelated |
|
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Endo Reintervention - Stent Removed and Re-stented |
|
| Percutaneous Reintervention - Drainage |
|