Anastomotic Biliary Stricture Post Orthotopic Liver Transplant
Conditions
Brief summary
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.
Interventions
DEVICEWallFlex Biliary Fully Covered Stent
Investigational device evaluated for the treatment for benign biliary strictures
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older 2. Post -OLT patients with symptoms of biliary obstruction secondary to anastomotic biliary stricture as assessed by: * Clinical signs and symptoms including jaundice, abdominal pain, pruritis, and cholangitis * Abnormal liver function tests (serum bilirubin \> 1.5 and/or elevated alkaline phosphatase levels) * Abnormal imaging on ultrasound, CT scan, or MRCP suggestive of a biliary stricture 3. Willingness and ability to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion criteria
1. Roux-en-Y choledochojejunostomy 2. Suspected nonanastomotic biliary strictures based on imaging(i.e. multiple strictures, strictures that are longer than 8cm in length, strictures located in the intrahepatic ducts and/or in the donor duct proximal to the site of anastomosis) 3. Living donor transplants 4. Transplants performed within 30 days (fresh transplants) 5. Perforation of any duct within the biliary tree 6. Patients with known sensitivity to any components of the stent or delivery system 7. Patients with malignancy involving the biliary tree (including hepatocellular carcinoma) 8. Patients with poor Karnofsky score 9. Life expectancy of less than one year 10. Inability to pass a guidewire through the strictured area 11. Previous biliary metal or multiple plastic stent placement 12. Drug-induced or cholestatic hepatitis from an infective cause 13. Redundant bile duct that may be treated by temporary placement of stent or conversion to a RouxEnY hepaticojejunostomy 14. Choledocholithiasis/biliary cast syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stricture Resolution at the Time of Stent Removal. | At 3 months (per protocol removal) or at early 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent Removability | At 3 months (per protocol removal) or early removal | 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. |
| Technical Success of Stent Placement | At stent placement (Day 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. |
| Safety | From enrollment through end of study. | 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. |
| Re-intervention Occurrence | 6 months post stent removal | 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 to Stent Occlusion | mean time from stent placement to stent removal for all 10 patients was 91.3 days. | 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. |
| Effectiveness of Stent at 6 Months | From stent removal through 6 months post stent removal follow-up. | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 3 |
Baseline characteristics
| Characteristic | WallFlex Biliary Fully Covered Stent |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 57.6 years STANDARD_DEVIATION 5.52 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 10 |
| serious Total, serious adverse events | 6 / 10 |
Outcome results
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.
Time frame: At 3 months (per protocol removal) or at early removal.
Population: All participants were included for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WallFlex Biliary Fully Covered Stent | Stricture Resolution at the Time of Stent Removal. | Participants with resolution at removal | 9 participants |
| WallFlex Biliary Fully Covered Stent | Stricture Resolution at the Time of Stent Removal. | Participants without resolution at removal | 1 participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WallFlex Biliary Fully Covered Stent | Effectiveness of Stent at 6 Months | Maintained Resolution 6 Months Post Removal | 6 participants |
| WallFlex Biliary Fully Covered Stent | Effectiveness of Stent at 6 Months | Recurrence of Biliary Stricture | 2 participants |
| WallFlex Biliary Fully Covered Stent | Effectiveness of Stent at 6 Months | Discontinued due to Unrelated Adverse Event | 1 participants |
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.
Time frame: 6 months post stent removal
Population: All participants were included for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WallFlex Biliary Fully Covered Stent | Re-intervention Occurrence | No Reintervention | 4 participants |
| WallFlex Biliary Fully Covered Stent | Re-intervention Occurrence | Endoscopic Reintervention - Stent Removed | 2 participants |
| WallFlex Biliary Fully Covered Stent | Re-intervention Occurrence | Endoscopic Reintervention - Re-stented | 2 participants |
| WallFlex Biliary Fully Covered Stent | Re-intervention Occurrence | Endo Reintervention - Stent Removed and Re-stented | 1 participants |
| WallFlex Biliary Fully Covered Stent | Re-intervention Occurrence | Percutaneous Reintervention - Drainage | 1 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.
Time frame: From enrollment through end of study.
Population: All participants were included for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WallFlex Biliary Fully Covered Stent | Safety | Device Related Adverse Event | 2 adverse events |
| WallFlex Biliary Fully Covered Stent | Safety | Placement Procedure Related Adverse Event | 2 adverse events |
| WallFlex Biliary Fully Covered Stent | Safety | Removal Procedure Related Adverse Events | 0 adverse events |
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.
Time frame: At 3 months (per protocol removal) or early removal
Population: All participants were included for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WallFlex Biliary Fully Covered Stent | Stent Removability | Successful Removal | 9 participants |
| WallFlex Biliary Fully Covered Stent | Stent Removability | Stent not removed due to migration out of duct | 1 participants |
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.
Time frame: At stent placement (Day 1)
Population: All participants were included for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WallFlex Biliary Fully Covered Stent | Technical Success of Stent Placement | Technical Success Achieved | 10 participants |
| WallFlex Biliary Fully Covered Stent | Technical Success of Stent Placement | Technical Success Not Achieved | 0 participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Time to Stent Occlusion | 68 days |