Biliary Tract Neoplasms, Jaundice, Obstructive, Pancreatic Neoplasms
Conditions
Keywords
Stents, Stent-graft, Minimally invasive, Biliary Tract Cancer, Pancreatic Cancer, Jaundice, Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive, Zilver
Brief summary
This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive jaundice.
Detailed description
This research is being done to determine if the new, FDA-cleared Zilver metal biliary stent is better than the conventional stents. The new Zilver stent may permit more accurate placement, may avoid some potential complications and last longer than the conventional stents. The study will also examine to find the best diameter of stent by comparing standard 10 mm stents to 6 mm Zilver stents.
Interventions
DEVICE6 mm Nitinol Zilver Stent
DEVICE10 mm Nitinol Zilver Stent
DEVICE10 mm Stainless Steel Wallstent
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unresectable malignancy of the extrahepatic bile duct
Exclusion criteria
* Age below 21 years * Pregnancy * Active alcohol or drug abuse * Simultaneously participating in another investigational drug or device study. * Allergy to stainless steel or nitinol * Active cholangitis * Brachytherapy * Unable or unwilling to comply with follow up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency | up to 32 months | Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (\>= 6 months after placement). |
| Closure or Blockage of the Stent (Occlusion) | up to 32 months | Biliary stents may become closed or blocked. This is also termed Occlusion. Data for this outcome measure involve stent occlusions that required re-intervention. |
| Number of Days to Occlusion | up to 32 months | — |
| Number of Deaths | up to 32 months | — |
| Time to Death | up to 32 months | Overall Survival |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 6 mm Zilver 6 mm Nitinol Zilver Stent | 64 |
| 10 mm Zilver 10 mm Nitinol Zilver Stent | 88 |
| 10 mm Wallstent 10 mm Stainless Steel Wallstent | 89 |
| Total | 241 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 5 | 7 |
Baseline characteristics
| Characteristic | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent | Total |
|---|---|---|---|---|
| Age Continuous | 71.3 Years | 72.8 Years | 71.5 Years | 71.9 Years |
| Biliary Sphincterotomy Patients with Biliary Sphincterotomy | 39 Participants | 50 Participants | 49 Participants | 138 Participants |
| Biliary Sphincterotomy Patients without Biliary Sphincterotomy | 25 Participants | 38 Participants | 40 Participants | 103 Participants |
| Bilirubin | 9.6 mg/dL STANDARD_DEVIATION 8.7 | 8.7 mg/dL STANDARD_DEVIATION 7.3 | 8.3 mg/dL STANDARD_DEVIATION 8.7 | 8.8 mg/dL STANDARD_DEVIATION 8.2 |
| Karnofsky Index | 80.5 Units on a Scale STANDARD_DEVIATION 9.5 | 80.6 Units on a Scale STANDARD_DEVIATION 9.9 | 81.2 Units on a Scale STANDARD_DEVIATION 9.2 | 80.8 Units on a Scale STANDARD_DEVIATION 9.5 |
| Previous Plastic Stent Patients without Previous Plastic Stent | 32 Participants | 53 Participants | 42 Participants | 127 Participants |
| Previous Plastic Stent Patients with Previous Plastic Stent | 32 Participants | 35 Participants | 47 Participants | 114 Participants |
| Sex: Female, Male Female | 27 Participants | 43 Participants | 45 Participants | 115.0 Participants |
| Sex: Female, Male Male | 37 Participants | 45 Participants | 44 Participants | 126.0 Participants |
| Tumor Diagnosis Patients with Cholangiocarcinoma | 7 Participants | 5 Participants | 5 Participants | 17 Participants |
| Tumor Diagnosis Patients with Gallbladder Cancer | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Tumor Diagnosis Patients with Metastatic Cancer | 4 Participants | 12 Participants | 8 Participants | 24 Participants |
| Tumor Diagnosis Patients with Other Cancer | 3 Participants | 7 Participants | 3 Participants | 13 Participants |
| Tumor Diagnosis Patients without Tumor | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Tumor Diagnosis Patients with Pancreatic Cancer | 48 Participants | 63 Participants | 70 Participants | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Closure or Blockage of the Stent (Occlusion)
Biliary stents may become closed or blocked. This is also termed Occlusion. Data for this outcome measure involve stent occlusions that required re-intervention.
Time frame: up to 32 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 6 mm Zilver | Closure or Blockage of the Stent (Occlusion) | 25 Stent Occlusions |
| 10 mm Zilver | Closure or Blockage of the Stent (Occlusion) | 21 Stent Occlusions |
| 10 mm Wallstent | Closure or Blockage of the Stent (Occlusion) | 19 Stent Occlusions |
p-value: 0.04Chi-squared
p-value: 0.007Log Rank
p-value: 0.69Chi-squared
Comparison: 6 mm Zilver vs. 10 mm Zilver and 10 mm Wallstent combinedp-value: 0.02Chi-squared
Primary
Number of Days to Occlusion
Time frame: up to 32 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 6 mm Zilver | Number of Days to Occlusion | 115 Days |
| 10 mm Zilver | Number of Days to Occlusion | 111 Days |
| 10 mm Wallstent | Number of Days to Occlusion | 103 Days |
p-value: 0.16ANOVA
Primary
Number of Deaths
Time frame: up to 32 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 6 mm Zilver | Number of Deaths | 4 Participants |
| 10 mm Zilver | Number of Deaths | 6 Participants |
| 10 mm Wallstent | Number of Deaths | 2 Participants |
Primary
Patency
Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (\>= 6 months after placement).
Time frame: up to 32 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 6 mm Zilver | Patency | 110 Days |
| 10 mm Zilver | Patency | 125.5 Days |
| 10 mm Wallstent | Patency | 121 Days |
p-value: 0.057Log Rank
Primary
Time to Death
Overall Survival
Time frame: up to 32 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 6 mm Zilver | Time to Death | 132.6 Days |
| 10 mm Zilver | Time to Death | 186 Days |
| 10 mm Wallstent | Time to Death | 170 Days |
p-value: 0.32Log Rank
p-value: 0.69Kruskal-Wallis