An interventional study of 6 mm Nitinol Zilver Stent and 10 mm Nitinol Zilver Stent in Biliary Tract Neoplasms, Pancreatic Neoplasms and Jaundice, Obstructive, sponsored by Cook Group Incorporated. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2011-10-03.
Sponsored by Cook Group Incorporated · Not applicable, Interventional, and Treatment
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 241 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Cook Group Incorporated is the lead sponsor of 73 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 mm Nitinol Zilver Stent
Device: 6 mm Nitinol Zilver Stent
10 mm Nitinol Zilver Stent
Device: 10 mm Nitinol Zilver Stent
10 mm Stainless Steel Wallstent
Device: 10 mm Stainless Steel Wallstent
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
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
Number of Days to Occlusion
Time frame: up to 32 months
Number of Deaths
Time frame: up to 32 months
Time to Death
Overall Survival
Time frame: up to 32 months
| Milestone | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent |
|---|---|---|---|
| Started | 64 | 88 | 89 |
| Completed | 60 | 83 | 82 |
| Not completed | 4 | 5 | 7 |
| Withdrew: Lost to follow-up | 4 | 5 | 7 |
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).
| Days | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent |
|---|---|---|---|
| Patency | 110 (7 to 595) | 125.5 (5 to 671) | 121 (0 to 961) |
Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.
| Stent Occlusions | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent |
|---|---|---|---|
| Closure or Blockage of the Stent (Occlusion) | 25 | 21 | 19 |
| Days | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent |
|---|---|---|---|
| Number of Days to Occlusion | 115 (7 to 595) | 111 (6 to 506) | 103 (7 to 386) |
| Participants | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent |
|---|---|---|---|
| Number of Deaths | 4 | 6 | 2 |
Overall Survival
| Days | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent |
|---|---|---|---|
| Time to Death | 132.6 (74 to 328) | 186 (92 to 304) | 170 (99 to 273) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 6 mm Zilver | — | — | — |
| 10 mm Zilver | — | — | — |
| 10 mm Wallstent | — | — | — |
| Age Continuous(Years) | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent | Total |
|---|---|---|---|---|
| Mean | 71.3 (41 to 90) | 72.8 (48 to 94) | 71.5 (49 to 96) | 71.9 (41 to 96) |
| Sex: Female, Male(Participants) | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent | Total |
|---|---|---|---|---|
| Female | 27 | 43 | 45 | 115.0 |
| Male | 37 | 45 | 44 | 126.0 |
| Biliary Sphincterotomy(Participants) | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent | Total |
|---|---|---|---|---|
| Patients with Biliary Sphincterotomy | 39 | 50 | 49 | 138 |
| Patients without Biliary Sphincterotomy | 25 | 38 | 40 | 103 |
| Previous Plastic Stent(Participants) | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent | Total |
|---|---|---|---|---|
| Patients with Previous Plastic Stent | 32 | 35 | 47 | 114 |
| Patients without Previous Plastic Stent | 32 | 53 | 42 | 127 |
| Tumor Diagnosis(Participants) | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent | Total |
|---|---|---|---|---|
| Patients with Pancreatic Cancer | 48 | 63 | 70 | 181 |
| Patients with Metastatic Cancer | 4 | 12 | 8 | 24 |
| Patients with Cholangiocarcinoma | 7 | 5 | 5 | 17 |
| Patients with Gallbladder Cancer | 1 | 0 | 2 | 3 |
| Patients with Other Cancer | 3 | 7 | 3 | 13 |
| Patients without Tumor | 1 | 1 | 1 | 3 |
| Bilirubin(mg/dL) | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent | Total |
|---|---|---|---|---|
| Mean | 9.6 ± 8.7 | 8.7 ± 7.3 | 8.3 ± 8.7 | 8.8 ± 8.2 |
| Karnofsky Index(Units on a Scale) | 6 mm Zilver | 10 mm Zilver | 10 mm Wallstent | Total |
|---|---|---|---|---|
| Mean | 80.5 ± 9.5 | 80.6 ± 9.9 | 81.2 ± 9.2 | 80.8 ± 9.5 |
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Cook Group Incorporated