Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 mm Zilver | Experimental | 6 mm Nitinol Zilver Stent |
|
| 10 mm Zilver | Experimental | 10 mm Nitinol Zilver Stent |
|
| 10 mm Wallstent | Active Comparator | 10 mm Stainless Steel Wallstent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6 mm Nitinol Zilver Stent | Device |
| ||
| 10 mm Nitinol Zilver Stent |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | up to 32 months |
| Number of Days to Occlusion | up to 32 months | |
| Number of Deaths | up to 32 months | |
| Time to Death | Overall Survival | up to 32 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Douglas Howell, M.D. | MaineHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maine Medical Center | Portland | Maine | 04102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19482279 | Result | Loew BJ, Howell DA, Sanders MK, Desilets DJ, Kortan PP, May GR, Shah RJ, Chen YK, Parsons WG, Hawes RH, Cotton PB, Slivka AA, Ahmad J, Lehman GA, Sherman S, Neuhaus H, Schumacher BM. Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial. Gastrointest Endosc. 2009 Sep;70(3):445-53. doi: 10.1016/j.gie.2008.11.018. Epub 2009 May 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 6 mm Zilver | 6 mm Nitinol Zilver Stent |
| FG001 | 10 mm Zilver | 10 mm Nitinol Zilver Stent |
| FG002 | 10 mm Wallstent | 10 mm Stainless Steel Wallstent |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 6 mm Zilver | 6 mm Nitinol Zilver Stent |
| BG001 | 10 mm Zilver | 10 mm Nitinol Zilver Stent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | 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). | Posted | Median | Full Range | Days | up to 32 months |
|
Not provided
No adverse events were captured due to terminal patients.
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 | 6 mm Zilver | 6 mm Nitinol Zilver Stent |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Snyder | Cook | 765-463-7537 | ssnyder@medinst.com |
Not provided
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D041781 | Jaundice, Obstructive |
| D007565 | Jaundice |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 10 mm Stainless Steel Wallstent | Device |
|
| BG002 |
| 10 mm Wallstent |
10 mm Stainless Steel Wallstent |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Biliary Sphincterotomy | Number | Participants |
|
| Previous Plastic Stent | Number | Participants |
|
| Tumor Diagnosis | Number | Participants |
|
| Bilirubin | Mean | Standard Deviation | mg/dL |
|
| Karnofsky Index | The Karnofsky index runs from 100 to 0, where 100 is "perfect" health and 0 is death. | Mean | Standard Deviation | Units on a Scale |
|
|
|
|
| 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. | Posted | Number | Stent Occlusions | up to 32 months |
|
|
|
|
| Primary | Number of Days to Occlusion | Posted | Median | Full Range | Days | up to 32 months |
|
|
|
|
| Primary | Number of Deaths | Posted | Number | Participants | up to 32 months |
|
|
|
| Primary | Time to Death | Overall Survival | Posted | Median | Inter-Quartile Range | Days | up to 32 months |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 10 mm Zilver | 10 mm Nitinol Zilver Stent | 0 | 0 | 0 | 0 |
| EG002 | 10 mm Wallstent | 10 mm Stainless Steel Wallstent | 0 | 0 | 0 | 0 |
Not provided
| D004066 |
| Digestive System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Death is censored for Kaplan-Meier analysis.
| 95 |
| No |
| Superiority or Other |
| Chi-squared | .69 | 95 | No | Superiority or Other |
| 6 mm Zilver vs. 10 mm Zilver and 10 mm Wallstent combined | Chi-squared | .02 | P-value is adjusted for multiple comparisons. | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |