Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-02188 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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 purpose of this study is to assess the impact of temperature-sensitive radiofrequency ablation (RFA) immediately before biliary stent placement on duration of biliary stent patency and re-intervention free survival. This is a research study meant to collect information to help other patients with malignant biliary strictures in the future.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temperature-sensitive RFA prior to biliary stenting | Data will be collected on subjects undergoing endoscopic retrograde cholangiopancreatography (ERCP) with temperature-sensitive RFA prior to biliary stenting for treatment of malignant biliary strictures as part of clinical care. |
| |
| Non-RFA biliary stenting for malignant biliary obstruction | Retrospective participants that have undergone non-RFA biliary stenting for malignant biliary obstruction from a historical cohort will serve as controls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temperature-sensitive radiofrequency ablation | Procedure | Endobiliary radiofrequency ablation prior to ERCP-guided biliary stenting that utilizes a temperature-sensitive endobiliary RFA catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Stent patency | Duration of stent patency over the 6 month follow-up period | 6 months |
| Re-intervention free survival | Duration of re-intervention free survival over the 6 month follow-up period | 6 months |
| Mortality | Number of subject deaths following ERCP, over the 6-month follow-up period | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants with treatment-related adverse events over the 6-month follow-up period | 6 months |
| Time until first adverse event | Time (in days) from ERCP until first treatment-related adverse event, over the 6-month follow-up period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients that have or will have a biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation (RFA) with placement of biliary stents.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vinay Chandrasekhara, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| No intervention | Other | No intervention |
|
| 6 months |