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Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients. However over 50% of the stents get blocked within 6-8 months. Use of the radiofrequency ablation before the stent placement may improve stent patency. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent. The investigators are looking to see how safe and feasible RFA (Radiofrequency ablation) catheter is in patient with malignant bile duct stenosis.
As part of medical care subjects will be undergoing an endoscopic procedure (ERCP) in order to evaluate and stent a bile duct blockage. During the ECRP and just prior to the stent placement subjects will undergo the placement of a radiofrequency ablation catheter into the bile duct blockage. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent; after the radiofrequency ablation, stent will be placed. Three days after the procedure subjects will receive a phone call from the research coordinator to check any adverse or unwanted effects of the treatment. The study procedure (radiofrequency ablation) takes place over 10 minutes during ERCP. The subjects will undergo routine follow up for their medical problems. No follow up visits are required as part of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Radiofrequency ablation catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation catheter (Habib EndoHBP) | Device | Catheter placement into bile duct |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Bile Leak After RFA Procedure | Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Ease of the Radiofrequency Ablation Catheter Placement | Determine the feasibility of radiofrequency ablation catheter placement across malignant strictures with using a subjective scale, 0 is being impossible to place the catheter and 10 is being very easy to place the catheter. | 2 years |
| Effectiveness: Change From Baseline in Bile Duct Diameter. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William R Brugge, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | United States |
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| Label | URL |
|---|---|
| Study information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Safety: Number of Bile Leak After RFA Procedure | Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography) | Posted | Number | bile leak | 2 years |
|
|
2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William R. Brugge | Mass. General Hospital | 617-724-0578 | wbrugge@partners.org |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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Effectiveness will be determined by change in stricture diameter (increase or decrease) after RFA procedure. This will be measure as percentage change in improvement of the stricture. |
| 2 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Feasibility: Ease of the Radiofrequency Ablation Catheter Placement | Determine the feasibility of radiofrequency ablation catheter placement across malignant strictures with using a subjective scale, 0 is being impossible to place the catheter and 10 is being very easy to place the catheter. | Posted | Number | units on a scale | 2 years |
|
|
|
| Secondary | Effectiveness: Change From Baseline in Bile Duct Diameter. | Effectiveness will be determined by change in stricture diameter (increase or decrease) after RFA procedure. This will be measure as percentage change in improvement of the stricture. | Posted | Number | percentage of improvement: | 2 years |
|
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|
| 0 |
| 1 |
| 0 |
| 1 |
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| D004066 |
| Digestive System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D013514 |
| Surgical Procedures, Operative |