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| Name | Class |
|---|---|
| University of Rochester | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
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Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies for obtaining diagnostic tissue from biliary strictures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric Biopsy Forceps directed biopsies | Experimental | Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained. |
|
| Cholangioscopy-directed biopsies | Active Comparator | Biopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsies of bile duct stricture with pediatric biopsy forceps | Procedure | Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen | Malignancy or no malignancy diagnosis obtained from stricture biopsy | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Cost | Cumulative $ from devices used and facility fees with each approach | 2 years |
| Radiation Exposure | Total Dose, Fluoroscopy Time, Dose Area Product, Effective dose per fluoroscopy machine readings |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States |
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Randomized prospective study
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| Biopsies of bile duct stricture with cholangioscopy-directed biopsies | Procedure | Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies |
|
| 2 years |
| Procedure Duration | in minutes | 2 years |
| Latency to diagnosis | Duration in days from initial procedure to diagnosis of benign or malignant stricture | 2 years |
| Adverse Events | (Pancreatitis, Bleeding, Infection, Perforation, Death to be assessed one day, one week post-procedure | 2 weeks |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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