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The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| U-SEMS group | Active Comparator | Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific). |
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| C-SEMS Group | Active Comparator | Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covered Self-expanding metal biliary stents (C-SEMS) | Device | Used for palliation of inoperable malignant distal bile duct obstruction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Long-term Stent Failure | Compare the rate of long-term stent failure, defined as need for repeat biliary intervention (endoscopic, percutaneous, or surgical) following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Adverse Stent-related or Intervention-related Outcomes | Participants will be monitored for adverse stent-related or intervention-related outcomes such as pancreatitis, cholangitis, cholecystitis, perforation. | One Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Yachimski, MD, MPH | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | United States | ||
| Vanderbilt University Medical Center |
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4 participants screen failed before being randomized to either arm of the study. Only 6 participants was randomized (3 to each arm) and completed the study.
Participants were recruited from patient population at the Vanderbilt Digestive Disease Center. Between November 8, 2017 until June 14, 2019, only 6 participants were randomized and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | U-SEMS Group | Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific). Uncovered Self-expanding metal biliary stents (U-SEMS): Used for palliation of inoperable malignant distal bile duct obstructions. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2019 |
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| Uncovered Self-expanding metal biliary stents (U-SEMS) | Device | Used for palliation of inoperable malignant distal bile duct obstructions. |
|
| Nashville |
| Tennessee |
| 37212 |
| United States |
| C-SEMS Group |
Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific) Covered Self-expanding metal biliary stents (C-SEMS): Used for palliation of inoperable malignant distal bile duct obstruction. |
| COMPLETED |
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| NOT COMPLETED |
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3 participants were enrolled to each arm for a total of 6 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | U-SEMS Group | Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific). Uncovered Self-expanding metal biliary stents (U-SEMS): Used for palliation of inoperable malignant distal bile duct obstructions. |
| BG001 | C-SEMS Group | Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific) Covered Self-expanding metal biliary stents (C-SEMS): Used for palliation of inoperable malignant distal bile duct obstruction. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Rate of Long-term Stent Failure | Compare the rate of long-term stent failure, defined as need for repeat biliary intervention (endoscopic, percutaneous, or surgical) following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction. | 3 participants randomized to each arm for a total of 6 participants. Of the 3 participants in the U-SEMS group, none needed repeat intervention. Of the 3 participants in the C-SEMS group, 2 needed repeat intervention. | Posted | Count of Participants | Participants | One year |
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| Secondary | Rates of Adverse Stent-related or Intervention-related Outcomes | Participants will be monitored for adverse stent-related or intervention-related outcomes such as pancreatitis, cholangitis, cholecystitis, perforation. | 3 participants randomized to each arm for a total of 6 participants. Of the 3 participants in the U-SEMS group, there were no reports of pancreatitis, cholangitis, cholecystitis, or perforation. Of the 3 participants in the C-SEMS group, there were no reports of pancreatitis, cholangitis, cholecystitis, or perforation. | Posted | Count of Participants | Participants | One Year |
|
374 days
Definition of adverse event and/or serious adverse event did not differ from the clinicaltrials.gov definitions. All-Cause Mortality - 5 of the 6 participants were followed until their death. Deaths were not related to the study.
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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 | U-SEMS Group | Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific). Uncovered Self-expanding metal biliary stents (U-SEMS): Used for palliation of inoperable malignant distal bile duct obstructions. | 3 | 3 | 0 | 3 | 0 | 3 |
| EG001 | C-SEMS Group | Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific) Covered Self-expanding metal biliary stents (C-SEMS): Used for palliation of inoperable malignant distal bile duct obstruction. | 2 | 3 | 0 | 3 | 0 | 3 |
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Only 6 participants were randomized. A sample size of 96 patients (48 per treatment arm) would be required to detect a 20% difference in stent failure rates at 80% power with an alpha level of 0.05. As 6 participants falls very short of our required sample size, originally planned analysis was not completed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharee Burkeen, Research Program Manager | Vanderbilt University Medical Center | (615) 875-7515 | sharee.k.burkeen@vumc.org |
| Nov 29, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D018281 | Cholangiocarcinoma |
| D009369 | Neoplasms |
| D007565 | Jaundice |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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