| ID | Type | Description | Link |
|---|---|---|---|
| R21DK090708 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| American Society for Gastrointestinal Endoscopy | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open. This approach necessitates multiple procedures which may extend over one year before the stricture is adequately dilated. The investigators propose a study comparing the standard approach of plastic stenting with the use of newer, fully coated metallic stents which are self-expandable, thereby permitting successful dilation of benign bile duct strictures with fewer procedures.
Randomization, as detailed below, is stratified by etiology of the stricture: chronic pancreatitis and postoperative (such as post-liver transplant).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fully Covered Metallic Stent | Experimental | Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist. |
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| Plastic Stent | Active Comparator | Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fully covered Metallic Stent | Device | Covered Wallflex Biliary (TM) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Early Clinical Success | Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group. | Post-stent removal (up to one year after enrollment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory A Cote, MD, MS | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | United States | |||
| Indiana University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27002446 | Result | Cote GA, Slivka A, Tarnasky P, Mullady DK, Elmunzer BJ, Elta G, Fogel E, Lehman G, McHenry L, Romagnuolo J, Menon S, Siddiqui UD, Watkins J, Lynch S, Denski C, Xu H, Sherman S. Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1250-7. doi: 10.1001/jama.2016.2619. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fully Covered Metallic Stent | Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist. Fully covered Metallic Stent: Covered Wallflex Biliary (TM) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Plastic Stent |
| Device |
Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing ERCPs, until the stricture has been obliterated using clinical and fluoroscopic criteria. |
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| Indianapolis |
| Indiana |
| 46202 |
| United States |
| University of Michigan | Ann Arbor | Michigan | United States |
| Washington University in St. Louis | St Louis | Missouri | 63108 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Digestive Health Associates of Texas | Dallas | Texas | United States |
| Royal Wolverhampton NHS Trust | Wolverhampton | United Kingdom |
| FG001 | Plastic Stent | Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below). Plastic Stent: Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fully Covered Metallic Stent | Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist. Fully covered Metallic Stent: Covered Wallflex Biliary (TM) |
| BG001 | Plastic Stent | Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria. |
| 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 |
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| 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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| 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 | Early Clinical Success | Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group. | The number of participants analyzed is lower than the number of patients randomized, due to patients who dropped out of the study before all stents were removed. | Posted | Count of Participants | Participants | Post-stent removal (up to one year after enrollment) |
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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 | Fully Covered Metallic Stent | Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist. Fully covered Metallic Stent: Covered Wallflex Biliary (TM) | 14 | 57 | 8 | 57 | ||
| EG001 | Plastic Stent | Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria. | 9 | 55 | 8 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stent migration | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Cote | Medical University of South Carolin | 843-876-4261 | cotea@musc.edu |
| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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