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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct causing pain, jaundice (yellow skin and eyes), itchy skin and fever.
This is a prospective randomized trial conducted at 4 large teaching hospitals (Brigham and Women's Hospital, Massachusetts General Hospital, and Boston Medical Center, Boston, Massachusetts, and Mayo Clinic, Rochester, Minnesota).
Malignancy is determined by pathology. Cancer stage is determined by transabdominal imaging and/or endoscopic ultrasound (EUS). Written informed consent is obtained from each of the enrolled patients. The study is approved by the Institutional Review Boards at each of the participating centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uncovered Wallstent | Active Comparator | Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type). |
|
| Partially Covered Wallstent | Experimental | Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partially Covered Wallstent | Device | Partially covered wallstent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Recurrent Biliary Obstruction | Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death. | Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival | Patient survival is defined as the date of the placement of the stent to the date of death. Participants lost to follow-up were analyzed in an intention-to-treat fashion and censored at the time of their last follow-up interview. | Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L Carr-Locke, MD, FRCP | Brigham and Women's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21034891 | Result | Telford JJ, Carr-Locke DL, Baron TH, Poneros JM, Bounds BC, Kelsey PB, Schapiro RH, Huang CS, Lichtenstein DR, Jacobson BC, Saltzman JR, Thompson CC, Forcione DG, Gostout CJ, Brugge WR. A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc. 2010 Nov;72(5):907-14. doi: 10.1016/j.gie.2010.08.021. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Uncovered Wallstent | Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type). |
| FG001 | Partially Covered Wallstent | Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Uncovered Wallstent | Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type). |
| BG001 | Partially Covered Wallstent | Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time to Recurrent Biliary Obstruction | Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death. | All randomized participants. | Posted | Median | Inter-Quartile Range | days | Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm |
|
From time of stent placement to participant death or lost to follow-up (up to 1302 days).
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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 | Uncovered Wallstent | Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent biliary obstruction | Hepatobiliary disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David L. Carr-Locke, MD, FRCP | Brigham and Women's Hospital | dcarrlocke@chpnet.org |
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| Uncovered Wallstent |
| Device |
Uncovered wallstent |
|
| Number of Participants With Serious Adverse Events (SAEs) | Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death. | From time of stent placement to participant death or lost to follow-up (up to 1302 days) |
| Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism | Mechanisms of recurrent biliary obstructions are defined as tumor ingrowth, tumor overgrowth, stent migration, sludge, food debris, stent failed to expand and unknown. Stents may be obstructed by more than one mechanism, therefore, the total does not add up to the number of stent obstructions in each group. | Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm |
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
| OG001 | Partially Covered Wallstent | Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type). |
|
|
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| Secondary | Patient Survival | Patient survival is defined as the date of the placement of the stent to the date of death. Participants lost to follow-up were analyzed in an intention-to-treat fashion and censored at the time of their last follow-up interview. | All randomized participants. | Posted | Median | Inter-Quartile Range | days | Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm |
|
|
|
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) | Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death. | All randomized participants. | Posted | Count of Participants | Participants | From time of stent placement to participant death or lost to follow-up (up to 1302 days) |
|
|
|
| Secondary | Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism | Mechanisms of recurrent biliary obstructions are defined as tumor ingrowth, tumor overgrowth, stent migration, sludge, food debris, stent failed to expand and unknown. Stents may be obstructed by more than one mechanism, therefore, the total does not add up to the number of stent obstructions in each group. | All randomized participants. | Posted | Number | participants | Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm |
|
|
|
| 27 |
| 61 |
| 0 |
| 61 |
| EG001 | Partially Covered Wallstent | Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type). | 42 | 68 | 0 | 68 |
| Stent migration | General disorders |
|
| Pancreatitis | Gastrointestinal disorders |
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| Cholecystitis | Hepatobiliary disorders |
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| Pain | General disorders |
|
| Line infection | Infections and infestations |
|
| Nausea | Gastrointestinal disorders |
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| Dehydration | Metabolism and nutrition disorders |
|
| Deep vein thrombosis | Vascular disorders |
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| Gastric outlet obstruction | Gastrointestinal disorders |
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| Radiation gastritis | Gastrointestinal disorders |
|
| Pneumonia | Infections and infestations |
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| Stroke | Nervous system disorders |
|
| Whipple resection | Surgical and medical procedures |
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| Gastrointestinal bleeding | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Perforation | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Small bowel obstruction | Gastrointestinal disorders |
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| Hernia | Gastrointestinal disorders |
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| Liver abscess | Hepatobiliary disorders |
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| Cholangitis without biliary obstruction | Hepatobiliary disorders |
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| Cellulitis | Infections and infestations |
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| Fever | Infections and infestations |
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| Seizure | Nervous system disorders |
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| Change in mental status | Nervous system disorders |
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| Spinal surgery for cervical stenosis | Surgical and medical procedures |
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| Pulmonary embolus | Vascular disorders |
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| Myocardial infarction | Cardiac disorders |
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| Pulmonary edema | Respiratory, thoracic and mediastinal disorders |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders |
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| Urinary obstruction | Renal and urinary disorders |
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| Kidney stone | Renal and urinary disorders |
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| Epistaxis | Vascular disorders |
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| Stent migration |
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| Sludge |
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| Food debris in the stent |
|
| Stent failed to expand |
|
| Unknown |
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