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The purpose of this study is to compare the effects good and/or bad of combining radiofrequency ablation with placement of a second stent, versus a second stent alone. The investigators will also look at the safety of the combination treatment, and see which treatment is better. In either case, the second stent will be placed inside the existing stent as is done in standard practice when treating a blocked stent for the first time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERCP with SEMS plus radiofrequency ablation | Experimental | Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. Sequential applications of RFA are applied along the entire length of the stricture with an overlap of 1cm. |
|
| ERCP with SEMS alone (standard of care) | Active Comparator | Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP with SEMS plus radiofrequency ablation | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Failure | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Stent Patency | 1 and 3 months post procedure | |
| Incidence of Procedure Related Complications | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Schattner, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ERCP With SEMS Plus Radiofrequency Ablation | Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. Sequential applications of RFA are applied along the entire length of the stricture with an overlap of 1cm. ERCP with SEMS plus radiofrequency ablation |
| 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 | Oct 3, 2016 |
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| ERCP with SEMS alone (standard of care) | Device |
|
|
| FG001 | ERCP With SEMS Alone (Standard of Care) | Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. ERCP with SEMS alone (standard of care) |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ERCP With SEMS Plus Radiofrequency Ablation | Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. Sequential applications of RFA are applied along the entire length of the stricture with an overlap of 1cm. ERCP with SEMS plus radiofrequency ablation |
| BG001 | ERCP With SEMS Alone (Standard of Care) | Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. ERCP with SEMS alone (standard of care) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Rate of Failure | Data were not collected | Posted | 180 days |
|
| |||||||||||||||||||||||
| Secondary | Rate of Stent Patency | Data were not collected | Posted | 1 and 3 months post procedure |
| ||||||||||||||||||||||||
| Secondary | Incidence of Procedure Related Complications | Data were not collected | Posted | 1 month |
|
Up to 180 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 | ERCP With SEMS Plus Radiofrequency Ablation | Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. Sequential applications of RFA are applied along the entire length of the stricture with an overlap of 1cm. ERCP with SEMS plus radiofrequency ablation | 12 | 13 | 4 | 13 | 13 | 13 |
| EG001 | ERCP With SEMS Alone (Standard of Care) | Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. ERCP with SEMS alone (standard of care) | 11 | 11 | 4 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
| ||
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| INR increased | Investigations | Systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypermagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Lipase increased | Investigations | Systematic Assessment |
| ||
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Serum amylase increased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
| ||
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Activated partial thromboplastin time prolonged | Investigations | Systematic Assessment |
| ||
| Fibrinogen decreased | Investigations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Schattner, MD | Memorial Sloan Kettering Cancer Center | 212-639-3148 | schattnm@mskcc.org |
| Sep 23, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| D000078703 | Radiofrequency Ablation |
| D000069322 | Self Expandable Metallic Stents |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|