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This is a single center, randomized, unblinded study to compare the rate of occlusion of plastic, uncovered metal, or fully covered metal biliary stents in patient's with surgically resectable disease or those undergoing neoadjuvant chemoradiotherapy. We will also compare occlusion rates between uncovered metal and fully covered metal biliary stents in those patients determined to have surgically unresectable disease.
Malignant biliary obstruction can result from extrinsic processes, such as proximal pancreatic ductal adenocarcinoma or metastatic lesions, or from intrinsic lesions such as cholangiocarcinoma. Malignant biliary obstruction is typically treated endoscopically with placement of either plastic (polyethylene) or metal biliary stents. Metal stents have a wider diameter than plastic stents, and have been shown to have higher patency rates, but are also 15-40 times the cost of plastic stents. Metal stents with a polymer coating have been developed to prevent tumor ingrowth into the stent, which can lead to stent occlusion. Cost analysis has demonstrated an advantage to the use of metal stents in patients with unresectable disease, or who may achieve operable status following neoadjuvant chemotherapy, while either plastic stents or metal stents are used when patients are deemed to have a surgically resectable lesion. Patient's determined to have resectable, or borderline resectable malignancy (those who may achieve resectability status following neoadjuvant chemotherapy) will receive either plastic, uncovered metal, or covered metal stents in a randomized fashion, while patients determined to have surgically unresectable malignancy will randomly receive either covered or uncovered metal biliary stents. The primary aim of this study is to prospectively evaluate stent occlusion rates in patients presenting with malignant biliary obstruction. Secondary aims of the study will include a cost analysis of each stent type, rate of hospital admission following stent placement, days off of chemotherapy due to procedural complication, and rate of acute cholecystitis associated with stent placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resectable; plastic stent | Experimental | Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. |
|
| Resectable; uncovered metal stent | Experimental | Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. |
|
| Resectable; fully covered metal stent | Experimental | Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. |
|
| Unresectable; uncovered metal stent | Experimental | Patients determined to have surgically non-resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. |
|
| Unresectable; fully covered metal stent | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biliary stent placement | Device | Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement | Time of stent occlusion, attempted surgical resection or patient death to 300 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement. | Costs measured up to 500 days | |
| Determine the Days of Hospitalization Following Stent Placement | Number of total days of hospitalization for all patients in each group |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Gardner, M.D. | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26972022 | Derived | Gardner TB, Spangler CC, Byanova KL, Ripple GH, Rockacy MJ, Levenick JM, Smith KD, Colacchio TA, Barth RJ, Zaki BI, Tsapakos MJ, Gordon SR. Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial. Gastrointest Endosc. 2016 Sep;84(3):460-6. doi: 10.1016/j.gie.2016.02.047. Epub 2016 Mar 10. |
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94 patients recruited for the study. 63 were randomized into three arms
The protocol initially was designed to measure five groups - we elected not to study patients with unresectable disease and thus only patients with presumed resectable disease are included
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| ID | Title | Description |
|---|---|---|
| FG000 | Resectable; Plastic Stent | Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP. |
| FG001 | Resectable; Uncovered Metal Stent | Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP. |
| FG002 | Resectable; Fully Covered Metal Stent | Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Resectable; Plastic Stent | Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP. |
| 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 | Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement | Posted | Number | participants | Time of stent occlusion, attempted surgical resection or patient death to 300 days |
|
Time from stent placement to 500 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 | Resectable; Plastic Stent | Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-ERCP Pancreatitis | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Gardner | Dartmouth-Hitchcock Medical Center | 603-650-6472 | timothy.b.gardner@hitchcock.org |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Patients determined to have surgically non-resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. |
|
| From stent placement up to 500 days post stent |
| Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents | Total number of days in which neoadjuvant therapy was delayed due to stent related issues | Time from stent placement to 500 days |
| Assess Rate of Acute Cholecystitis Associated With Each Type of Stent | time from stent placement to 500 days |
| Neuroendocrine Tumor |
|
| died from PEP |
|
| Autoimmune Pancreatitis |
|
| BG001 |
| Resectable; Uncovered Metal Stent |
Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP. |
| BG002 | Resectable; Fully Covered Metal Stent | Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP. |
| OG002 | Resectable; Fully Covered Metal Stent | Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP. |
|
|
|
| Secondary | Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement. | Posted | Number | United States Dollars | Costs measured up to 500 days |
|
|
|
|
| Secondary | Determine the Days of Hospitalization Following Stent Placement | Number of total days of hospitalization for all patients in each group | Posted | Number | Days | From stent placement up to 500 days post stent |
|
|
|
| Secondary | Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents | Total number of days in which neoadjuvant therapy was delayed due to stent related issues | Posted | Number | Days | Time from stent placement to 500 days |
|
|
|
| Secondary | Assess Rate of Acute Cholecystitis Associated With Each Type of Stent | Posted | Number | Participants | time from stent placement to 500 days |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Resectable; Uncovered Metal Stent | Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP. | 0 | 17 | 3 | 17 |
| EG002 | Resectable; Fully Covered Metal Stent | Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP. | 0 | 16 | 3 | 16 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |