Pancreatic Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBiliary stent placement
Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female older than 18 2. Capable of providing written informed consent 3. Presenting with malignant biliary obstruction requiring biliary drainage either from proximal pancreatic malignancy, metastatic disease, or intrinsic biliary malignancy. The patient must have an established diagnosis of underlying malignancy, and surgical resectability status established, prior to enrollment in this study.
Exclusion criteria
1. Inability to undergo conscious sedation or monitored anesthesia 2. Prior pancreatico-biliary surgery 3. Evidence of acute cholecystitis at time of endoscopic procedure 4. Intraluminal filling defect requiring endoscopic removal prior to stent placement 5. Inability to provide written informed consent 6. Malignancy not verified prior to stent placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Time of stent occlusion, attempted surgical resection or patient death to 300 days | Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From stent placement up to 500 days post stent | Number of total days of hospitalization for all patients in each group |
| Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents | Time from stent placement to 500 days | Total number of days in which neoadjuvant therapy was delayed due to stent related issues |
| Assess Rate of Acute Cholecystitis Associated With Each Type of Stent | time from stent placement to 500 days | — |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
94 patients recruited for the study. 63 were randomized into three arms
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 17 |
| 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. | 16 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Autoimmune Pancreatitis | 1 | 0 | 0 |
| Overall Study | died from PEP | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 0 | 0 |
| Overall Study | Neuroendocrine Tumor | 0 | 1 | 0 |
| Overall Study | Patient to hospice | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Resectable; Plastic Stent | Resectable; Uncovered Metal Stent | Resectable; Fully Covered Metal Stent | Total |
|---|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 9.67 | 64.8 years STANDARD_DEVIATION 8.47 | 67.2 years STANDARD_DEVIATION 11.4 | 65.9 years STANDARD_DEVIATION 9.74 |
| Region of Enrollment United States | 21 participants | 17 participants | 16 participants | 54 participants |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 7 Participants | 23 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 9 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 3 / 17 | 3 / 16 |
| serious Total, serious adverse events | 0 / 21 | 0 / 17 | 0 / 16 |
Outcome results
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
Time frame: Time of stent occlusion, attempted surgical resection or patient death to 300 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Resectable; Plastic Stent | Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Death | 6 participants |
| Resectable; Plastic Stent | Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Attempted Surgical Resection | 4 participants |
| Resectable; Plastic Stent | Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Stent Occlusion | 11 participants |
| Resectable; Uncovered Metal Stent | Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Attempted Surgical Resection | 6 participants |
| Resectable; Uncovered Metal Stent | Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Stent Occlusion | 6 participants |
| Resectable; Uncovered Metal Stent | Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Death | 5 participants |
| Resectable; Fully Covered Metal Stent | Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Stent Occlusion | 4 participants |
| Resectable; Fully Covered Metal Stent | Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Death | 4 participants |
| Resectable; Fully Covered Metal Stent | Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. | Attempted Surgical Resection | 8 participants |
p-value: 0.22Chi-squared
Comparison: Analysis comparing the rate of attempted surgical resectionp-value: 0.14Chi-squared
Comparison: Analysis comparing the rate of death between groupsp-value: 0.96Chi-squared
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
Time frame: Time from stent placement to 500 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resectable; Plastic Stent | Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents | 73 Days |
| Resectable; Uncovered Metal Stent | Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents | 50 Days |
| Resectable; Fully Covered Metal Stent | Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents | 3 Days |
Secondary
Assess Rate of Acute Cholecystitis Associated With Each Type of Stent
Time frame: time from stent placement to 500 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resectable; Plastic Stent | Assess Rate of Acute Cholecystitis Associated With Each Type of Stent | 0 Participants |
| Resectable; Uncovered Metal Stent | Assess Rate of Acute Cholecystitis Associated With Each Type of Stent | 0 Participants |
| Resectable; Fully Covered Metal Stent | Assess Rate of Acute Cholecystitis Associated With Each Type of Stent | 0 Participants |
Secondary
Determine the Days of Hospitalization Following Stent Placement
Number of total days of hospitalization for all patients in each group
Time frame: From stent placement up to 500 days post stent
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resectable; Plastic Stent | Determine the Days of Hospitalization Following Stent Placement | 0 Days |
| Resectable; Uncovered Metal Stent | Determine the Days of Hospitalization Following Stent Placement | 14 Days |
| Resectable; Fully Covered Metal Stent | Determine the Days of Hospitalization Following Stent Placement | 15 Days |
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.
Time frame: Costs measured up to 500 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resectable; Plastic Stent | Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement. | 39,955 United States Dollars |
| Resectable; Uncovered Metal Stent | Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement. | 41,476 United States Dollars |
| Resectable; Fully Covered Metal Stent | Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement. | 41,112 United States Dollars |
p-value: 1ANOVA