Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

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, participants. Stent Occlusion: Resectable; Plastic Stent (n=21): 11; Resectable; Uncovered Metal Stent (n=17): 6; Resectable; Fully Covered Metal Stent (n=16): 4. Attempted Surgical Resection: Resectable; Plastic Stent (n=21): 4; Resectable; Uncovered Metal Stent (n=17): 6; Resectable; Fully Covered Metal Stent (n=16): 8. Death: Resectable; Plastic Stent (n=21): 6; Resectable; Uncovered Metal Stent (n=17): 5; Resectable; Fully Covered Metal Stent (n=16): 4. Analysis, Resectable; Plastic Stent vs Resectable; Uncovered Metal Stent vs Resectable; Fully Covered Metal Stent: p=0.22; Chi-squared; superiority or other. Analysis, Resectable; Plastic Stent vs Resectable; Uncovered Metal Stent vs Resectable; Fully Covered Metal Stent: p=0.14; Chi-squared; superiority or other. Analysis, Resectable; Plastic Stent vs Resectable; Uncovered Metal Stent vs Resectable; Fully Covered Metal Stent: p=0.96; Chi-squared; superiority or other.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

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]. Number, United States Dollars. Resectable; Plastic Stent (n=21): 39,955; Resectable; Uncovered Metal Stent (n=17): 41,476; Resectable; Fully Covered Metal Stent (n=16): 41,112. Analysis, Resectable; Plastic Stent vs Resectable; Uncovered Metal Stent vs Resectable; Fully Covered Metal Stent: p=1.00; ANOVA; superiority or other.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Determine the Days of Hospitalization Following Stent Placement [From stent placement up to 500 days post stent]. Number, Days. Resectable; Plastic Stent (n=21): 0; Resectable; Uncovered Metal Stent (n=17): 14; Resectable; Fully Covered Metal Stent (n=16): 15.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents [Time from stent placement to 500 days]. Number, Days. Resectable; Plastic Stent (n=21): 73; Resectable; Uncovered Metal Stent (n=17): 50; Resectable; Fully Covered Metal Stent (n=16): 3.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Assess Rate of Acute Cholecystitis Associated With Each Type of Stent [time from stent placement to 500 days]. Number, Participants. Resectable; Plastic Stent (n=21): 0; Resectable; Uncovered Metal Stent (n=17): 0; Resectable; Fully Covered Metal Stent (n=16): 0.