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

Pancreatic Cancer Clinical Trial

Official title:

A Prospective Randomized Trial of Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038713
• Other study ID #: 2009-01
• Status: Completed
• Phase: N/A
• First received: December 23, 2009
• Last updated: June 21, 2016
• Start date: December 2009
• Est. completion date: December 2013

Study information

• Verified date: June 2016
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• Biliary stent placement
Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 of stent occlusion, attempted surgical resection or patient death to 300 days	Yes
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.		Costs measured up to 500 days	No
Secondary	Determine the Days of Hospitalization Following Stent Placement	Number of total days of hospitalization for all patients in each group	From stent placement up to 500 days post stent	No
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 from stent placement to 500 days	Yes
Secondary	Assess Rate of Acute Cholecystitis Associated With Each Type of Stent		time from stent placement to 500 days	Yes