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

18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Assess the occlusion rates of plastic, covered, and uncovered biliary stents in patients presenting with malignant biliary obstruction.

Outcome Time Frame:

Time of stent occlusion or patient death

Safety Issue:


Principal Investigator

Timothy Gardner, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2009

Completion Date:

December 2013

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms



Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756