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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01038713
First received: December 23, 2009
Last updated: June 21, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention
Pancreatic Cancer
Device: Biliary stent placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. [ Time Frame: Time of stent occlusion, attempted surgical resection or patient death to 300 days ] [ Designated as safety issue: Yes ]
    Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Determine the Days of Hospitalization Following Stent Placement [ Time Frame: From stent placement up to 500 days post stent ] [ Designated as safety issue: No ]
    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 Frame: Time from stent placement to 500 days ] [ Designated as safety issue: Yes ]
    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 Frame: time from stent placement to 500 days ] [ Designated as safety issue: Yes ]

Enrollment: 94
Study Start Date: December 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Biliary stent placement
Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Experimental: 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.
Device: Biliary stent placement
Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Experimental: 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.
Device: Biliary stent placement
Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Experimental: Unresectable; uncovered metal stent
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.
Device: Biliary stent placement
Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Experimental: Unresectable; fully covered metal stent
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.
Device: Biliary stent placement
Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038713

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Timothy Gardner, M.D. Dartmouth-Hitchcock Medical Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01038713     History of Changes
Other Study ID Numbers: 2009-01 
Study First Received: December 23, 2009
Results First Received: June 9, 2016
Last Updated: June 21, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 23, 2016