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

• ClinicalTrials.gov Identifier: NCT01038713
• Recruitment Status: Completed
• First Posted: December 24, 2009
• Results First Posted: June 22, 2016
• Last Update Posted: June 23, 2016
• Sponsor: Dartmouth-Hitchcock Medical Center
• Information provided by (Responsible Party): Dartmouth-Hitchcock Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pancreatic Cancer	Device: Biliary stent placement	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: December 2009
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement

Secondary Outcome Measures :

1. 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 ]
2. Determine the Days of Hospitalization Following Stent Placement [ Time Frame: From stent placement up to 500 days post stent ]
   Number of total days of hospitalization for all patients in each group
3. Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents [ Time Frame: Time from stent placement to 500 days ]
   Total number of days in which neoadjuvant therapy was delayed due to stent related issues
4. Assess Rate of Acute Cholecystitis Associated With Each Type of Stent [ Time Frame: time from stent placement to 500 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gardner TB, Spangler CC, Byanova KL, Ripple GH, Rockacy MJ, Levenick JM, Smith KD, Colacchio TA, Barth RJ, Zaki BI, Tsapakos MJ, Gordon SR. Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial. Gastrointest Endosc. 2016 Sep;84(3):460-6. doi: 10.1016/j.gie.2016.02.047. Epub 2016 Mar 10.

• Responsible Party: Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT01038713
• Other Study ID Numbers: 2009-01
• First Posted: December 24, 2009
• Results First Posted: June 22, 2016
• Last Update Posted: June 23, 2016
• Last Verified: June 2016