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

Tracking Information
First Submitted Date ICMJE	December 23, 2009
First Posted Date ICMJE	December 24, 2009
Results First Submitted Date	June 9, 2016
Results First Posted Date	June 22, 2016
Last Update Posted Date	June 23, 2016
Study Start Date ICMJE	December 2009
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 9, 2016)	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
Original Primary Outcome Measures ICMJE; (submitted: December 23, 2009)	Assess the occlusion rates of plastic, covered, and uncovered biliary stents in patients presenting with malignant biliary obstruction. [ Time Frame: Time of stent occlusion or patient death ]
Change History	Complete list of historical versions of study NCT01038713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 9, 2016)	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 ]; 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; 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; Assess Rate of Acute Cholecystitis Associated With Each Type of Stent [ Time Frame: time from stent placement to 500 days ]
Original Secondary Outcome Measures ICMJE; (submitted: December 23, 2009)	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: Stent occlusion or patient death ]; Determine the rate of hospitalization following stent placement [ Time Frame: Time of stent occlusion or patient death ]; Assess days off of chemotherapy due to complications associated with the stents [ Time Frame: Time to stent occlusion or patient death ]; Assess Rate of Acute Cholecystitis Associated With Each Type of Stent [ Time Frame: Time to stent occlusion or patient death ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction
Official Title ICMJE	A Prospective Randomized Trial of Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction
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.
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Pancreatic Cancer
Intervention ICMJE	Device: Biliary stent placement; Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Study Arms	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. Intervention: Device: Biliary stent placement; 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. Intervention: Device: Biliary stent placement; 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. Intervention: Device: Biliary stent placement; 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. Intervention: Device: Biliary stent placement; 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. Intervention: Device: Biliary stent placement
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 7, 2014)	94
Original Estimated Enrollment ICMJE; (submitted: December 23, 2009)	100
Actual Study Completion Date	December 2013
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Male or female older than 18; Capable of providing written informed consent; 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; Inability to undergo conscious sedation or monitored anesthesia; Prior pancreatico-biliary surgery; Evidence of acute cholecystitis at time of endoscopic procedure; Intraluminal filling defect requiring endoscopic removal prior to stent placement; Inability to provide written informed consent; Malignancy not verified prior to stent placement
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01038713
Other Study ID Numbers ICMJE	2009-01
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dartmouth-Hitchcock Medical Center
Study Sponsor ICMJE	Dartmouth-Hitchcock Medical Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Timothy Gardner, M.D. Dartmouth-Hitchcock Medical Center
PRS Account	Dartmouth-Hitchcock Medical Center
Verification Date	June 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP