Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction
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ClinicalTrials.gov Identifier: NCT01038713 |
Recruitment Status
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Completed
First Posted
: December 24, 2009
Results First Posted
: June 22, 2016
Last Update Posted
: June 23, 2016
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Sponsor:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
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Tracking Information | ||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
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 |
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Original Secondary Outcome Measures ICMJE |
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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 |
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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. |
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Study Arms |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
94 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria
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Sex/Gender |
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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 |
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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 |