N/A
N=63
Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01038713 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. — 11; 6; 4; 4 participants — p=0.22
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biliary stent placement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. |
11; 6; 4; 4; 6; 8 | 0.22 |
| SECONDARY Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement. |
39,955; 41,476; 41,112 | 1.00 |
| SECONDARY Determine the Days of Hospitalization Following Stent Placement |
0; 14; 15 | — |
| SECONDARY Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents |
73; 50; 3 | — |
| SECONDARY Assess Rate of Acute Cholecystitis Associated With Each Type of Stent |
0; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01038713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.