Clinical trial · Interventional
Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction
A Prospective Randomized Trial of Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biliary stent placement | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Resectable; plastic stent
- description
- Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.
- interventionNames
- Device: Biliary stent placement
- type
- EXPERIMENTAL
- label
- Resectable; uncovered metal stent
- description
- 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.
- interventionNames
- Device: Biliary stent placement
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGardner 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. PMID 26972022