Clinical trial · Interventional
Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
Randomized Controlled Trial Comparing Covered and Uncovered Biliary Self Expanding Metal Stents (SEMS) for Pre-operative Drainage During Neoadjuvant Therapy in Patients With Pancreatic Cancer
NCT02238847CI-TRIAL-00043443completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.
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 |
|---|---|---|---|
| WallFlex™ Biliary RX Fully Covered/Uncovered Stent System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- WallFlex Biliary RX Fully Covered Stent System
- description
- Patients in this group will receive a fully covered study SEMS (self-expanding metal stent) Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
- interventionNames
- Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
- type
- ACTIVE_COMPARATOR
- label
- WallFlex Biliary RX Uncovered Stent System
- description
- Patients in this group will receive an uncovered study SEMS (self-expanding metal stent). Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
- interventionNames
- Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 or older * Patient indicated for biliary metal stent placement for the treatment of jaundice and/or cholestasis * Willing and able to comply with the study procedures and provide written informed consent to participate in the study * Suspicion of pancreatic adenocarcinoma * Likely indicated for neoadjuvant treatment * Distal biliary obstruction consistent with pancreatic cancer * Location of distal biliary obstruction such that it would allow the proximal end of a stent to be positioned at least 2 cm from the hilum * Endoscopic and surgical treatment to be provided at the same institution Exclusion Criteria: * Benign biliary strictures * Malignancy secondary to Intraductal Papillary Mucinous Neoplasm * Surgically altered anatomy where ERCP is not possible * Previous biliary drainage using a SEMS or multiple plastic stents * Contraindications for endoscopic techniques * Patients who are currently enrolled in another investigational trial that would directly interfere with the current study * Pregnancy
References
Publications (1)
- DERIVEDSeo DW, Sherman S, Dua KS, Slivka A, Roy A, Costamagna G, Deviere J, Peetermans J, Rousseau M, Nakai Y, Isayama H, Kozarek R; Biliary SEMS During Neoadjuvant Therapy Study Group. Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial. Gastrointest Endosc. 2019 Oct;90(4):602-612.e4. doi: 10.1016/j.gie.2019.06.032. Epub 2019 Jul 2. PMID 31276674