N/A
N=119
Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02238847 ↗Enrolled (actual)
119
Serious AEs
21.9%
Results posted
Feb 2020
Primary outcome: Primary: Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms — 39; 43 Participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- WallFlex™ Biliary RX Fully Covered/Uncovered Stent System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms |
39; 43 | <0.01 sig |
| SECONDARY Procedure-related or Stent-related Serious Adverse Events |
14; 12 | 0.66 |
| SECONDARY Technical Success |
58; 60 | — |
| SECONDARY Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention |
53; 51 | — |
| SECONDARY Number of Participants With Stent Migration |
5; 0 | — |
| SECONDARY Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure |
3; 4 | — |
| SECONDARY For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement |
19; 21 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02238847). 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.