Phase 3
Completed N=24
Endoscopic Biliary Co-axial Stent Placement Plus/Minus Use of Radiofrequency Ablation (RFA) for Clearance of Occluded Self Expandable Metal Stents (SEMS) in Patients With Distal Biliary Obstruction From Unresectable Biliary-pancreatic Malignancies
Source: ClinicalTrials.gov NCT02340728 ↗Enrolled (actual)
24
Serious AEs
33.3%
Results posted
Oct 2020
Primary outcomePrimary: Rate of Failure
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to compare the effects good and/or bad of combining radiofrequency ablation with placement of a second stent, versus a second stent alone. The investigators will also look at the safety of the combination treatment, and see which treatment is better. In either case, the second stent will be placed inside the existing stent as is done in standard practice when treating a blocked stent for the first time.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Failure |
— | — |
| SECONDARY Rate of Stent Patency |
— | — |
| SECONDARY Incidence of Procedure Related Complications |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients with any tumor obstructing the distal bile duct and causing an indwelling biliary SEMS
- Patients with jaundice or clinical cholangitis, with new elevation of alkaline phosphatase, total bilirubin, and imaging findings supportive of stent occlusion (loss of stent patency, debris within stent, loss of or excessive pneumobilia)
- Age ≥ 18 years
Exclusion Criteria
- Have altered gastro-duodenal or hepatobiliary anatomy such that ERCP is felt to be unacceptably technically difficult or unsafe
- Have additional sites of biliary strictures (intrahepatic/hilar) such that ERCP stenting is felt to be unlikely to provide adequate clinical benefit
- Have cardiac pacemakers
- Have Child B/C cirrhosis
- Are pregnant
- Are unsuitable for endoscopy (either because of hemodynamic instability, respiratory distress or unsafe hematological parameters such as refractory anemia 2.0)
- Have biliary strictures not technically amenable to endoscopic therapy
Data sourced from ClinicalTrials.gov (NCT02340728). 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. Informational only — not medical advice.