Phase 3 N=24 Randomized Treatment

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

Pancreatic Cancer · Unresectable Biliary-pancreatic Malignancies

Bottom Line

View on ClinicalTrials.gov: NCT02340728 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Oct 2020

Primary outcome: Primary: Rate of Failure

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ERCP with SEMS plus radiofrequency ablation (Device); ERCP with SEMS alone (standard of care) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Failure	—	—
SECONDARY Rate of Stent Patency	—	—
SECONDARY Incidence of Procedure Related Complications	—	—

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.

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

View full record on ClinicalTrials.gov →

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.