CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 24 enrolled
Drug / intervention
ERCP with SEMS plus radiofrequency ablation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02340728
NCT02340728Phase 3Completed

A Randomized Trial of 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

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 19, 2015·Updated Oct 22, 2020

In Brief

A Phase 3 clinical trial evaluating ERCP with SEMS plus radiofrequency ablation and ERCP with SEMS alone (standard of care) for Pancreatic Cancer and Unresectable Biliary-pancreatic Malignancies. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 19, 2015
Enrollment StartJan 1, 2015
Primary CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.5 years ago

Interventions

ERCP with SEMS plus radiofrequency ablationdevice

ERCP with SEMS alone (standard of care)device