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

Phase 3

Completed

Interventions: Device: ERCP with SEMS alone (standard of care)
Device: ERCP with SEMS plus radiofrequency ablation

Brief 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.

Recruitment & Eligibility

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 <7g/dL, thrombocytopenia <50K/mcL, or coagulopathy with INR >2.0)
Have biliary strictures not technically amenable to endoscopic therapy

Arm && Interventions

Group	Intervention	Description
ERCP with SEMS alone (standard of care)	ERCP with SEMS alone (standard of care)	Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period.
ERCP with SEMS plus radiofrequency ablation	ERCP with SEMS plus radiofrequency ablation	Endoscopic retrograde cholangiopancreatogram (ERCP) is performed under standard conditions with cannulation of the bile duct, and demonstration on a cholangiogram the location, diameter and length of the biliary stricture. The HabibTM EndoHBP probe (EMcision, London, United Kingdom) is advanced through the working channel of a side viewing endoscope over a 0.035in guidewire, and positioned across the occluded SEMS under fluoroscopy. 7-10W are usually delivered for 90 seconds with a standard high frequency generator, followed by a 1 minute resting period. Sequential applications of RFA are applied along the entire length of the stricture with an overlap of 1cm.

Primary Outcome Measures

Name	Time	Method
Rate of Failure	180 days

Secondary Outcome Measures

Name	Time	Method
Rate of Stent Patency	1 and 3 months post procedure
Incidence of Procedure Related Complications	1 month

Locations (1): Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States

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