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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340728
• Other study ID #: 14-260
• Status: Completed
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: November 2019

Study information

• Verified date: December 2019
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Neoplasms
• Pancreatic Cancer
• Unresectable Biliary-pancreatic Malignancies

Intervention

Device:
• ERCP with SEMS plus radiofrequency ablation

• ERCP with SEMS alone (standard of care)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Failure		180 days
Secondary	Rate of Stent Patency		1 and 3 months post procedure
Secondary	Incidence of Procedure Related Complications		1 month

External Links

•   Memorial Sloan Kettering Cancer Center