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

NCT ID: NCT02340728

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-11-30

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.

Conditions

Pancreatic Cancer; Unresectable Biliary-pancreatic Malignancies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ERCP with SEMS plus radiofrequency ablation

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

ERCP with SEMS alone (standard of care)

Intervention Type: DEVICE

Interventions

ERCP with SEMS plus radiofrequency ablation

Intervention Type: DEVICE

ERCP with SEMS alone (standard of care)

Intervention Type: DEVICE

Other Intervention Names

self expandable metal stents; co-axial stent placement; self expandable metal stents; co-axial stent placement

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Schattner, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

14-260

Identifier Type: -

Identifier Source: org_study_id