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

Study Overview

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

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.

N/A

Pancreatic Cancer
Unresectable Biliary-pancreatic Malignancies

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

14-260

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-01-08	Results First Submitted 2020-09-28	Last Update Submitted that met QC Criteria 2020-09-28
First Submitted that Met QC Criteria 2015-01-13	Results First Submitted that Met QC Criteria 2020-09-28	Last Update Posted (ACTUAL) 2020-10-22
First Posted (ACTUAL) 2015-01-19	Results First Posted 2020-10-22	Last Verified 2019-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 (EMcis	DEVICE: ERCP with SEMS plus radiofrequency ablation
ACTIVE_COMPARATOR: 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 (EMcis	DEVICE: ERCP with SEMS alone (standard of care)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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 (EMcis

DEVICE: ERCP with SEMS plus radiofrequency ablation

ACTIVE_COMPARATOR: ERCP with SEMS alone (standard of care)

DEVICE: ERCP with SEMS alone (standard of care)

Primary Outcome Measures	Measure Description	Time Frame
Rate of Failure		180 days

Secondary Outcome Measures	Measure Description	Time Frame
Rate of Stent Patency		1 and 3 months post procedure
Incidence of Procedure Related Complications		1 month

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Mark Schattner, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record