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

NCT02340728 | Completed Phase 3 Results

• 1 other identifier: 14-260
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Stent Placement; Biliary Obstruction; 14-260

Outcome Measures

Primary Outcomes (1)

• Rate of Failure

  180 days

Secondary Outcomes (2)

• Rate of Stent Patency

  1 and 3 months post procedure

• Incidence of Procedure Related Complications

  1 month

Study Arms (2)

ERCP with SEMS plus radiofrequency ablation

EXPERIMENTAL

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.

Device: ERCP with SEMS plus radiofrequency ablation

ERCP with SEMS alone (standard of care)

ACTIVE COMPARATOR

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.

Device: ERCP with SEMS alone (standard of care)

Interventions

ERCP with SEMS plus radiofrequency ablation DEVICE

Also known as: self expandable metal stents, co-axial stent placement

ERCP with SEMS plus radiofrequency ablation

ERCP with SEMS alone (standard of care) DEVICE

Also known as: self expandable metal stents, co-axial stent placement

ERCP with SEMS alone (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cholangiopancreatography, Endoscopic Retrograde; Radiofrequency Ablation; Self Expandable Metallic Stents

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Stents; Prostheses and Implants; Equipment and Supplies

Results Point of Contact

• Title: Mark Schattner, MD
• Organization: Memorial Sloan Kettering Cancer Center

schattnm@mskcc.org

212-639-3148

Study Officials

• Mark Schattner, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 19, 2015
• Study Start: January 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2019-12

Locations

US (1)