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
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/6/2019 |
| Start Date: | January 2015 |
| End Date: | January 2020 |
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
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.
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.
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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 212-639-3148
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
