Pancreatic Cancer, Unresectable Biliary-pancreatic Malignancies
Conditions
Keywords
Stent Placement, Biliary Obstruction, 14-260
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.
Interventions
DEVICEERCP with SEMS plus radiofrequency ablation
DEVICEERCP with SEMS alone (standard of care)
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Failure | 180 days |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Stent Patency | 1 and 3 months post procedure |
| Incidence of Procedure Related Complications | 1 month |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
ERCP with SEMS plus radiofrequency ablation | 13 |
| 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.
ERCP with SEMS alone (standard of care) | 11 |
| Total | 24 |
Baseline characteristics
| Characteristic | ERCP With SEMS Plus Radiofrequency Ablation | Total | ERCP With SEMS Alone (Standard of Care) |
|---|---|---|---|
| Age, Continuous | 62.5 years | 60.4 years | 57.9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 24 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 11 Participants | 20 Participants | 9 Participants |
| Region of Enrollment United States | 13 Participants | 24 Participants | 11 Participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 13 | 11 / 11 |
| other Total, other adverse events | 13 / 13 | 11 / 11 |
| serious Total, serious adverse events | 4 / 13 | 4 / 11 |
Outcome results
Primary
Rate of Failure
Time frame: 180 days
Population: Data were not collected
Secondary
Incidence of Procedure Related Complications
Time frame: 1 month
Population: Data were not collected
Secondary
Rate of Stent Patency
Time frame: 1 and 3 months post procedure
Population: Data were not collected