Trial Outcomes & Findings for 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 NCT02340728)
NCT ID: NCT02340728
Last Updated: 2020-10-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
24 participants
Primary outcome timeframe
180 days
Results posted on
2020-10-22
Participant Flow
Participant milestones
| Measure |
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
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
ERCP With SEMS Plus Radiofrequency Ablation
n=13 Participants
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
|
ERCP With SEMS Alone (Standard of Care)
n=11 Participants
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)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
n=93 Participants
|
57.9 years
n=4 Participants
|
60.4 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 and 3 months post procedurePopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
ERCP With SEMS Plus Radiofrequency Ablation
Serious events: 4 serious events
Other events: 13 other events
Deaths: 12 deaths
ERCP With SEMS Alone (Standard of Care)
Serious events: 4 serious events
Other events: 11 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
ERCP With SEMS Plus Radiofrequency Ablation
n=13 participants at risk
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
|
ERCP With SEMS Alone (Standard of Care)
n=11 participants at risk
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)
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec
|
7.7%
1/13 • Up to 180 days
|
0.00%
0/11 • Up to 180 days
|
|
Gastrointestinal disorders
Colitis
|
7.7%
1/13 • Up to 180 days
|
0.00%
0/11 • Up to 180 days
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
7.7%
1/13 • Up to 180 days
|
0.00%
0/11 • Up to 180 days
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Up to 180 days
|
0.00%
0/11 • Up to 180 days
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/13 • Up to 180 days
|
9.1%
1/11 • Up to 180 days
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/13 • Up to 180 days
|
9.1%
1/11 • Up to 180 days
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/13 • Up to 180 days
|
9.1%
1/11 • Up to 180 days
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/13 • Up to 180 days
|
9.1%
1/11 • Up to 180 days
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/13 • Up to 180 days
|
9.1%
1/11 • Up to 180 days
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/13 • Up to 180 days
|
9.1%
1/11 • Up to 180 days
|
Other adverse events
| Measure |
ERCP With SEMS Plus Radiofrequency Ablation
n=13 participants at risk
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
|
ERCP With SEMS Alone (Standard of Care)
n=11 participants at risk
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)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
13/13 • Up to 180 days
|
100.0%
11/11 • Up to 180 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
76.9%
10/13 • Up to 180 days
|
63.6%
7/11 • Up to 180 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
23.1%
3/13 • Up to 180 days
|
18.2%
2/11 • Up to 180 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
13/13 • Up to 180 days
|
90.9%
10/11 • Up to 180 days
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
69.2%
9/13 • Up to 180 days
|
45.5%
5/11 • Up to 180 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
69.2%
9/13 • Up to 180 days
|
63.6%
7/11 • Up to 180 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
15.4%
2/13 • Up to 180 days
|
9.1%
1/11 • Up to 180 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
13/13 • Up to 180 days
|
100.0%
11/11 • Up to 180 days
|
|
Metabolism and nutrition disorders
Hypernatremia
|
30.8%
4/13 • Up to 180 days
|
27.3%
3/11 • Up to 180 days
|
|
Investigations
INR increased
|
92.3%
12/13 • Up to 180 days
|
81.8%
9/11 • Up to 180 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
53.8%
7/13 • Up to 180 days
|
72.7%
8/11 • Up to 180 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.7%
1/13 • Up to 180 days
|
9.1%
1/11 • Up to 180 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
13/13 • Up to 180 days
|
100.0%
11/11 • Up to 180 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
53.8%
7/13 • Up to 180 days
|
63.6%
7/11 • Up to 180 days
|
|
Investigations
Lipase increased
|
15.4%
2/13 • Up to 180 days
|
27.3%
3/11 • Up to 180 days
|
|
Investigations
Creatinine increased
|
38.5%
5/13 • Up to 180 days
|
9.1%
1/11 • Up to 180 days
|
|
Investigations
Serum amylase increased
|
23.1%
3/13 • Up to 180 days
|
9.1%
1/11 • Up to 180 days
|
|
Investigations
Platelet count decreased
|
84.6%
11/13 • Up to 180 days
|
63.6%
7/11 • Up to 180 days
|
|
Investigations
Blood bilirubin increased
|
76.9%
10/13 • Up to 180 days
|
100.0%
11/11 • Up to 180 days
|
|
Investigations
Lymphocyte count decreased
|
53.8%
7/13 • Up to 180 days
|
63.6%
7/11 • Up to 180 days
|
|
Investigations
Neutrophil count decreased
|
46.2%
6/13 • Up to 180 days
|
27.3%
3/11 • Up to 180 days
|
|
Investigations
White blood cell decreased
|
69.2%
9/13 • Up to 180 days
|
54.5%
6/11 • Up to 180 days
|
|
Investigations
Alkaline phosphatase increased
|
84.6%
11/13 • Up to 180 days
|
100.0%
11/11 • Up to 180 days
|
|
Investigations
Alanine aminotransferase increased
|
84.6%
11/13 • Up to 180 days
|
90.9%
10/11 • Up to 180 days
|
|
Investigations
Aspartate aminotransferase increased
|
92.3%
12/13 • Up to 180 days
|
100.0%
11/11 • Up to 180 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
69.2%
9/13 • Up to 180 days
|
45.5%
5/11 • Up to 180 days
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/13 • Up to 180 days
|
9.1%
1/11 • Up to 180 days
|
Additional Information
Mark Schattner, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3148
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place