Trial Outcomes & Findings for Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer (NCT NCT01303159)

NCT ID: NCT01303159

Last Updated: 2017-05-23

Results Overview

To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2017-05-23

Participant Flow

Participant milestones

Measure	Radiofrequency Probe (ENDOHPB) Intervention: The EndoHPB Radiofrequency probe
Overall Study STARTED	29
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Measure	Radiofrequency Probe (ENDOHPB) Intervention: The EndoHPB Radiofrequency probe
Overall Study Death	16
Overall Study Study Termination	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Radiofrequency Probe (ENDOHPB) n=29 Participants Intervention: The EndoHPB Radiofrequency probe
Age, Continuous	69 years STANDARD_DEVIATION 12.9 • n=29 Participants
Sex: Female, Male Female	7 Participants n=29 Participants
Sex: Female, Male Male	22 Participants n=29 Participants
Region of Enrollment United States	29 Participants n=29 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Participants not analyzed has study was terminated before follow up data could be collected.

To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer

Outcome measures

Measure	Radiofrequency Probe (ENDOHPB) Intervention: The EndoHPB Radiofrequency probe
Change From Baseline in Bile Duct Stricture Diameter	0

SECONDARY outcome

Timeframe: 2 years

Population: Preliminary analyses because study was terminated before follow up data could be collected.

To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer

Outcome measures

Measure	Radiofrequency Probe (ENDOHPB) n=29 Participants Intervention: The EndoHPB Radiofrequency probe
Number of Participants With Adverse Events	16 participants

Adverse Events

Radiofrequency Probe (ENDOHPB)

Serious events: 16 serious events

Other events: 0 other events

Deaths: 16 deaths

Serious adverse events

Measure	Radiofrequency Probe (ENDOHPB) n=29 participants at risk Intervention: The EndoHPB Radiofrequency probe
Gastrointestinal disorders Fever	13.8% 4/29 • Number of events 4 • 6 months
Gastrointestinal disorders Death	55.2% 16/29 • Number of events 16 • 6 months
Gastrointestinal disorders Gastrointestinal Bleeding	3.4% 1/29 • Number of events 1 • 6 months
Gastrointestinal disorders Cholecystitis	3.4% 1/29 • Number of events 1 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Michel Kahaleh

Weill Cornell Medical College

Phone: 646-962-4797

Email: mik9071@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place