Trial Outcomes & Findings for Endoscopic Therapy of Malignant Bile Duct Strictures (NCT NCT01543607)

Results Overview

Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

2 years

Results posted on

2017-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Endoscopic Therapy of Malignant Bile Duct Strictures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=1 Participants Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)

Outcome measures

Outcome measures
Measure	Treatment n=1 Participants Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct
Safety: Number of Bile Leak After RFA Procedure	1 bile leak

SECONDARY outcome

Timeframe: 2 years

Determine the feasibility of radiofrequency ablation catheter placement across malignant strictures with using a subjective scale, 0 is being impossible to place the catheter and 10 is being very easy to place the catheter.

Outcome measures

Outcome measures
Measure	Treatment n=1 Participants Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct
Feasibility: Ease of the Radiofrequency Ablation Catheter Placement	10 units on a scale

SECONDARY outcome

Timeframe: 2 years

Effectiveness will be determined by change in stricture diameter (increase or decrease) after RFA procedure. This will be measure as percentage change in improvement of the stricture.

Outcome measures

Outcome measures
Measure	Treatment n=1 Participants Radiofrequency ablation catheter Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct
Effectiveness: Change From Baseline in Bile Duct Diameter.	50 percentage of improvement:

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William R. Brugge

Mass. General Hospital

Phone: 617-724-0578

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place