Trial Outcomes & Findings for CrYobiopsy With Radial UltraSound Guidance (NCT NCT03506295)

Last Updated: 2019-11-12

Results Overview

This is defined as time from when the bronchoscope and cryoprobe are removed en bloc after obtaining the cryobiopsy to the time when it is determined to be safe to proceed to next cryobiopsy("Ready for next biopsy").

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

From time of randomization up to 120 minutes.

Results posted on

2019-11-12

Participant Flow

Each patient underwent TBC, and 4 samples of cryobiopsies were obtained per patient. 2 biopsies were obtained with Standard of Care procedures and 2 biopsies used the radial ultrasound probe will be used in addition to standard of care. All participants received both interventions.

Unit of analysis: cryobiopsies

Participant milestones

Participant milestones
Measure	All Participants Each participant received 4 Transbronchial cryobiopsies during a single procedure: 2 cryobiopsies are obtained as a standard of care under fluoroscopy guidance. The other 2 biopsies are obtained using a radial probe ultrasound under fluoroscopy guidance. All participants received both inventions during the same procedure. Fluoroscopy: Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement. fluoroscopy: Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement.
Overall Study STARTED	10 40
Overall Study COMPLETED	10 40
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CrYobiopsy With Radial UltraSound Guidance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=10 Participants Participants scheduled for cryobiopsy as part of their for routine clinical care had 4 biopsies: 2 with Transbronchial cryobiopsies as a standard of care and 2 with radial probe ultrasound. All participants received both interventions. Standard of Care - Transbronchial cryobiopsies are obtained as a standard of care under fluoroscopy guidance Fluoroscopy: Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants
Age, Continuous	61.5 years STANDARD_DEVIATION 9.789450104 • n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants

PRIMARY outcome

Timeframe: From time of randomization up to 120 minutes.

Population: All participants received both interventions during the same procedure.

Outcome measures

Outcome measures
Measure	Control n=20 biopsies Standard of Care - Transbronchial cryobiopsies are obtained as a standard of care under Fluoroscopy guidance fluoroscopy: Real-time Fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement.	Intervention n=20 biopsies In the intervention arm , radial ultrasound probe will be used in addition to standard of care described above to confirm adequate position of the cryoprobe before transbronchial cryobiopsy is obtained. Radial Endobronchial Ultrasound Probe: The radial EBUS procedure is performed by inserting a miniature ultrasound probe (radial EBUS probe) through the working channel of a flexible bronchoscope or catheter (guide sheath). Real-time imaging of the surrounding tissue enables the clinician to determine the lesion's exact location and size. Fluoroscopy: Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement.
Time to Achieve Hemostasis After Obtaining Cryobiopsy	146.55 seconds Interval 7.0 to 614.0	132.25 seconds Interval 23.0 to 920.0

SECONDARY outcome

Timeframe: From time of randomization up to 120 minutes.

Population: All participants received both interventions during the same procedure.

0)No or only scant bleeding, stops spontaneously 1. Mild, stops with suction or iced saline or scope tamponade 2. Modest, stops with balloon blockade \< 3 min 3. Moderate,requires bleeding side down in addition to balloon 4. Severe, requires prolonged blockade (\> 3 min) 5. Very severe,soils opposite lung, hypoxemia, increase level of care, additional procedures All participants received both interventions during the same procedure.

Outcome measures

Outcome measures
Measure	Control n=20 cryobiopsies Standard of Care - Transbronchial cryobiopsies are obtained as a standard of care under Fluoroscopy guidance fluoroscopy: Real-time Fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement.	Intervention n=20 cryobiopsies In the intervention arm , radial ultrasound probe will be used in addition to standard of care described above to confirm adequate position of the cryoprobe before transbronchial cryobiopsy is obtained. Radial Endobronchial Ultrasound Probe: The radial EBUS procedure is performed by inserting a miniature ultrasound probe (radial EBUS probe) through the working channel of a flexible bronchoscope or catheter (guide sheath). Real-time imaging of the surrounding tissue enables the clinician to determine the lesion's exact location and size. Fluoroscopy: Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement.
Grade of Bleeding 3)Moderate,requires bleeding side down in addition	0 cryobiopsies	0 cryobiopsies
Grade of Bleeding 0)No or only scant bleeding, stops spontaneously	9 cryobiopsies	12 cryobiopsies
Grade of Bleeding 1)Mild, stops with suction or iced saline or scope	8 cryobiopsies	7 cryobiopsies
Grade of Bleeding 2) Modest, stops with balloon blockade < 3 min	2 cryobiopsies	1 cryobiopsies
Grade of Bleeding 4) Severe, requires prolonged blockade (> 3 min)	1 cryobiopsies	0 cryobiopsies
Grade of Bleeding 5)Very severe,soils opposite lung, hypoxemia, incr	0 cryobiopsies	0 cryobiopsies

SECONDARY outcome

Timeframe: From time of randomization up to 120 minutes.

Population: All participants received both interventions during the same procedure.

Cold saline, patient positioning, rigid bronchoscopy, embolization, ICU admission etc. are techniques to control bleeding after cryobiopsy. Use of these techniques will be recorded.

Outcome measures

Outcome measures
Measure	Control n=20 cryobiopsies Standard of Care - Transbronchial cryobiopsies are obtained as a standard of care under Fluoroscopy guidance fluoroscopy: Real-time Fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement.	Intervention n=20 cryobiopsies In the intervention arm , radial ultrasound probe will be used in addition to standard of care described above to confirm adequate position of the cryoprobe before transbronchial cryobiopsy is obtained. Radial Endobronchial Ultrasound Probe: The radial EBUS procedure is performed by inserting a miniature ultrasound probe (radial EBUS probe) through the working channel of a flexible bronchoscope or catheter (guide sheath). Real-time imaging of the surrounding tissue enables the clinician to determine the lesion's exact location and size. Fluoroscopy: Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement.
Number of Biopsies That Required Additional Interventions to Manage Bleeding	6 biopsies	5 biopsies

SECONDARY outcome

Timeframe: From time of randomization until acquisition of results from pathology, assessed up to 12 months.

Population: this analysis was removed from the protocol and data were not collected

Each biopsy obtained will be assessed by pathologist for quality of sample obtained and injury patterns identified

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From time of randomization until acquisition of results from pathology, assessed up to 12 months.

Population: this analysis was removed from the protocol and data were not collected

Each biopsy obtained will be assessed by pathologist for size of sample obtained.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

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

Dr. Fabien Maldonado

Vanderbilt University Medical Center

Phone: 615-322-3412

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place