Trial Outcomes & Findings for Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound (NCT NCT02218242)

Last Updated: 2018-11-07

Results Overview

Participants undergoing resection of lung tumors will have laparoscopic thoracic wall ultrasound in an attempt to identify pathologic N2 lymph nodes. Data will be presented as the ratio of lymph nodes identified as cancerous to the total number of lymph nodes investigated with the ultrasound technique.

Recruitment status

TERMINATED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

At time of surgery

Results posted on

2018-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Ultrasound Intraoperative ultrasound Intraoperative ultrasound: Intraoperative ultrasound
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasound n=9 Participants Intraoperative ultrasound Intraoperative ultrasound: Intraoperative ultrasound
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants
Sex: Female, Male Female	4 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	9 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	9 participants n=93 Participants

PRIMARY outcome

Timeframe: At time of surgery

Population: An insufficient number of participants were consented to generate meaningful data for this study. We reached an enrollment of less than 10% of what our power calculations suggested we needed. No pathologic lymph nodes were identified, thus the percent of pathologic lymph nodes is in fact zero

Outcome measures

Outcome measures
Measure	Ultrasound n=20 lymph nodes Intraoperative ultrasound Intraoperative ultrasound: Intraoperative ultrasound
Detection of Occult Pathologic N2 Lymph Nodes	0.0 percentage of pathologic lymph nodes

Adverse Events

Ultrasound

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

Angela Mahan

University of Kentucky

Phone: 859 257 4488

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place