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Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218242
Recruitment Status : Terminated (Unable to enroll enough participants)
First Posted : August 18, 2014
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Joel Thompson, PhD, University of Kentucky

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Intervention Device: Intraoperative ultrasound
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ultrasound
Hide Arm/Group Description

Intraoperative ultrasound

Intraoperative ultrasound: Intraoperative ultrasound

Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title Ultrasound
Hide Arm/Group Description

Intraoperative ultrasound

Intraoperative ultrasound: Intraoperative ultrasound

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  33.3%
>=65 years
6
  66.7%
[1]
Measure Description: Age information was collected at the time of consenting
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
4
  44.4%
Male
5
  55.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
9
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Detection of Occult Pathologic N2 Lymph Nodes
Hide Description 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.
Time Frame At time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Ultrasound
Hide Arm/Group Description:

Intraoperative ultrasound

Intraoperative ultrasound: Intraoperative ultrasound

Overall Number of Participants Analyzed 9
Overall Number of Units Analyzed
Type of Units Analyzed: Lymph nodes
20
Measure Type: Number
Unit of Measure: percentage of pathologic lymph nodes
0.0
Time Frame Adverse events were collected in the operating room at the time of the procedure. Typically less that 30 minutes.
Adverse Event Reporting Description Patients were assessed for adverse events through investigator assessment at the time of the procedure
 
Arm/Group Title Ultrasound
Hide Arm/Group Description

Intraoperative ultrasound

Intraoperative ultrasound: Intraoperative ultrasound

All-Cause Mortality
Ultrasound
Affected / at Risk (%)
Total   0/9 (0.00%) 
Hide Serious Adverse Events
Ultrasound
Affected / at Risk (%)
Total   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ultrasound
Affected / at Risk (%)
Total   0/9 (0.00%) 
The University of Kentucky Medical Center did not treat a sufficient patient population to enroll and complete this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Angela Mahan
Organization: University of Kentucky
Phone: 859 257 4488
EMail: angela.mahan@uky.edu
Layout table for additonal information
Responsible Party: Joel Thompson, PhD, University of Kentucky
ClinicalTrials.gov Identifier: NCT02218242    
Other Study ID Numbers: 13-LUN-95-MCC
First Submitted: August 13, 2014
First Posted: August 18, 2014
Results First Submitted: June 28, 2018
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018