Malignant Neoplasms of Respiratory and Intrathoracic OrgansNCT03523689
Radial-Probe Endobronchial Ultrasound in Detecting Atelectasis in Patients Undergoing Peripheral Bronchoscopy
An observational study of Malignant Neoplasms of Respiratory and Intrathoracic Organs and Lung Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well radial-probe endobronchial ultrasound works in detecting the complete or partial collapse of the lung in patients undergoing peripheral bronchoscopy. Diagnostic procedures, such as radial-probe endobronchial ultrasound and bronchoscopy, use a thin, tube-like instrument inserted through the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms of Respiratory and Intrathoracic Organs, Lung Neoplasm
- What is being tested?
- Bronchoscopy and Radial Probe Endobronchial Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2018to 26 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing bronchoscopy with radial EBUS for peripheral lung lesions
Who may be able to join
- Patients undergoing bronchoscopy with radial EBUS for peripheral lung lesions
- Recent computed tomography (CT) performed no more than 4 weeks prior to the bronchoscopy
- Voluntary informed consent to participate in the study
Who cannot join
- Patients with baseline lung consolidation, interstitial changes or lung masses (> 3 cm in diameter) in dependent areas of the lung as seen on most recent CT
- Pregnancy
- Ascites
- Known diaphragmatic paralysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Location of Intra-Procedural Atelectasis Detected by Radial-Probe Endobronchial Ultrasound During Peripheral Bronchoscopy Under General Anesthesia
This trial studies how well radial-probe endobronchial ultrasound works in detecting the complete or partial collapse of the lung in patients undergoing peripheral bronchoscopy. Diagnostic procedures, such as radial-probe endobronchial ultrasound and bronchoscopy, use a thin, tube-like instrument inserted through the nose or mouth to view and take pictures of the inside of the trachea, air passages, and lungs.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the proportion of patients identified as developing intraprocedural atelectasis detected by radial-probe endobronchial ultrasound (RP-EBUS) during peripheral bronchoscopy under general anesthesia.
SECONDARY OBJECTIVES:
- To describe the most common locations for developing intraprocedural atelectasis detected by RP-EBUS.
II. To describe the proportion of evaluated bronchial segments per patient that are identified as developing intraprocedural atelectasis by RP-EBUS.
III. To identify patient and procedural characteristics that may predispose to the development of atelectasis.
OUTLINE:
Patients undergo bronchoscopy per standard of care, RP-EBUS of the left and right lungs during bronchoscopy procedure, and RP-imaging over 3-5 minutes at the end of the bronchoscopy procedure.
- Being tested
- Bronchoscopy, Radial Probe Endobronchial Ultrasound
- Keywords
- Malignant neoplasms of respiratory and intrathoracic organs, Endobronchial ultrasound-guided transbronchial needle aspiration, EBUS-TBNA
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
Undergo bronchoscopy
Radial Probe Endobronchial UltrasoundProcedure or surgery
Also called Radial EBUS, Radial Endobronchial Ultrasound, Radial Probe EBUS, Radial-Probe Endobronchial Ultrasound
Undergo RP-EBUS
| Study group | Role | What they receive |
|---|---|---|
| Observational (bronchoscopy, RP-EBUS) | Patients undergo bronchoscopy per standard of care, RP-EBUS of the left and right lungs during bronchoscopy procedure, and RP-imaging over 3-5 minutes at the end of the bronchoscopy procedure. Receives: Procedure: Bronchoscopy; Procedure: Radial Probe Endobronchial Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
New atelectasis for each segment
Presence or absence of atelectasis within each of the aforementioned 8 segments will be determined using radial-probe endobronchial ultrasound (RP-EBUS) in comparison with the most recent computed tomography (CT) performed < 4 weeks prior to the bronchoscopy. A segment will be identified as having a new atelectasis if there is an indication of solid- or semisolid-appearing lesion by RP-EBUS without a corresponding indication of solid tumor or atelectasis on the preoperative CT. Descriptive statistics (frequencies, proportions, means, standard deviations, and ranges) will be provided for patient characteristics. The proportion of patients identified as developing intraprocedural atelectasis by RP-EBUS and its 95% confidence interval will be estimated to accomplish the primary objective.
Measured: Up to 3 years
Atelectasis for each patient
Patients with at least 1 segment containing a new atelectasis will be determined to have atelectasis. Patients without atelectasis within any of the 8 segments will be determined to not have atelectasis. The proportion of patients identified as developing intraprocedural atelectasis by RP-EUS and its 95% confidence interval will be estimated to accomplish the primary objective.
Measured: Up to 3 years
Secondary outcomes (3)
Common locations exhibiting atelectasis
Locations of atelectasis will be summarized by a frequency table, allowing for multiple locations in the same patient.
Measured: Up to 3 years
Proportion of evaluated bronchial segments developing intraprocedural atelectasis
The proportion of segments identified as developing atelectasis among all evaluated segments will be calculated for each patient, and the distribution of the proportion will be summarized by the mean, median, and range. We will compare patients with atelectasis and patients without atelectasis in terms of patient characteristics using a t-test or Wilcoxon test for continuous variables and Fisher's exact test or chi-squared test for categorical variables.
Measured: Up to 3 years
Patient characteristics associated with the presence of atelectasis
To identify patient characteristics associated with the presence of atelectasis, logistic regression analysis will be used if the number of patients with atelectasis is at least 10. Due to a small sample size, multivariate logistic regression analysis may not be applied. A p-value of less than 0.05 will indicate statistical significance.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start30 Apr 2018
- Primary completion26 Oct 2020
- Study completion26 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasms of Respiratory and Intrathoracic OrgansStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roberto F Casal, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523689
- Sponsor's protocol ID
- 2018-0123
- Other IDs
- NCI-2018-00964, 2018-0123
- Status last verified
- Nov 2020
- First submitted
- 1 May 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sagar AS, Sabath BF, Eapen GA, Song J, Marcoux M, Sarkiss M, Arain MH, Grosu HB, Ost DE, Jimenez CA, Casal RF. Incidence and Location of Atelectasis Developed During Bronchoscopy Under General Anesthesia: The I-LOCATE Trial. Chest. 2020 Dec;158(6):2658-2666. doi: 10.1016/j.chest.2020.05.565. Epub 2020 Jun 17.
PubMed 32561439
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Location of Intra-Procedural Atelectasis Detected by Radial-Probe Endobronchial Ultrasound During Peripheral Bronchoscopy Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03523689
- Acronym / sponsor ID
- 2018-0123
- Keywords
- Malignant neoplasms of respiratory and intrathoracic organs, Endobronchial ultrasound-guided transbronchial needle aspiration, EBUS-TBNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies how well radial-probe endobronchial ultrasound works in detecting the complete or partial collapse of the lung in patients undergoing peripheral bronchoscopy. Diagnostic procedures, such as radial-probe endobronchial ultrasound and bronchoscopy, use a thin, tube-like instrument inserted through the nose or mouth to view and take pictures of the inside of the trachea, air passages, and lungs.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the proportion of patients identified as developing intraprocedural atelectasis detected by radial-probe endobronchial ultrasound (RP-EBUS) during peripheral bronchoscopy under general anesthesia.
SECONDARY OBJECTIVES:
- To describe the most common locations for developing intraprocedural atelectasis detected by RP-EBUS.
II. To describe the proportion of evaluated bronchial segments per patient that are identified as developing intraprocedural atelectasis by RP-EBUS.
III. To identify patient and procedural characteristics that may predispose to the development of atelectasis.
OUTLINE:
Patients undergo bronchoscopy per standard of care, RP-EBUS of the left and right lungs during bronchoscopy procedure, and RP-imaging over 3-5 minutes at the end of the bronchoscopy procedure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (bronchoscopy, RP-EBUS) | – | Procedure: Bronchoscopy, Procedure: Radial Probe Endobronchial UltrasoundPatients undergo bronchoscopy per standard of care, RP-EBUS of the left and right lungs during bronchoscopy procedure, and RP-imaging over 3-5 minutes at the end of the bronchoscopy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing bronchoscopy with radial EBUS for peripheral lung lesions
Key inclusion criteria (3 listed)
- Patients undergoing bronchoscopy with radial EBUS for peripheral lung lesions
- Recent computed tomography (CT) performed no more than 4 weeks prior to the bronchoscopy
- Voluntary informed consent to participate in the study
Key exclusion criteria (4 listed)
- Patients with baseline lung consolidation, interstitial changes or lung masses (> 3 cm in diameter) in dependent areas of the lung as seen on most recent CT
- Pregnancy
- Ascites
- Known diaphragmatic paralysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopyUndergo bronchoscopy | Procedure or surgery | Observational (bronchoscopy, RP-EBUS) |
| Radial Probe Endobronchial UltrasoundAlso: Radial EBUS, Radial Endobronchial Ultrasound, Radial Probe EBUS, Radial-Probe Endobronchial UltrasoundUndergo RP-EBUS | Procedure or surgery | Observational (bronchoscopy, RP-EBUS) |
Primary outcome
New atelectasis for each segment
Time frame: Up to 3 years
Presence or absence of atelectasis within each of the aforementioned 8 segments will be determined using radial-probe endobronchial ultrasound (RP-EBUS) in comparison with the most recent computed tomography (CT) performed < 4 weeks prior to the bronchoscopy. A segment will be identified as having a new atelectasis if there is an indication of solid- or semisolid-appearing lesion by RP-EBUS without a corresponding indication of solid tumor or atelectasis on the preoperative CT. Descriptive statistics (frequencies, proportions, means, standard deviations, and ranges) will be provided for patient characteristics. The proportion of patients identified as developing intraprocedural atelectasis by RP-EBUS and its 95% confidence interval will be estimated to accomplish the primary objective.
Atelectasis for each patient
Time frame: Up to 3 years
Patients with at least 1 segment containing a new atelectasis will be determined to have atelectasis. Patients without atelectasis within any of the 8 segments will be determined to not have atelectasis. The proportion of patients identified as developing intraprocedural atelectasis by RP-EUS and its 95% confidence interval will be estimated to accomplish the primary objective.
3 secondary outcomes
Common locations exhibiting atelectasis
Time frame: Up to 3 years
Proportion of evaluated bronchial segments developing intraprocedural atelectasis
Time frame: Up to 3 years
Patient characteristics associated with the presence of atelectasis
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 32561439Sagar AS, Sabath BF, Eapen GA, Song J, Marcoux M, Sarkiss M, Arain MH, Grosu HB, Ost DE, Jimenez CA, Casal RF. Incidence and Location of Atelectasis Developed During Bronchoscopy Under General Anesthesia: The I-LOCATE Trial. Chest. 2020 Dec;158(6):2658-2666. doi: 10.1016/j.chest.2020.05.565. Epub 2020 Jun 17.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Malignant Neoplasms of Respiratory and Intrathoracic Organs
RecruitingPhase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
Malignant Neoplasms of Respiratory and Intrathoracic Organs, Squamous Cell Carcinoma of the Larynx
RecruitingPhase 1
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
Malignant Neoplasm of Bone and Articular Cartilage, Malignant Neoplasms of Female Genital Organs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto F Casal principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasms of Respiratory and Intrathoracic Organs and Lung Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New atelectasis for each segment (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03523689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.