Event of Undetermined Intent (Y21-Y33)NCT05385419
Diagnostic Value of Bronchoscopic and Thoracoscopic Frozen Section Biopsies in Patients With Pleuropulmonary Tumors
A study testing Bronchoscopic and thoracoscopic frozen section biopsies in people with Event of Undetermined Intent (Y21-Y33), run by Assiut University.
Trial summary
Lung cancer is the second most commonly diagnosed cancer worldwide, after breast cancer, and its incidence continues to grow. Flexible bronchoscopy is the diagnostic tool of choice to diagnose endobronchial malignancies. It allows inspection and biopsy of any endobronchial abnormalities under direct vision. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Event of Undetermined Intent (Y21-Y33)
- What is being tested?
- Bronchoscopic and thoracoscopic frozen section biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2022to 30 Dec 2023
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presented with suspected lung neoplastic lesion indicated for bronchoscopy -
- Patients presented with undiagnosed pleural effusion (suspected malignant pleural effusion) who are candidate for thoracoscopy
Who cannot join
- Age <18 years old.
- Contraindications for bronchoscopy:
- Uncorrectable hypoxemia
- Unstable angina
- Uncontrolled arrhythmias
- Unexplained or severe hypercarbia
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- Uncontrolled asthma
- Uncorrectable coagulopathy
- Contraindications for thoracoscopy:
- Transudative pleural effusion
About this study
Lung cancer is the second most commonly diagnosed cancer worldwide, after breast cancer, and its incidence continues to grow. Flexible bronchoscopy is the diagnostic tool of choice to diagnose endobronchial malignancies. It allows inspection and biopsy of any endobronchial abnormalities under direct vision. Despite specimens are obtained under direct vision, there is a significant failure rate. This may necessitate repeating bronchoscopy. To guide the bronchoscopist on the quality and quantity of specimens during bronchoscopic biopsies for the diagnosis of lung cancer is rapid on-site evaluation (ROSE) of cytological specimens. Intra-procedural Frozen Section Evaluation (FROSE) of bronchoscopic biopsy specimens is an alternative to ROSE and helps preventing repeated bronchoscopies. Medical thoracoscopy increases the diagnostic yield of MPE as it offers the clinician a "window" for direct visualization and collection of samples from the parietal pleura.The acquracy of frozen section biopsies in pleural tumours is largely undefined. Confirmation of the pleural malignancy can lead to immediate pleurodesis following the pleural inspection and biopsy. To our knowledge limited studies discussed the value of frozen section in both bronchoscopic and thoracoscopic biopsies.
Read the detailed description
All included patients will be subjected to the following:
- Full medical history and clinical examination.
- Routine investigation: complete blood count, liver function test, kidney function test, coagulation profile and arterial blood gases.
- Imaging:
- Chest X-ray.
- Chest Ultrasound to evaluate the amount of pleural effusion and the presence of adhesions.
- MSCT Chest with contrast.
- Pleural fluid study including serum pleural albumin gradient (SPAG), Pleural fluid PH and pleural fluid cytology.
Flexible Bronchoscopy (PENTAX, EB-1970TK 3.2) will be done after instillation of lidocaine 2% by spray and procedural sedation with midazolam (0.01-0.1mg\kg) with continuous monitoring for O2 saturation, heart rate, blood preesure and respiratory rate throughout the procedure. The bronchoscope will be introduced into the nasal cavity and advanced to the level of the vocal cords. Lidocaine 2% will be instilled through the bronchoscope to the vocal cords and tracheobronchial tree to minimize cough. Assessment of the appearance and movement of the cords will be done. As the bronchoscope is advanced beyond the vocal cords, careful inspection of the entire airway will be done. Biopsies from abnormal endobronchial lesions or mucosal abnormalities will be performed. Any evidence of narrowing or dynamic collapse, will be assessed. The biopsies will be sent for both frozen section and permenant paraffin section. Once sufficient tissue sample is confirmed the procedure will be terminated. Final assessment of the airway will be performed to ensure adequate hemostasis.
Medical thoracoscopy using (Karl Storz Heine optical 6mm, Tübingen Germany) with single-port-of-entry technique will be performed under local anesthesia and conscious sedation using midazolam (0.01-0.1mg\kg) or mepredine (0.9mg\kg). The point of entery will be guided with chest ultrasonography. Vertical incision will be made with the scalpel (usually near the midaxillary line), through the skin and subcutaneous tissue, appropriate to the size of the used trocar, usually of approximately 10 mm, parallel with and in the middle of the selected intercostal space. Then the trocar will be inserted in a corkscrew motion until the sudden release of resistance (after passing the costal pleura) is felt, while holding the handle of the trocar firmly in the palm of the hand, as index finger is extended. Under direct vision with the thoracoscope, introduction of pneumothorax will be performed and all pleural fluid will be removed and the pleural cavity will be inspected. Suspicious areas (irregularities, nodules, hyperemic lesions) will be biopsied through the working channel of the thoracoscope using the forceps biopsy.The biopsies will be sent for both frozen section and permenant paraffin section. Intraprocedual confirmation of malignancy will be followed immediately with pleurodesis. An intercostal drain will be placed with underwater seal drainage to drain residual air and fluid from the pleural cavity, allowing the lung to re -expand. The indications for removal of chest tubes will be absence of air leakage and cessation of fluid flow (100-150 mL daily).
The specimen prepared for frozen section will be placed on a metal tissue disc which is then secured in a chuck and frozen rapidly to about -20 to -30 °C. The specimen will be embedded in a gel like medium called optimal cutting temperature compound (OCT) and consisting of polyethylene glycol and polyvinyl alcohol. Subsequently it will be cut frozen with the microtome portion of the cryostat, the section will be picked up on a glass slide and stained (usually with hematoxylin and eosin, the H\&E stain).
- Conditions
- Event of Undetermined Intent (Y21-Y33)
- Being tested
- Bronchoscopic and thoracoscopic frozen section biopsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic and thoracoscopic frozen section biopsiesDiagnostic test
Flexible bronchoscopy for patients with lung endobronchial lesion, the bronchoscopic biopsy will be sent for frozen section and permenant paraffin section Medical thoracoscopy for patients with undiagnosed pleural effusion, the thoracoscopic biopsy will be sent for both frozen section and permenant paraffin section
| Study group | Role | What they receive |
|---|---|---|
| Patients subjected for bronchoscopy or medical thoracoscopy | Other | Bronchoscopic and thoracoscopic biopsies will be sent for both frozen section and permenant paraffin section Receives: Diagnostic Test: Bronchoscopic and thoracoscopic frozen section biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
determining the spceficity and sensitivity of bronhcoscopic and thoracoscopic frozen section biopsy
The accuracy of bronchoscopic and thoracoscopic frozen section to be malignant or non malignant or suspicious
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start15 Jun 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
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 Event of Undetermined Intent (Y21-Y33)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Badwy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385419
- Sponsor's protocol ID
- 457
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fielding D, Hopkins P, Serisier D. Frozen section of pleural biopsies at medical thoracoscopy assists in correctly identifying benign disease. Respirology. 2005 Nov;10(5):636-42. doi: 10.1111/j.1440-1843.2005.00761.x.
PubMed 16268918
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Bronchoscopic and Thoracoscopic Frozen Section Biopsies in Patients With Pleuropulmonary Tumors
- ClinicalTrials.gov ID
- NCT05385419
- Acronym / sponsor ID
- 457
- Conditions
- Event of Undetermined Intent (Y21-Y33)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 May 2022 (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.
Lung cancer is the second most commonly diagnosed cancer worldwide, after breast cancer, and its incidence continues to grow. Flexible bronchoscopy is the diagnostic tool of choice to diagnose endobronchial malignancies. It allows inspection and biopsy of any endobronchial abnormalities under direct vision. Despite specimens are obtained under direct vision, there is a significant failure rate. This may necessitate repeating bronchoscopy. To guide the bronchoscopist on the quality and quantity of specimens during bronchoscopic biopsies for the diagnosis of lung cancer is rapid on-site evaluation (ROSE) of cytological specimens. Intra-procedural Frozen Section Evaluation (FROSE) of bronchoscopic biopsy specimens is an alternative to ROSE and helps preventing repeated bronchoscopies. Medical thoracoscopy increases the diagnostic yield of MPE as it offers the clinician a "window" for direct visualization and collection of samples from the parietal pleura.The acquracy of frozen section biopsies in pleural tumours is largely undefined. Confirmation of the pleural malignancy can lead to immediate pleurodesis following the pleural inspection and biopsy. To our knowledge limited studies discussed the value of frozen section in both bronchoscopic and thoracoscopic biopsies.
Detailed description
All included patients will be subjected to the following:
- Full medical history and clinical examination.
- Routine investigation: complete blood count, liver function test, kidney function test, coagulation profile and arterial blood gases.
- Imaging:
- Chest X-ray.
- Chest Ultrasound to evaluate the amount of pleural effusion and the presence of adhesions.
- MSCT Chest with contrast.
- Pleural fluid study including serum pleural albumin gradient (SPAG), Pleural fluid PH and pleural fluid cytology.
Flexible Bronchoscopy (PENTAX, EB-1970TK 3.2) will be done after instillation of lidocaine 2% by spray and procedural sedation with midazolam (0.01-0.1mg\kg) with continuous monitoring for O2 saturation, heart rate, blood preesure and respiratory rate throughout the procedure. The bronchoscope will be introduced into the nasal cavity and advanced to the level of the vocal cords. Lidocaine 2% will be instilled through the bronchoscope to the vocal cords and tracheobronchial tree to minimize cough. Assessment of the appearance and movement of the cords will be done. As the bronchoscope is advanced beyond the vocal cords, careful inspection of the entire airway will be done. Biopsies from abnormal endobronchial lesions or mucosal abnormalities will be performed. Any evidence of narrowing or dynamic collapse, will be assessed. The biopsies will be sent for both frozen section and permenant paraffin section. Once sufficient tissue sample is confirmed the procedure will be terminated. Final assessment of the airway will be performed to ensure adequate hemostasis.
Medical thoracoscopy using (Karl Storz Heine optical 6mm, Tübingen Germany) with single-port-of-entry technique will be performed under local anesthesia and conscious sedation using midazolam (0.01-0.1mg\kg) or mepredine (0.9mg\kg). The point of entery will be guided with chest ultrasonography. Vertical incision will be made with the scalpel (usually near the midaxillary line), through the skin and subcutaneous tissue, appropriate to the size of the used trocar, usually of approximately 10 mm, parallel with and in the middle of the selected intercostal space. Then the trocar will be inserted in a corkscrew motion until the sudden release of resistance (after passing the costal pleura) is felt, while holding the handle of the trocar firmly in the palm of the hand, as index finger is extended. Under direct vision with the thoracoscope, introduction of pneumothorax will be performed and all pleural fluid will be removed and the pleural cavity will be inspected. Suspicious areas (irregularities, nodules, hyperemic lesions) will be biopsied through the working channel of the thoracoscope using the forceps biopsy.The biopsies will be sent for both frozen section and permenant paraffin section. Intraprocedual confirmation of malignancy will be followed immediately with pleurodesis. An intercostal drain will be placed with underwater seal drainage to drain residual air and fluid from the pleural cavity, allowing the lung to re -expand. The indications for removal of chest tubes will be absence of air leakage and cessation of fluid flow (100-150 mL daily).
The specimen prepared for frozen section will be placed on a metal tissue disc which is then secured in a chuck and frozen rapidly to about -20 to -30 °C. The specimen will be embedded in a gel like medium called optimal cutting temperature compound (OCT) and consisting of polyethylene glycol and polyvinyl alcohol. Subsequently it will be cut frozen with the microtome portion of the cryostat, the section will be picked up on a glass slide and stained (usually with hematoxylin and eosin, the H\&E stain).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients subjected for bronchoscopy or medical thoracoscopy | Other | Diagnostic Test: Bronchoscopic and thoracoscopic frozen section biopsiesBronchoscopic and thoracoscopic biopsies will be sent for both frozen section and permenant paraffin section |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presented with suspected lung neoplastic lesion indicated for bronchoscopy -
- Patients presented with undiagnosed pleural effusion (suspected malignant pleural effusion) who are candidate for thoracoscopy
Key exclusion criteria (10 listed)
- Age <18 years old.
- Contraindications for bronchoscopy:
- Contraindications for thoracoscopy:
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 |
|---|---|---|
| Bronchoscopic and thoracoscopic frozen section biopsiesFlexible bronchoscopy for patients with lung endobronchial lesion, the bronchoscopic biopsy will be sent for frozen section and permenant paraffin section Medical thoracoscopy for patients with undiagnosed pleural effusion, the thoracoscopic biopsy will be sent for both frozen section and permenant paraffin section | Diagnostic test | Patients subjected for bronchoscopy or medical thoracoscopy |
Primary outcome
determining the spceficity and sensitivity of bronhcoscopic and thoracoscopic frozen section biopsy
Time frame: 4 days
The accuracy of bronchoscopic and thoracoscopic frozen section to be malignant or non malignant or suspicious
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Background: PubMed 16268918Fielding D, Hopkins P, Serisier D. Frozen section of pleural biopsies at medical thoracoscopy assists in correctly identifying benign disease. Respirology. 2005 Nov;10(5):636-42. doi: 10.1111/j.1440-1843.2005.00761.x.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopic and thoracoscopic frozen section biopsies in people with Event of Undetermined Intent (Y21-Y33), run by Assiut University.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
determining the spceficity and sensitivity of bronhcoscopic and thoracoscopic frozen section biopsy (time frame: 4 days). 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 NCT05385419, 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 23 May 2022.