Pleura; ExudateNCT04761003
Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion
A study testing Thoracoscopy forceps in people with Pleura; Exudate, run by Mansoura University at 1 site in Egypt.
Trial summary
To demonstrated the efficacy and safety of taking biopsy specimens from parietal pleura in undiagnosed exudative pleural effusion Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pleura; Exudate
- What is being tested?
- Thoracoscopy forceps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Mar 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients diagnosed as exudative pleural effusion according to Light criteria .informed written consents were taken from all patients enrolled in the study
Who cannot join
- patients who refused participation ,patients unfit for medical thoracoscopy (MT) will be excluded from the study such as:Uncooperative patient ,Severe uncorrected hypoxemia in spite of continuous oxygen administration, because it's necessary to keep oxygen saturation above 90 % during procedure ,patients who could not tolerate the lateral decubitus position for a period long adequate to do the thoracoscopy, unstable cardiovascular or hemodynamic condition, uncorrected Coagulation defects and small pleural space
Trial locations and contacts
1 site in 1 country.
About this study
To demonstrated the efficacy and safety of taking biopsy specimens from parietal pleura in undiagnosed exudative pleural effusion
Read the detailed description
Pleural effusions are either transudate or exudate according to the biochemical analysis of aspirated pleural fluid. Thoracentesis or blind pleural biopsy may not provide a definitive diagnosis. Cryobiopsy has more successful diagnostic results than forceps biopsies with complications (only hemorrhage) during procedures. Cryobiopsy can obtain more diagnostic biopsies due to the size of the biopsies and best property in expressions of an artifact-free sample area
- Conditions
- Pleura; Exudate
- Being tested
- Thoracoscopy forceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoscopy forcepsDevice
Also called Thoracoscopic cryobiopsy
take pleural biopsy
| Study group | Role | What they receive |
|---|---|---|
| Group I (Cryobiopsy group): | Active comparator | patients where patients will be subjected to thoracoscopic cryobiopsy. Receives: Device: Thoracoscopy forceps |
| Group II (Forceps group) | Active comparator | patients where patients will be subjected to thoracoscopic forceps biopsy. Receives: Device: Thoracoscopy forceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy which determined by the diagnostic yield
comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield.
Measured: baseline
efficacy which determined by the size of biopsy
comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the size of biopsy.
Measured: baseline
The incidence of complications
comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jan 2021
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pleura; ExudateStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A full medical history was obtained. Medical history, clinical examination and local chest examination for signs of pleural effusion, Radiological data include chest X-ray, chest computed tomography (CT), and chest ultrasound (US) for localization of a better entry site. Thoracoscopy procedure the procedure was performed in the lateral decubitus position with the affected side upward under conscious sedation. Local anesthesia consisting of 2% lignocaine was administered to the skin, subcutaneous tissue, muscle, and parietal pleura. The appearance of the parietal and visceral pleural was assessed and recorded. Pleural biopsies were obtained using rigid forceps and cryoprobe during rigid medical thoracoscopy Complications during thoracoscopy were recorded as bleeding and surgical emphysema. Samples were directly fixed in 10% formalin solution Biopsies obtained were examined pathologically with stress on size and quality of the sample.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Awad, Mansoura University
- Investigators
- Raed E ALI, MD, Study chair, Mansoura UniversityAhmed E Mansour, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761003
- Sponsor's protocol ID
- Thoracoscopic cryobiopsy
- Status last verified
- Mar 2021
- First submitted
- 14 Feb 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Light RW. Pleural diseases. Curr Opin Pulm Med. 2003 Jul;9(4):251-3. doi: 10.1097/00063198-200307000-00001. No abstract available.
PubMed 12806235Noppen M. The utility of thoracoscopy in the diagnosis and management of pleural disease. Semin Respir Crit Care Med. 2010 Dec;31(6):751-9. doi: 10.1055/s-0030-1269835. Epub 2011 Jan 6.
PubMed 21213207Porcel JM. Pleural fluid biomarkers: beyond the Light criteria. Clin Chest Med. 2013 Mar;34(1):27-37. doi: 10.1016/j.ccm.2012.11.002. Epub 2013 Jan 17.
PubMed 23411054Tousheed SZ, Manjunath PH, Chandrasekar S, Murali Mohan BV, Kumar H, Hibare KR, Ramanjaneya R. Cryobiopsy of the Pleura: An Improved Diagnostic Tool. J Bronchology Interv Pulmonol. 2018 Jan;25(1):37-41. doi: 10.1097/LBR.0000000000000444.
PubMed 29261578Bonniot JP, Homasson JP, Roden SL, Angebault ML, Renault PC. Pleural and lung cryobiopsies during thoracoscopy. Chest. 1989 Mar;95(3):492-3. doi: 10.1378/chest.95.3.492.
PubMed 2920573Hetzel J, Hetzel M, Hasel C, Moeller P, Babiak A. Old meets modern: the use of traditional cryoprobes in the age of molecular biology. Respiration. 2008;76(2):193-7. doi: 10.1159/000135934. Epub 2008 Jun 26.
PubMed 18708736Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20.
PubMed 16623208
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion
- ClinicalTrials.gov ID
- NCT04761003
- Acronym / sponsor ID
- Thoracoscopic cryobiopsy
- Conditions
- Pleura; Exudate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 18 Feb 2021 (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.
To demonstrated the efficacy and safety of taking biopsy specimens from parietal pleura in undiagnosed exudative pleural effusion
Detailed description
Pleural effusions are either transudate or exudate according to the biochemical analysis of aspirated pleural fluid. Thoracentesis or blind pleural biopsy may not provide a definitive diagnosis. Cryobiopsy has more successful diagnostic results than forceps biopsies with complications (only hemorrhage) during procedures. Cryobiopsy can obtain more diagnostic biopsies due to the size of the biopsies and best property in expressions of an artifact-free sample area
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A full medical history was obtained. Medical history, clinical examination and local chest examination for signs of pleural effusion, Radiological data include chest X-ray, chest computed tomography (CT), and chest ultrasound (US) for localization of a better entry site. Thoracoscopy procedure the procedure was performed in the lateral decubitus position with the affected side upward under conscious sedation. Local anesthesia consisting of 2% lignocaine was administered to the skin, subcutaneous tissue, muscle, and parietal pleura. The appearance of the parietal and visceral pleural was assessed and recorded. Pleural biopsies were obtained using rigid forceps and cryoprobe during rigid medical thoracoscopy Complications during thoracoscopy were recorded as bleeding and surgical emphysema. Samples were directly fixed in 10% formalin solution Biopsies obtained were examined pathologically with stress on size and quality of the sample.
| Arm | Type | Receives |
|---|---|---|
| Group I (Cryobiopsy group): | Active comparator | Device: Thoracoscopy forcepspatients where patients will be subjected to thoracoscopic cryobiopsy. |
| Group II (Forceps group) | Active comparator | Device: Thoracoscopy forcepspatients where patients will be subjected to thoracoscopic forceps biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed as exudative pleural effusion according to Light criteria .informed written consents were taken from all patients enrolled in the study
Key exclusion criteria (1 listed)
- patients who refused participation ,patients unfit for medical thoracoscopy (MT) will be excluded from the study such as:Uncooperative patient ,Severe uncorrected hypoxemia in spite of continuous oxygen administration, because it's necessary to keep oxygen saturation above 90 % during procedure ,patients who could not tolerate the lateral decubitus position for a period long adequate to do the thoracoscopy, unstable cardiovascular or hemodynamic condition, uncorrected Coagulation defects and small pleural space
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 |
|---|---|---|
| Thoracoscopy forcepsAlso: Thoracoscopic cryobiopsytake pleural biopsy | Device | Group I (Cryobiopsy group):, Group II (Forceps group) |
Primary outcome
efficacy which determined by the diagnostic yield
Time frame: baseline
comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield.
efficacy which determined by the size of biopsy
Time frame: baseline
comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the size of biopsy.
The incidence of complications
Time frame: baseline
comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications
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 15 Mar 2021.
- Results publication: PubMed 12806235Light RW. Pleural diseases. Curr Opin Pulm Med. 2003 Jul;9(4):251-3. doi: 10.1097/00063198-200307000-00001. No abstract available.
- Results publication: PubMed 21213207Noppen M. The utility of thoracoscopy in the diagnosis and management of pleural disease. Semin Respir Crit Care Med. 2010 Dec;31(6):751-9. doi: 10.1055/s-0030-1269835. Epub 2011 Jan 6.
- Results publication: PubMed 23411054Porcel JM. Pleural fluid biomarkers: beyond the Light criteria. Clin Chest Med. 2013 Mar;34(1):27-37. doi: 10.1016/j.ccm.2012.11.002. Epub 2013 Jan 17.
- Results publication: PubMed 29261578Tousheed SZ, Manjunath PH, Chandrasekar S, Murali Mohan BV, Kumar H, Hibare KR, Ramanjaneya R. Cryobiopsy of the Pleura: An Improved Diagnostic Tool. J Bronchology Interv Pulmonol. 2018 Jan;25(1):37-41. doi: 10.1097/LBR.0000000000000444.
- Results publication: PubMed 2920573Bonniot JP, Homasson JP, Roden SL, Angebault ML, Renault PC. Pleural and lung cryobiopsies during thoracoscopy. Chest. 1989 Mar;95(3):492-3. doi: 10.1378/chest.95.3.492.
- Results publication: PubMed 18708736Hetzel J, Hetzel M, Hasel C, Moeller P, Babiak A. Old meets modern: the use of traditional cryoprobes in the age of molecular biology. Respiration. 2008;76(2):193-7. doi: 10.1159/000135934. Epub 2008 Jun 26.
- Results publication: PubMed 16623208Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20.
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.
Raed E ALI, MD study chair
Mansoura University
Ahmed E Mansour, MD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracoscopy forceps in people with Pleura; Exudate, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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 15 Mar 2021. 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 Egypt. 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?
efficacy which determined by the diagnostic yield (time frame: baseline). The study lists 3 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 NCT04761003, which also lists 7 linked publications.
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 15 Mar 2021.