Pleural EffusionNCT03828903
Role of Cryobiopsy in Diagnosis of Pleural Effusion
A study testing Cryoprobe in people with Pleural Effusion, run by Assiut University at 2 sites in Egypt.
Trial summary
The purpose of this study is to evaluate the feasibility, size and quality of the specimens obtained by cryoprobe in comparison to those specimens obtained by flexible forceps during medical thoracoscopy in diagnosis of pleural effusion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Cryoprobe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Mar 2020to 10 Oct 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Unilateral moderate or massive exudative pleural effusion patients. 2. Undiagnosed pleural effusion after simple pleural fluid aspiration, cytology or blind (closed) pleural biopsy using Abram's needle.
- 3. Age>18 years old
Who cannot join
- Transudative pleural effusion.
- Exudative pleural effusion less than one third of hemithorax.
- Presence of hemorrhagic diathesis (prothrombin concentration <50% and platelet count <80,000/mm 3).
- Poor performance state (ECOG performance status >4) as recommended in BTS (British thoracic society) guidelines 2010.
- Sever uncontrollable cough, hypercapnia and sever respiratory distress.
- Fibrothorax, excessive pleural adhesion.
- -
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Diagnostic Value of Cryobiopsy During Medical Thoracoscopy in Diagnosis of Pleural Effusion
The purpose of this study is to evaluate the feasibility, size and quality of the specimens obtained by cryoprobe in comparison to those specimens obtained by flexible forceps during medical thoracoscopy in diagnosis of pleural effusion.
Read the detailed description
- Medical thoracoscopy with single-port-of-entry technique will be performed in the bronchoscopy unit under local anesthesia and conscious sedation using midazolam (2 mg) or pethidin.
- 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 trocar to be used, usually of approximately 10 mm, parallel with and in the middle of the selected intercostal space.
- Then the trocar will be inserted until the sudden release of resistance (after passing the costal pleura) is felt.
- 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 will be biopsied through the working channel of the thoracoscope.
- two to six biopsies of a suspicious pleural lesion will establish the diagnosis.
Technique of pleural biopsy using cryotechnique:
- The probe (ERBE Elektromedizin GmbH( Gesellschaft mit beschränkter Haftung) , Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization.
- The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch.
- carbon dioxide will be used as the cryogen gas for cryobiopsy
- The frozen tissue is going to be extracted by gently pulling of the probe.
- Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture.
- Conditions
- Pleural Effusion
- Being tested
- Cryoprobe
- Keywords
- Cryobiopsy
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoprobeDevice
- The probe (ERBE Elektromedizin GmbH; Tubingen, Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization.
- The tip of the cryoprobe will be attached to suspicious part of parietal pleura .
- The frozen tissue is going to be extracted by gently pulling of the probe.
- Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture.
- The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar.
- The biopsy sample will be released from the probe by thawing in the saline.
- The semirigid pleuroscope will be reintroduced through the port and the pleura will be revisualized for bleeding.
| Study group | Role | What they receive |
|---|---|---|
| pleural effusion patients | Experimental | medical thoracoscopy will e performed to patients with pleural effusion and pleural biopsy by forceps ad cryoprobe will be obtained Receives: Device: Cryoprobe |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between pleural biopsy specimens obtained by flexible forceps with those obtained with cryoprobe during medical thoracoscopy in diagnosis of pleural effusion.
1_size of pleural biopsy obtained by cryoprobe in comparison to those obtained by flexible forceps (in millimeter).
Measured: 12 months
Secondary outcomes (3)
Complication assessment
To evaluate the safety and occurrence of complication such as bleeding Number of patients with a certain degree of bleeding from biopsy site, described as:
1 = slight, self-limited, 2 = moderate, requiring electrocautery intervention, 3 = severe, requiring interruption of the procedure, chest tube drainage and intravenous fluid resuscitation .
Measured: 12 months
assessment pleural fluid
comparison between the estimate of pleural effusion using chest ultrasound and actual amount after thoracoscpic drainage, measured in mililiters.
Measured: 12 months
assessment of post procedure pain
comparison between meperidine and (midazolam \&NSAIDs) in controlling pain post thoracoscopy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start10 Mar 2020
- Primary completion10 Sep 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Salah Abd El Ghany, Assiut University
- Investigators
- Reham M El morshedy, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828903
- Sponsor's protocol ID
- Cryobiopsy pleural effusion
- Status last verified
- Oct 2021
- First submitted
- 26 Jan 2019
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen CH, Cheng WC, Wu BR, Chen CY, Chen WC, Liao WC, Tu CY. Feasibility and Safety of Pleuroscopic Cryobiopsy of the Pleura: A Prospective Study. Can Respir J. 2018 Jan 22;2018:6746470. doi: 10.1155/2018/6746470. eCollection 2018.
PubMed 29610630Tousheed 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 29261578
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Cryobiopsy During Medical Thoracoscopy in Diagnosis of Pleural Effusion
- ClinicalTrials.gov ID
- NCT03828903
- Acronym / sponsor ID
- Cryobiopsy pleural effusion
- Conditions
- Pleural Effusion
- Keywords
- Cryobiopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 4 Feb 2019 (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.
The purpose of this study is to evaluate the feasibility, size and quality of the specimens obtained by cryoprobe in comparison to those specimens obtained by flexible forceps during medical thoracoscopy in diagnosis of pleural effusion.
Detailed description
- Medical thoracoscopy with single-port-of-entry technique will be performed in the bronchoscopy unit under local anesthesia and conscious sedation using midazolam (2 mg) or pethidin.
- 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 trocar to be used, usually of approximately 10 mm, parallel with and in the middle of the selected intercostal space.
- Then the trocar will be inserted until the sudden release of resistance (after passing the costal pleura) is felt.
- 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 will be biopsied through the working channel of the thoracoscope.
- two to six biopsies of a suspicious pleural lesion will establish the diagnosis.
Technique of pleural biopsy using cryotechnique:
- The probe (ERBE Elektromedizin GmbH( Gesellschaft mit beschränkter Haftung) , Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization.
- The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch.
- carbon dioxide will be used as the cryogen gas for cryobiopsy
- The frozen tissue is going to be extracted by gently pulling of the probe.
- Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pleural effusion patients | Experimental | Device: Cryoprobemedical thoracoscopy will e performed to patients with pleural effusion and pleural biopsy by forceps ad cryoprobe will be obtained |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Unilateral moderate or massive exudative pleural effusion patients. 2. Undiagnosed pleural effusion after simple pleural fluid aspiration, cytology or blind (closed) pleural biopsy using Abram's needle.
- 3. Age>18 years old
Key exclusion criteria (7 listed)
- Transudative pleural effusion.
- Exudative pleural effusion less than one third of hemithorax.
- Presence of hemorrhagic diathesis (prothrombin concentration <50% and platelet count <80,000/mm 3).
- Poor performance state (ECOG performance status >4) as recommended in BTS (British thoracic society) guidelines 2010.
- Sever uncontrollable cough, hypercapnia and sever respiratory distress.
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 |
|---|---|---|
| Cryoprobe* The probe (ERBE Elektromedizin GmbH; Tubingen, Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization. * The tip of the cryoprobe will be attached to suspicious part of parietal pleura . * The frozen tissue is going to be extracted by gently pulling of the probe. * Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture. * The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. * The biopsy sample will be released from the probe by thawing in the saline. * The semirigid pleuroscope will be reintroduced through the port and the pleura will be revisualized for bleeding. | Device | pleural effusion patients |
Primary outcome
comparison between pleural biopsy specimens obtained by flexible forceps with those obtained with cryoprobe during medical thoracoscopy in diagnosis of pleural effusion.
Time frame: 12 months
1_size of pleural biopsy obtained by cryoprobe in comparison to those obtained by flexible forceps (in millimeter).
3 secondary outcomes
Complication assessment
Time frame: 12 months
assessment pleural fluid
Time frame: 12 months
assessment of post procedure pain
Time frame: 12 months
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 9 Dec 2021.
- Background: PubMed 29610630Chen CH, Cheng WC, Wu BR, Chen CY, Chen WC, Liao WC, Tu CY. Feasibility and Safety of Pleuroscopic Cryobiopsy of the Pleura: A Prospective Study. Can Respir J. 2018 Jan 22;2018:6746470. doi: 10.1155/2018/6746470. eCollection 2018.
- Background: 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.
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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.
Reham M El morshedy, Lecturer principal investigator
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoprobe in people with Pleural Effusion, run by Assiut University at 2 sites 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 2 inclusion and 7 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
comparison between pleural biopsy specimens obtained by flexible forceps with those obtained with cryoprobe during medical thoracoscopy in diagnosis of pleural effusion. (time frame: 12 months). 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 NCT03828903, which also lists 2 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 9 Dec 2021.