- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03828903
Role of Cryobiopsy in Diagnosis of Pleural Effusion
The Diagnostic Value of Cryobiopsy During Medical Thoracoscopy in Diagnosis of Pleural Effusion
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Assiut, Egypt, 71511
- Assuit University Hospital
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Assiut, Egypt
- Alaa Salah Abdel gany
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pleural effusion patients
medical thoracoscopy will e performed to patients with pleural effusion and pleural biopsy by forceps ad cryoprobe will be obtained
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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1_size of pleural biopsy obtained by cryoprobe in comparison to those obtained by flexible forceps (in millimeter).
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complication assessment
Time Frame: 12 months
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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 . |
12 months
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assessment pleural fluid
Time Frame: 12 months
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comparison between the estimate of pleural effusion using chest ultrasound and actual amount after thoracoscpic drainage, measured in mililiters.
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12 months
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assessment of post procedure pain
Time Frame: 12 months
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comparison between meperidine and (midazolam &NSAIDs) in controlling pain post thoracoscopy.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Reham M El morshedy, Lecturer, Assiut University
Publications and helpful links
General 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.
- Tousheed 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cryobiopsy pleural effusion
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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