Clinical trial NCT03828903: Role of Cryobiopsy in Diagnosis of Pleural Effusion
Official title: The Diagnostic Value of Cryobiopsy During Medical Thoracoscopy in Diagnosis of Pleural Effusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Keywords: Cryobiopsy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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:

1. Transudative pleural effusion.
2. Exudative pleural effusion less than one third of hemithorax.
3. Presence of hemorrhagic diathesis (prothrombin concentration \<50% and platelet count \<80,000/mm 3).
4. Poor performance state (ECOG performance status \>4) as recommended in BTS (British thoracic society) guidelines 2010.
5. Sever uncontrollable cough, hypercapnia and sever respiratory distress.
6. Fibrothorax, excessive pleural adhesion.

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Primary outcomes:
measure: comparison between pleural biopsy specimens obtained by flexible forceps with those obtained with cryoprobe during medical thoracoscopy in diagnosis of pleural effusion.
timeFrame: 12 months
Secondary outcomes:
measure: Complication assessment
timeFrame: 12 months
measure: assessment pleural fluid
timeFrame: 12 months
measure: assessment of post procedure pain
timeFrame: 12 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University hospital
city: Assiut
country: Egypt
facility: Alaa Salah Abdel gany
Study officials:
affiliation: Assiut University
name: Reham M El morshedy, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.