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Completed

NCT Number: NCT03828903

Role of Cryobiopsy 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alaa Salah Abdel gany, Asyut, Egypt

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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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Treatment and study plan

Cryoprobe

Device
  • 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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Complication assessment

    Time frame: 12 months

    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 .

  2. assessment pleural fluid

    Time frame: 12 months

    comparison between the estimate of pleural effusion using chest ultrasound and actual amount after thoracoscpic drainage, measured in mililiters.

  3. assessment of post procedure pain

    Time frame: 12 months

    comparison between meperidine and (midazolam &NSAIDs) in controlling pain post thoracoscopy.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

The Diagnostic Value of Cryobiopsy During Medical Thoracoscopy in Diagnosis of Pleural Effusion

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 4, 2019
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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