Role of Cryobiopsy in Diagnosis of Pleural Effusion
Primary Purpose
Pleural Effusion
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cryoprobe
Sponsored by
About this trial
This is an interventional diagnostic trial for Pleural Effusion focused on measuring Cryobiopsy
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:
- 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.
-
Sites / Locations
- Assuit University hospital
- Alaa Salah Abdel gany
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pleural effusion patients
Arm Description
medical thoracoscopy will e performed to patients with pleural effusion and pleural biopsy by forceps ad cryoprobe will be obtained
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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 .
assessment pleural fluid
comparison between the estimate of pleural effusion using chest ultrasound and actual amount after thoracoscpic drainage, measured in mililiters.
assessment of post procedure pain
comparison between meperidine and (midazolam &NSAIDs) in controlling pain post thoracoscopy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03828903
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
October 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
Keywords
Cryobiopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pleural effusion patients
Arm Type
Experimental
Arm Description
medical thoracoscopy will e performed to patients with pleural effusion and pleural biopsy by forceps ad cryoprobe will be obtained
Intervention Type
Device
Intervention Name(s)
Cryoprobe
Intervention Description
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 Outcome Measure Information:
Title
comparison between pleural biopsy specimens obtained by flexible forceps with those obtained with cryoprobe during medical thoracoscopy in diagnosis of pleural effusion.
Description
1_size of pleural biopsy obtained by cryoprobe in comparison to those obtained by flexible forceps (in millimeter).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Complication assessment
Description
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 .
Time Frame
12 months
Title
assessment pleural fluid
Description
comparison between the estimate of pleural effusion using chest ultrasound and actual amount after thoracoscpic drainage, measured in mililiters.
Time Frame
12 months
Title
assessment of post procedure pain
Description
comparison between meperidine and (midazolam &NSAIDs) in controlling pain post thoracoscopy.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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:
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham M El morshedy, Lecturer
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuit University hospital
City
Assiut
ZIP/Postal Code
71511
Country
Egypt
Facility Name
Alaa Salah Abdel gany
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
29610630
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.
Results Reference
background
PubMed Identifier
29261578
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.
Results Reference
background
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Role of Cryobiopsy in Diagnosis of Pleural Effusion
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