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Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion

Primary Purpose

Pleura; Exudate

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thoracoscopy forceps
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleura; Exudate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients diagnosed as exudative pleural effusion according to Light criteria .informed written consents were taken from all patients enrolled in the study

Exclusion Criteria:

  • patients who refused participation ,patients unfit for medical thoracoscopy (MT) will be excluded from the study such as:Uncooperative patient ,Severe uncorrected hypoxemia in spite of continuous oxygen administration, because it's necessary to keep oxygen saturation above 90 % during procedure ,patients who could not tolerate the lateral decubitus position for a period long adequate to do the thoracoscopy, unstable cardiovascular or hemodynamic condition, uncorrected Coagulation defects and small pleural space

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I (Cryobiopsy group):

Group II (Forceps group)

Arm Description

patients where patients will be subjected to thoracoscopic cryobiopsy.

patients where patients will be subjected to thoracoscopic forceps biopsy.

Outcomes

Primary Outcome Measures

efficacy which determined by the diagnostic yield
comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield.
efficacy which determined by the size of biopsy
comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the size of biopsy.
The incidence of complications
comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications

Secondary Outcome Measures

Full Information

First Posted
February 14, 2021
Last Updated
March 11, 2021
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04761003
Brief Title
Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion
Official Title
Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To demonstrated the efficacy and safety of taking biopsy specimens from parietal pleura in undiagnosed exudative pleural effusion
Detailed Description
Pleural effusions are either transudate or exudate according to the biochemical analysis of aspirated pleural fluid. Thoracentesis or blind pleural biopsy may not provide a definitive diagnosis. Cryobiopsy has more successful diagnostic results than forceps biopsies with complications (only hemorrhage) during procedures. Cryobiopsy can obtain more diagnostic biopsies due to the size of the biopsies and best property in expressions of an artifact-free sample area

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleura; Exudate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A full medical history was obtained. Medical history, clinical examination and local chest examination for signs of pleural effusion, Radiological data include chest X-ray, chest computed tomography (CT), and chest ultrasound (US) for localization of a better entry site. Thoracoscopy procedure the procedure was performed in the lateral decubitus position with the affected side upward under conscious sedation. Local anesthesia consisting of 2% lignocaine was administered to the skin, subcutaneous tissue, muscle, and parietal pleura. The appearance of the parietal and visceral pleural was assessed and recorded. Pleural biopsies were obtained using rigid forceps and cryoprobe during rigid medical thoracoscopy Complications during thoracoscopy were recorded as bleeding and surgical emphysema. Samples were directly fixed in 10% formalin solution Biopsies obtained were examined pathologically with stress on size and quality of the sample.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (Cryobiopsy group):
Arm Type
Active Comparator
Arm Description
patients where patients will be subjected to thoracoscopic cryobiopsy.
Arm Title
Group II (Forceps group)
Arm Type
Active Comparator
Arm Description
patients where patients will be subjected to thoracoscopic forceps biopsy.
Intervention Type
Device
Intervention Name(s)
Thoracoscopy forceps
Other Intervention Name(s)
Thoracoscopic cryobiopsy
Intervention Description
take pleural biopsy
Primary Outcome Measure Information:
Title
efficacy which determined by the diagnostic yield
Description
comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the diagnostic yield.
Time Frame
baseline
Title
efficacy which determined by the size of biopsy
Description
comparing forceps biopsy and cryobiopsy as regard: efficacy which determined by the size of biopsy.
Time Frame
baseline
Title
The incidence of complications
Description
comparing forceps biopsy and cryobiopsy as regard: Safety which determined by the incidence of complications
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients diagnosed as exudative pleural effusion according to Light criteria .informed written consents were taken from all patients enrolled in the study Exclusion Criteria: patients who refused participation ,patients unfit for medical thoracoscopy (MT) will be excluded from the study such as:Uncooperative patient ,Severe uncorrected hypoxemia in spite of continuous oxygen administration, because it's necessary to keep oxygen saturation above 90 % during procedure ,patients who could not tolerate the lateral decubitus position for a period long adequate to do the thoracoscopy, unstable cardiovascular or hemodynamic condition, uncorrected Coagulation defects and small pleural space
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raed E ALI, MD
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed E Mansour, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
12806235
Citation
Light RW. Pleural diseases. Curr Opin Pulm Med. 2003 Jul;9(4):251-3. doi: 10.1097/00063198-200307000-00001. No abstract available.
Results Reference
result
PubMed Identifier
21213207
Citation
Noppen M. The utility of thoracoscopy in the diagnosis and management of pleural disease. Semin Respir Crit Care Med. 2010 Dec;31(6):751-9. doi: 10.1055/s-0030-1269835. Epub 2011 Jan 6.
Results Reference
result
PubMed Identifier
23411054
Citation
Porcel JM. Pleural fluid biomarkers: beyond the Light criteria. Clin Chest Med. 2013 Mar;34(1):27-37. doi: 10.1016/j.ccm.2012.11.002. Epub 2013 Jan 17.
Results Reference
result
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
result
PubMed Identifier
2920573
Citation
Bonniot JP, Homasson JP, Roden SL, Angebault ML, Renault PC. Pleural and lung cryobiopsies during thoracoscopy. Chest. 1989 Mar;95(3):492-3. doi: 10.1378/chest.95.3.492.
Results Reference
result
PubMed Identifier
18708736
Citation
Hetzel J, Hetzel M, Hasel C, Moeller P, Babiak A. Old meets modern: the use of traditional cryoprobes in the age of molecular biology. Respiration. 2008;76(2):193-7. doi: 10.1159/000135934. Epub 2008 Jun 26.
Results Reference
result
PubMed Identifier
16623208
Citation
Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20.
Results Reference
result

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Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion

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