Modified Thoracoscopic Pleural Cryobiopsy in Diagnosis of Exudative Pleural Effusion

NCT04683419 | Unknown

• 1 other identifier: 0105678
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Rigid thoracoscopy is the gold standard tool for diagnosing exudative pleural effusion but sometimes it is difficult to obtain sufficient biopsies using the conventional forceps. Objectives: This study evaluated the efficacy, safety and diagnostic value of a modified technique using cryoprobe to obtain pleural biopsies during thoracoscopy. Methods: This is a single center prospective study in patients who will undergo rigid thoracoscopy using conventional rigid forceps followed by a cryoprobe from the same site after injection of subpleural mixture of adrenaline and xylocaine. Biopsies will be reviewed by an independent pathologist; any complications will be recorded, and all patients will be followed up post procedure.

Conditions

Pleural Effusion

Keywords

Thoracoscopy; Cryobiopsy

Outcome Measures

Primary Outcomes (3)

• Comparison between pleural biopsy specimens obtained by modified cryoprobe technique and conventional rigid forceps during medical thoracoscopy in diagnosis of pleural effusion regarding size of the obtained pleural biopsies.

  Size of the pleural biopsies obtained by both procedures will be compared in millimeters

  Immediately after ending the procedure

• Comparison between pleural biopsy specimens obtained by modified cryoprobe technique and conventional rigid forceps during medical thoracoscopy in diagnosis of pleural effusion regarding depth of the obtained pleural biopsies.

  Depth of the pleural biopsies obtained by both procedures will be compared by "grading of fat cells" Grading will be as follows: if there will be no presence of fat cells, this will be marked as negative and if less than 5% of the biopsy will be marked as + and if 5-25% of the biopsy will be marked as ++ and if more than 25% it will take +++ in both limbs of the cryo and forceps techniques.

  1 week

• Comparison between pleural biopsy specimens obtained by modified cryoprobe technique and conventional rigid forceps during medical thoracoscopy in diagnosis of pleural effusion regarding integrity of the obtained pleural biopsies.

  Integrity of the pleural biopsies obtained by both procedures will be compared by percentage of "crushed cells."" Grading will be as follows: if there will be no presence of crushed cells, this will be marked as negative and if less than 5% of the biopsy will be marked as + and if 5-25% of the biopsy will be marked as ++ and if more than 25% it will take +++ in both limbs of the cryo and forceps techniques.

  1 week

Secondary Outcomes (1)

• Safety of the procedure of thoracoscopic pleural biopsies

  During the period of hospital stay

Study Arms (1)

Patients with pleural effusion of Undetermined etiology

EXPERIMENTAL

Patients with undiagnosed exudative pleural effusion will undergo modified pleural cryobiopsies and conventional pleural forceps biopsies in the same settings

Device: Modified Thoracoscopic pleural Cryobiopsy

Interventions

Modified Thoracoscopic pleural Cryobiopsy DEVICE

Thoracoscopic pleural biopsy will be taken with a modified technique "raising of the parietal pleura by injection of saline, adrenaline and xylocaine, then taking the biopsy via a cryoprobe"

Patients with pleural effusion of Undetermined etiology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient with undiagnosed exudative pleural effusion

You may not qualify if:

• Any contraindications to medical thoracoscopy like:
• Inability to tolerate lateral decubitus position Unstable cardiovascular or hemodynamic status Presence of severe, uncorrectable hypoxemia despite oxygen therapy Bleeding diathesis Refractory cough Drug Hypersensitivity Reduced general health status with short suspected survival
• Refusal to participate

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Chest Department, Alexandria Faculty of Medicine

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Ayman I Baess, PhD

  Associate Professor of Chest diseases, Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayman I Baess, PhD

CONTACT

1006822068; ayman.baeis@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 24, 2020
• Study Start: November 11, 2020
• Primary Completion: January 10, 2021
• Study Completion: January 15, 2021
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)