Minirigid Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions

  • STATUS
    Recruiting
  • End date
    Mar 31, 2022
  • participants needed
    100
  • sponsor
    Postgraduate Institute of Medical Education and Research
Updated on 27 September 2021
thoracoscopy
pleural biopsy

Summary

Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study.

One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy to the following

groups

Group A (mini-thoracoscopy) Group B (Conventional rigid thoracoscopy) Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions

Description

A significant proportion of patients with pleural effusions remain undiagnosed after performance of diagnostic procedures including cytological and microbiologic analysis of the pleural fluid and closed pleural biopsies. In this study, the investigators plan to compare the yield and safety of mini-thoracoscopy and conventional rigid thoracoscopy with the larger diameter scope.

This is a prospective study that will be conducted at the Thoracic Endoscopy Suite of the Department of Pulmonary Medicine, PGIMER, Chandigarh.

Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study

One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy. The randomization sequence will be generated using a computer (in blocks of 10), and the allocation will be placed in opaque sealed envelopes. The patients will be randomized to the following groups:

Group A (mini-thoracoscopy): The mini-thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used. It has an outer diameter of 5.5 mm and a working channel diameter of 3.5 mm.

Group B (Conventional rigid thoracoscopy): The rigid thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used that has an outer diameter of 10 mm and channel internal diameter of 5 mm.

Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions.

Details
Condition Pleural disorder, Pleural Effusion, Pleural Diseases, pleural effusions
Treatment Mini-thoracoscopy, Conventional rigid thoraoscopy
Clinical Study IdentifierNCT03449602
SponsorPostgraduate Institute of Medical Education and Research
Last Modified on27 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Medical thoracoscopy being performed for obtaining a pleural biopsy

Exclusion Criteria

PaO2/FIO2< 300; Hemodynamic instability Myocardial infarction or unstable angina in the last 6 wk Lack of pleural space due to adhesions Uncorrected coagulopathy Failure to provide informed consent
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