Minirigid Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions

Pleural Effusion Clinical Trial

— MICRO  

Official title:

A Randomized Trial Comparing the Diagnostic Sensitivity and Safety of Mini-thoracoscopy Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03449602
• Other study ID #: NK/3695/Res
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2023
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Sahajal Dhooria, MD, DM
• Phone: +919530661388
• Email: sahajal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Device:
• Mini-thoracoscopy
Thoracoscopic pleural biopsy with the mini-thoracoscope
• Conventional rigid thoraoscopy
Thoracoscopic pleural biopsy with the conventional rigid thoraoscope

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic sensitivity (intention-to-treat)	Difference between the diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true positives diagnosed by thoracoscopic biopsy in the two groups out of the total diseased	6 months
Primary	Diagnostic sensitivity (per protocol)	Diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true positives diagnosed by thoracocopic biopsy. In this analysis, the subjects crossed over to the rigid group (due to failure of minirigid to yield biopsy tissue) will be considered in the rigid group	6 months
Secondary	Sedative and analgesic dose	Comparing doses of sedative and analgesic agents required in the two groups	1 day
Secondary	Pain scores by visual analog scale	Difference between intraoperative pain score associated with the use of the two devices (assessed after the procedure using the visual analog scale from 0-no pain to 100-maximum possible pain) in the two groups	1 day
Secondary	Diagnostic specificity	Difference between the diagnostic specificity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true negatives diagnosed by thoracoscopic biopsy in the two groups out of those not diseased	6 months
Secondary	Adverse effects	Differences between number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in the two groups	1 month
Secondary	Scope maneuverability	Differences between maneuverability of the two thoracoscopes on a visual analog scale (0-100 mm) assessed by the operator	1 day
Secondary	Ease of obtaining biopsy	Differences between ease of obtaining pleural biopsy with the two thoracoscopes on a visual analog scale (0-100 mm) assessed by the operator	1 day
Secondary	Incision size	Difference in the size of the incision required with the use of the two devices	1 day
Secondary	Procedure duration	Difference in the duration of procedure in the two groups	1 day
Secondary	Pain scores by Wong Baker FACES pain rating scale	Difference between intraoperative pain score associated with the use of the two devices (assessed after the procedure using the Wong Baker FACES pain rating scale) in the two groups	1 day