Medical Thoracoscopy With Flexible Bronchoscopy Versus Semi-Rigid Pleuroscope in Pleural Effusion (FLEXPLEUR)

NCT06162429 | Completed

• 1 other identifier: FF-2023-128
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

Pleural effusion is a common problem in hospital patients. It may arise from a wide range of diseases. There is a multitude of recognised causes of pleural effusion, and in addition, other pleural conditions such as pleural thickening and pneumothorax represent a significant burden to the healthcare system and to patients. However, the diagnosis of this condition may sometimes be difficult. In pleural effusions undiagnosed by thoracocentesis, closed pleural biopsy increases the yield by ∼10% and 40%, respectively, in malignant and tuberculous pleural effusions, whereas the diagnostic yield of thoracoscopy is ∼93% in both malignant and tuberculous pleural effusions. Hence, medical thoracoscopy (MT) (pleuroscopy) is the gold standard in the diagnosis of pleural effusion and it is indicated when less invasive tests have failed. MT is a procedure in which the pleura is directly and visually examined. An endoscope is inserted into the intercostal space by creating a pneumothorax with an incision through the chest wall. The pleural space and its lining can be inspected and therapeutic interventions performed. There are two different techniques that can be performed for diagnostic and therapeutic thoracoscopy. One method recommends a single-entry site, the use of a usually 9-mm rigid thoracoscope (or of a semi-rigid/semi-flexible 7-mm pleuroscope) with a working channel for accessory instruments and an optical biopsy forceps, both performed under local anaesthesia. The other method requires two entry sites: one for a 7-mm trocar for the examination telescope, and the other for a 5-mm trocar for accessory instruments including the biopsy forceps, and is usually performed with conscious sedation or general anaesthesia. In the trained hands of a pulmonologist, MT is a safe and effective procedure for diagnosing and treating multiple pleural diseases. Valsecchi et al reported a pathological diagnostic yield of 71% over a span of 30 years in around 2000 patients. The unfamiliarity of the pulmonary physician with the rigid instrument and familiarity with the flexible bronchoscope has led various investigators to attempt thoracoscopy even with a fibreoptic bronchoscope. The use of a flexible fibreoptic instrument to examine the pleural space was reported by Senno et al in the 1970s in the United States. Studies showed that flexible bronchoscope, when used as a thoracoscope, maintains a clear optical field by allowing concurrent suctioning, which is analogous to the suction techniques used during flexible bronchoscopy and better views at the apex and paravertebral gutters.This method is, therefore, considered to be useful for surgeons or physicians with experience in chest drainage and flexible bronchoscopy as well as safe and well tolerated with a minimal degree of discomfort and expense.

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• To compare the diagnostic yield (in percentage) using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.

  Subjects underwent medical thoracoscopy and the purpose is to compare the diagnostic yield, complication and duration of MT using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.

  between October 2017 to October 2022

Secondary Outcomes (3)

• To compare the rate of complication (in percentage) using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.

  between October 2017 to October 2022

• To compare the duration of procedure (in minutes) using flexible bronchoscopy versus semi-rigid pleuroscopy in hospital patients with pleural effusion.

  between October 2017 to October 2022

• To determine the predictors of diagnostic yield of flexible bronchoscope in hospital patients with pleural effusion

  between October 2017 to October 2022

Study Arms (2)

Flexible Thoracoscopy

Subjects with pleural effusion who underwent medical thoracoscopy using flexible bronchoscopy in the Respiratory Unit, Department of Internal Medicine, Faculty of Medicine UKM

Procedure: Flexible Bronchoscopy

Semi-Rigid Pleuroscopy

Subjects with pleural effusion who underwent semi-rigid pleuroscopy using flexible bronchoscopy in the Respiratory Unit, Department of Internal Medicine, Faculty of Medicine UKM

Procedure: Semi-Rigid Pleuroscopy

Interventions

Flexible Bronchoscopy PROCEDURE

Subjects with pleural effusion who underwent medical thoracoscopy using flexible bronchoscopy

Flexible Thoracoscopy

Semi-Rigid Pleuroscopy PROCEDURE

Subjects with pleural effusion who underwent medical thorascopy using semi-rigid pleuroscopy

Semi-Rigid Pleuroscopy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects admitted for pleural effusion who underwent a single MT with flexible bronchoscopy or semi-rigid pleuroscopy.

You may qualify if:

• Age 18 years and above
• Subjects admitted to Faculty of Medicine UKM during the study period and underwent a single MT with flexible bronchoscopy or semi-rigid pleuroscopy.

You may not qualify if:

• Age \< 18 years.
• Patients with incomplete data
• Patients' medical record that cannot be retrieved.

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

National University of Malaysia

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Mohamed Faisal Abdul Hamid, MBBS (IIUM)

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: December 8, 2023
• Study Start: January 31, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)