Clinical trial NCT03449602: Minirigid Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions
Official title: A Randomized Trial Comparing the Diagnostic Sensitivity and Safety of Mini-thoracoscopy Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pleural Effusion
Keywords: thoracoscopy
pleuroscopy
metastatic cancer
lung cancer
malignant pleural effusion
tuberculosis
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2018-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic sensitivity (intention-to-treat)
timeFrame: 6 months
measure: Diagnostic sensitivity (per protocol)
timeFrame: 6 months
Secondary outcomes:
measure: Sedative and analgesic dose
timeFrame: 1 day
measure: Pain scores by visual analog scale
timeFrame: 1 day
measure: Diagnostic specificity
timeFrame: 6 months
measure: Adverse effects
timeFrame: 1 month
measure: Scope maneuverability
timeFrame: 1 day
measure: Ease of obtaining biopsy
timeFrame: 1 day
measure: Incision size
timeFrame: 1 day
measure: Procedure duration
timeFrame: 1 day
measure: Pain scores by Wong Baker FACES pain rating scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
References: