Dual-function Semirigid Thoracoscopy Versus Rigid Thoracoscopy for the Diagnosis of Pleural Disease

N/ANot Yet RecruitingNCT07114783

China-Japan Friendship Hospital92 enrolled

Overview

Medical thoracoscopy (rigid and semirigid) is an effective, safe method for diagnosing and managing pleural diseases. Rigid thoracoscopy demonstrates superior overall diagnostic yield compared to semirigid techniques (flexible forceps/cryobiopsy) due to its ability to obtain larger, deeper biopsies with rigid forceps. However, diagnostic rates become similar when biopsies are successfully obtained. Limitations of rigid thoracoscopy include restricted maneuverability (especially in posterior/mediastinal areas), increased procedural pain from leveraging against ribs and larger trocars, higher sedation requirements, and a steep learning curve for pulmonologists. To address these issues, a novel dual-function semirigid thoracoscope (UE FET-680, China) was developed. Its straight working channel accommodates standard rigid biopsy forceps, potentially matching rigid thoracoscopy's diagnostic yield while improving usability. This randomized trial will compare the efficacy and safety of this new device versus conventional rigid thoracoscopy in undiagnosed exudative pleural effusions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Pleural Effusion Disorder

Interventions

Outcomes

Primary Outcomes

Diagnostic yield

Diagnostic yield is defined as the percentage of participants for whom the allocated thoracoscopic pleural biopsy provides a specific histopathological diagnosis. Malignant pleural disease and other defined histopathological diagnoses will be classified as diagnostic results. Non-specific pleuritis, fibrinous pleuritis, non-interpretable specimens, and cases in which no biopsy is obtained will be classified as non-diagnostic results.

Time frame: 7 days after the procedure.

Secondary Outcomes

Procedural Sedative and Analgesic Requirements

Procedural sedative and analgesic requirements will be assessed by recording the total dose of each sedative or analgesic agent administered during thoracoscopy, including midazolam, pentazocine, and tramadol. The dose of each agent will be recorded separately in milligrams and summarised by treatment group

Time frame: The day of thoracoscopy.

Disease-specific Diagnostic Sensitivity

Disease-specific diagnostic sensitivity is defined as the percentage of participants with a specific final diagnosis according to the reference standard whose allocated thoracoscopic pleural biopsy provides a specific histopathological diagnosis supporting the same disease. Participants with non-specific biopsy findings who are subsequently diagnosed with malignant pleural disease or tuberculous pleuritis during follow-up will be classified as false-negative biopsy results for the corresponding disease.

Time frame: Up to 12 months after thoracoscopy.

Sampling Quality of Pleural Biopsy Specimens

Sampling quality will be assessed using specimen size, specimen depth, and specimen interpretability. Specimen size will be measured as the largest cross-sectional area of the processed biopsy specimens on microscopic glass slides using ImageJ software and reported in square millimetres. Specimen depth will be assessed according to the presence of thoracic wall fatty tissue. Specimen interpretability will be classified as easily interpretable, interpretable with some difficulty, interpretable with great difficulty, or non-interpretable.

Time frame: Up to 4 weeks after thoracoscopy.

Procedure Duration

Procedure duration will be measured in minutes from skin incision to completion of chest tube placement and wound closure.

Time frame: The day of thoracoscopy.

Operator-assessed Device Performance

Operator-assessed device performance will include image quality, ease of manoeuvring, ease of obtaining a biopsy sample, and the operator's expectation that the biopsy sample will provide a definitive histological diagnosis. Each domain will be assessed immediately after the procedure using a visual analogue scale ranging from 0 to 100, with higher scores indicating better operator-assessed performance.

Time frame: Immediately after the thoracoscopic procedure

Post-thoracoscopy Pain Score

Patient-reported post-thoracoscopy pain will be assessed using a 100-mm visual analogue scale while at rest and while coughing. Scores range from 0 to 100, with higher scores indicating more severe pain.

Time frame: At 2, 6, 12, 24, and 48 hours after thoracoscopy

Procedure-related Complications

Procedure-related complications will be classified as major or minor complications. Major complications include empyema, major haemorrhage defined as a drop in haemoglobin of at least 1 g/dL or requiring blood transfusion, persistent air leak for more than 3 days, and re-expansion pulmonary oedema. Minor complications include subcutaneous emphysema, operative site infection, non-infective fever, and minor haemorrhage.

Time frame: At discharge from the index hospitalization, up to 30 days after thoracoscopy.