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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years; 2. Patients with unilateral pleural effusion of unclear aetiology after less invasive means of diagnosis; 3. Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form. Exclusion Criteria: 1. Patients with PaO2/FiO2 \<300; 2. Patients with a tendency for uncontrolled bleeding, unstable cardiovascular status or severe heart failure; 3. Patients with complete pleural symphysis, where it was not possible to create a pneumothorax, were excluded subsequently; 4. Patients with refractory cough; 5. Patients with Eastern Cooperative Oncology Group performance status 4; 6. Patients did not agree to participate in this study; 7. Participation in other studies within three months without withdrawal or termination will affect the observation of this study.

Outcomes

Primary Outcomes

Diagnostic yield

Proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition.

Time frame: 7 days after the procedure.

Secondary Outcomes

Complications incidence

The incidence of procedure-related complications.

Time frame: 7 days after the procedure.

Size of specimen

Regarding biopsy size the total area is measured by the largest cross-sectional area under magnificence. Each sample was measured twice and the arithmetic mean of both measurements is accepted. All areas were calculated automatically and provided in mm2 by using ImageJ software (ImageJ, Marlyand, USA).

Time frame: Day 7 after procedure

Quality of specimen

Biopsy quality was determined by tissue depth. A thoracoscopic biopsy specimen, including fatty tissue of the thoracic wall, was considered to be a deep biopsy and therefore of high quality.

Time frame: 7 days after procedure

Interpretability of the specimen

The interpretability of specimens is assessed as below: 1. Easily interpretable: enough tissue with all elements required for diagnosis; 2. Interpretability with some difficulty: less tissue or fewer diagnostic elements, diagnosis less reliable; 3. Interpretable with great difficulty: little tissue or scant diagnostic elements, low reliability of diagnosis; 4. Non-interpretable: diagnosis not possible.