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Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease

NCT ID: NCT06741839

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-31

Brief Summary

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A prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (nCLE) in the diagnosis of fibrinal pleurisy of unknown etiology. Patients with fibrinous pleurisy of unknown etiology who were to undergo thoracoscopic pleural biopsy were enrolled and informed consent was signed. Subjects were randomized to either the nCLE guided biopsy Group (Group A) or the visual biopsy group (Group B) according to the randomization table (1:1 ratio). nCLE was used to probe the benign and malignant status of pleural lesions, compare the consistency of random pathological biopsy or nCLE guided biopsy with histopathological results, compare whether nCLE guided biopsy can reduce the number of thoracoscopic biopsies, and follow up short-term postoperative complications to evaluate its safety.

Detailed Description

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Conditions

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Pleural Diseases Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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nCLE guided biopsy

Group Type EXPERIMENTAL

Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy

Intervention Type PROCEDURE

After the completion of the routine thoracoscopic examination, the biopsy location was determined based on the results of chest CT/ ultrasound. The benign and malignant states of pleural lesions were explored by nCLE and image records were collected. Then, the biopsy tissues were collected under the guidance of nCLE.

Visual biopsy

Group Type EXPERIMENTAL

Plerual biopsy using medical thoracoscopy

Intervention Type PROCEDURE

After the completion of the routine thoracoscopic examination, the biopsy location was determined according to the results of chest CT/ ultrasound, and random pathological biopsy was performed, and biopsy tissues were collected by biopsy forceps.

Interventions

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Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy

After the completion of the routine thoracoscopic examination, the biopsy location was determined based on the results of chest CT/ ultrasound. The benign and malignant states of pleural lesions were explored by nCLE and image records were collected. Then, the biopsy tissues were collected under the guidance of nCLE.

Intervention Type PROCEDURE

Plerual biopsy using medical thoracoscopy

After the completion of the routine thoracoscopic examination, the biopsy location was determined according to the results of chest CT/ ultrasound, and random pathological biopsy was performed, and biopsy tissues were collected by biopsy forceps.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with unilateral pleural effusion of unclear aetiology after less invasive means of diagnosis;
* Patients who intend to undergo a thoracoscopic pleural biopsy to determine the cause of pleural effusion;
* Sign informed consent.

Exclusion Criteria

* There is an uncorrectable coagulation disorder or anticoagulation therapy that cannot be stopped before surgery;
* Hemodynamic instability;
* Refractory hypoxemia;
* Patients with pregnant and lactating patients
* Any illness or condition that interferes with the completion of the initial or subsequent assessment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gang Hou

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Gang Hou

Role: CONTACT

Phone: 13840065481

Email: [email protected]

Other Identifiers

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2022YFC2404404-3-1

Identifier Type: -

Identifier Source: org_study_id