Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study

Aleš Rozman

Status and phase: Completed; Phase 3

Conditions: Pleural Diseases

Treatments: Device: rigid thoracoscopy; Device: semirigid thoracoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01366261

endo-0001

Details and patient eligibility

About

The purpose of our study was to compare the size and the quality of biopsy samples together with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in prospective, randomized fashion. The second aim was to compare safety and tolerability of both types of procedure, performed in local anesthesia with addition of intravenous sedation and analgesia.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 or more years old
• unilateral pleural effusion of unknown origin
• pleural irregularities suspicious for pleural malignancy
• referral for thoracoscopy after less invasive means of diagnosis had failed

Exclusion criteria

• uncontrolled bleeding tendency
• unstable cardiovascular status
• severe heart failure
• ECOG performance status 4
• persistent hypoxemia after evacuation of pleural fluid

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

semirigid thoracoscopy

Experimental group

Description:

Semirigid instrument which we compare was autoclavable Olympus LTF-160 (Olympus Tokyo, Japan). Handle and its controls were similar to flexible fiberoptic bronchoscope, with the insertion portion composed of 22 cm long rigid part and distal 5 cm flexible tip with angulation range 1600 up / 1300 down. The external diameter of insertion portion was 7 mm with 2,8 mm inner channel diameter. The instrument was compatible with Olympus EVIS Exera 160 and 145 and EVIS 100 and 140 video processors and light sources, otherwise employed in video-bronchoscopy. Forceps, which we used was flexible FB-55CD-1 Olympus forceps with 5 mm long cusps and diameter, which fitted the diameter of inner channel of semirigid thoracoscope.

Treatment:

Device: semirigid thoracoscopy

rigid thoracoscopy

Active Comparator group

Description:

The rigid instrument was autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope. The length of the instrument was 29 cm with 00 direction of view and 700 field of view. The external diameter of the instrument was 10 mm with 5,2 mm inner channel diameter. The instrument was compatible with Olympus Visera OTV-S7V and EVIS Exera II CV-180 video processors. Cusps of rigid forceps had outer diameter 5 mm and length 10 mm.

Treatment:

Device: rigid thoracoscopy