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

Phase 3

Completed

• Conditions: Pleural Diseases
• Interventions: Device: rigid thoracoscopy; Device: semirigid thoracoscopy

• Registration Number: NCT01366261
• Lead Sponsor: Aleš Rozman

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-06
• Status Verified: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-09
• Last Update Posted: 2011-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rigid thoracoscopy	rigid thoracoscopy	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.
semirigid thoracoscopy	semirigid thoracoscopy	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.

Primary Outcome Measures

Name	Time	Method
diagnostic adequacy of semirigid thoracoscopy	12 months	* comparison of diagnostic adequacy of both instruments (number of definitive diagnosis in each group); * size of the biopsy specimens in mm2; * interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible)

Secondary Outcome Measures

Name	Time	Method
safety	1 month	Major adverse events: * bleeding; * infection; * reexpansion pulmonary edema; Minor adverse events: * transient self-limited fever; * pain; * prolongued air leak; * subcutaneous emphysema; 30-day mortality

Trial Locations

Locations (1)

University Clinic Golnik; 🇸🇮 Golnik 36, Golnik, Slovenia