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

• ClinicalTrials.gov Identifier: NCT01366261
• Recruitment Status: Completed
• First Posted: June 6, 2011
• Last Update Posted: November 11, 2011
• Sponsor: Aleš Rozman
• Information provided by (Responsible Party): Aleš Rozman, The University Clinic of Pulmonary and Allergic Diseases Golnik

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pleural Diseases	Device: semirigid thoracoscopy; Device: rigid thoracoscopy	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
• Study Start Date: January 2008
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: November 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: semirigid thoracoscopy; thoracoscopy with semirigid instrument; Other Name: autoclavable Olympus LTF-160 (Olympus Tokyo, Japan)
Active Comparator: 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.	Device: rigid thoracoscopy; thoracoscopy with rigid instrument; Other Name: autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope

Outcome Measures

Primary Outcome Measures :

1. diagnostic adequacy of semirigid thoracoscopy [ Time Frame: 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 :

1. safety [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Slovenia

University Clinic Golnik

Golnik 36, Golnik, Slovenia, 4204

Sponsors and Collaborators

Aleš Rozman

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rozman A, Camlek L, Marc-Malovrh M, Triller N, Kern I. Rigid versus semi-rigid thoracoscopy for the diagnosis of pleural disease: a randomized pilot study. Respirology. 2013 May;18(4):704-10. doi: 10.1111/resp.12066.

• Responsible Party: Aleš Rozman, MD, The University Clinic of Pulmonary and Allergic Diseases Golnik
• ClinicalTrials.gov Identifier: NCT01366261 History of Changes
• Other Study ID Numbers: endo-0001
• First Posted: June 6, 2011
• Last Update Posted: November 11, 2011
• Last Verified: November 2011

Keywords provided by Aleš Rozman, The University Clinic of Pulmonary and Allergic Diseases Golnik:

Flex-rigid pleuroscopy; pleural biopsy; pleural effusion; safety; thoracoscopy

Additional relevant MeSH terms:

Pleural Diseases; Respiratory Tract Diseases