Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
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ClinicalTrials.gov Identifier: NCT01366261 |
Recruitment Status
:
Completed
First Posted
: June 6, 2011
Last Update Posted
: November 11, 2011
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Condition or disease | Intervention/treatment | Phase |
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Pleural Diseases | Device: semirigid thoracoscopy Device: rigid thoracoscopy | Phase 3 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366261
Slovenia | |
University Clinic Golnik | |
Golnik 36, Golnik, Slovenia, 4204 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |