Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study - Full Text View

Purpose

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	Intervention	Phase
Pleural Diseases	Device: semirigid thoracoscopy Device: rigid thoracoscopy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Pleural Disorders

U.S. FDA Resources

Further study details as provided by The University Clinic of Pulmonary and Allergic Diseases Golnik:

Primary Outcome Measures:

diagnostic adequacy of semirigid thoracoscopy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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:

safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Major adverse events:
- bleeding
- infection
- reexpansion pulmonary edema
Minor adverse events:
- transient self-limited fever
- pain
- prolongued air leak
- subcutaneous emphysema
  
  30-day mortality


Enrollment:	84
Study Start Date:	January 2008
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366261

Locations


Slovenia
University Clinic Golnik
Golnik 36, Golnik, Slovenia, 4204

Sponsors and Collaborators

Aleš Rozman

More Information

No publications provided by The University Clinic of Pulmonary and Allergic Diseases Golnik

Additional 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
Study First Received:	May 31, 2011
Last Updated:	November 9, 2011
Health Authority:	Slovenia: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on March 03, 2015