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

Primary Purpose

Pleural Diseases

Status
Completed
Phase
Phase 3
Locations
Slovenia
Study Type
Interventional
Intervention
semirigid thoracoscopy
rigid thoracoscopy
Sponsored by
Aleš Rozman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleural Diseases focused on measuring Flex-rigid pleuroscopy, pleural biopsy, pleural effusion, safety, thoracoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Clinic Golnik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

semirigid thoracoscopy

rigid thoracoscopy

Arm 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.

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.

Outcomes

Primary Outcome Measures

diagnostic adequacy of semirigid thoracoscopy
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
Major adverse events: bleeding infection reexpansion pulmonary edema Minor adverse events: transient self-limited fever pain prolongued air leak subcutaneous emphysema 30-day mortality

Full Information

First Posted
May 31, 2011
Last Updated
November 9, 2011
Sponsor
Aleš Rozman
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1. Study Identification

Unique Protocol Identification Number
NCT01366261
Brief Title
Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
Official Title
Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aleš Rozman

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Diseases
Keywords
Flex-rigid pleuroscopy, pleural biopsy, pleural effusion, safety, thoracoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
semirigid thoracoscopy
Arm Type
Experimental
Arm 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.
Arm Title
rigid thoracoscopy
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
semirigid thoracoscopy
Other Intervention Name(s)
autoclavable Olympus LTF-160 (Olympus Tokyo, Japan)
Intervention Description
thoracoscopy with semirigid instrument
Intervention Type
Device
Intervention Name(s)
rigid thoracoscopy
Other Intervention Name(s)
autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope
Intervention Description
thoracoscopy with rigid instrument
Primary Outcome Measure Information:
Title
diagnostic adequacy of semirigid thoracoscopy
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
safety
Description
Major adverse events: bleeding infection reexpansion pulmonary edema Minor adverse events: transient self-limited fever pain prolongued air leak subcutaneous emphysema 30-day mortality
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Clinic Golnik
City
Golnik 36
State/Province
Golnik
ZIP/Postal Code
4204
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23418922
Citation
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.
Results Reference
derived

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

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