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

NCT ID: NCT01366261

Last Updated: 2011-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-11-30

Brief Summary

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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

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Conditions

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Pleural Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

semirigid thoracoscopy

Intervention Type DEVICE

thoracoscopy with semirigid instrument

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.

Group Type ACTIVE_COMPARATOR

rigid thoracoscopy

Intervention Type DEVICE

thoracoscopy with rigid instrument

Interventions

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semirigid thoracoscopy

thoracoscopy with semirigid instrument

Intervention Type DEVICE

rigid thoracoscopy

thoracoscopy with rigid instrument

Intervention Type DEVICE

Other Intervention Names

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autoclavable Olympus LTF-160 (Olympus Tokyo, Japan) autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aleš Rozman

OTHER

Sponsor Role lead

Responsible Party

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Aleš Rozman

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University Clinic Golnik

Golnik, Golnik, Slovenia

Site Status

Countries

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Slovenia

References

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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.

Reference Type DERIVED
PMID: 23418922 (View on PubMed)

Other Identifiers

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endo-0001

Identifier Type: -

Identifier Source: org_study_id