NCT01366261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 11, 2011

Status Verified

November 1, 2011

Enrollment Period

3.8 years

First QC Date

May 31, 2011

Last Update Submit

November 9, 2011

Conditions

Pleural Diseases

Keywords

Flex-rigid pleuroscopypleural biopsypleural effusionsafetythoracoscopy

Outcome Measures

Primary Outcomes (1)

  • 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)

    12 months

Secondary Outcomes (1)

  • safety

    1 month

Study Arms (2)

semirigid thoracoscopy

EXPERIMENTAL

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

rigid thoracoscopy

ACTIVE COMPARATOR

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

Interventions

semirigid thoracoscopyDEVICE

thoracoscopy with semirigid instrument

Also known as: autoclavable Olympus LTF-160 (Olympus Tokyo, Japan)
semirigid thoracoscopy
rigid thoracoscopyDEVICE

thoracoscopy with rigid instrument

Also known as: autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope
rigid thoracoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • uncontrolled bleeding tendency
  • unstable cardiovascular status
  • severe heart failure
  • ECOG performance status 4
  • persistent hypoxemia after evacuation of pleural fluid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic Golnik

Golnik, Golnik, 4204, Slovenia

Location

Related Publications (1)

  • 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.

    PMID: 23418922DERIVED

MeSH Terms

Conditions

Pleural DiseasesPleural Effusion

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 6, 2011

Study Start

January 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 11, 2011

Record last verified: 2011-11

Locations

SL(1)