A Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions (RISE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sahajal Dhooria, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01726556
First received: November 7, 2012
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument designed for the same purpose which is claimed to be more user-friendly. The two devices have not been compared in a head-to-head trial in published literature. The investigators attempt to conduct a randomised comparative trial between the two devices.


Condition Intervention
Pleurisy With Effusion
Device: Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)
Device: Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Diagnostic yield of thoracoscopic biopsy by intention to treat analysis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The proportion of patients where thoracoscopic pleural biopsy yielded a diagnosis that was consistent with the present clinical picture and the further follow-up of the patients, would be calculated and compared between the two arms


Secondary Outcome Measures:
  • Yield of biopsies successfully completed [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The diagnostic yield of only those procedures would be considered separately where a biopsy could be successfully done and compared between the two arms

  • Complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Number of major and minor complications encountered in the two arms

  • Scar size [ Time Frame: At the end of the procedure ] [ Designated as safety issue: No ]
    Scar size (in mm) in the longest axis

  • Biopsy size [ Time Frame: At the end of the procedure ] [ Designated as safety issue: No ]
    Biopsy size (in mm) in the longest axis


Other Outcome Measures:
  • Use of sedation and analgesia during the procedure [ Time Frame: At the end of procedure ] [ Designated as safety issue: No ]
    The quantity of drugs used for sedation and analgesia during the procedure would be recorded and compared between the two arms

  • Operators' experience characteristics [ Time Frame: At the end of the procedure ] [ Designated as safety issue: No ]
    These would include, on a numerical scale of 0 to 100, the operator's grading of the following characteristics: quality of thoracoscopic image, ease of maneuvering, ease of taking a biopsy and the operator's expectation that the biopsy will reveal a definitive histological diagnosis


Enrollment: 70
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rigid thoracoscopy
Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany.
Device: Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)
Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany
Active Comparator: Semirigid thoracoscopy
The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan.
Device: Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)
Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with an exudative (as defined by Light's criteria) pleural effusion of unknown etiology after a microbiological (namely gram stain and acid fast bacillus stain) and cytological examination

Exclusion Criteria:

  • Significant hypoxemia on room air
  • Hemodynamic instability
  • Significant cardiac disease (known myocardial infarction in last 6 weeks or presence of unstable angina)
  • Refractory cough
  • Lack of pleural space due to adhesions
  • Uncorrected coagulopathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726556

Locations
India
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Ritesh Agarwal, MD, DM PGIMER, Chandigarh
  More Information

No publications provided

Responsible Party: Sahajal Dhooria, Senior Resident, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01726556     History of Changes
Other Study ID Numbers: 1Trg-PG-2012/5054
Study First Received: November 7, 2012
Last Updated: January 9, 2013
Health Authority: India: Dept of Pulmonary Medicine, PIMER, Chandigarh

Keywords provided by Postgraduate Institute of Medical Education and Research:
Pleural effusion
Semirigid thoracoscopy
Rigid thoracoscopy

Additional relevant MeSH terms:
Pleural Effusion
Pleurisy
Pleural Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 16, 2014