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
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: 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 by Postgraduate Institute of Medical Education and Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 01, 2014