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Completed

NCT Number: NCT01726556

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

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.

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Key information

Conditions

Pleurisy With Effusion Pleural Diseases Pleural Effusion Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)

Device

Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany

Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)

Device

Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan

Primary outcomes

  1. Diagnostic yield of thoracoscopic biopsy by intention to treat analysis

    Time frame: 3 months

    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 outcomes

  1. Yield of biopsies successfully completed

    Time frame: 3 months

    The diagnostic yield of only those procedures would be considered separately where a biopsy could be successfully done and compared between the two arms

  2. Complications

    Time frame: 3 months

    Number of major and minor complications encountered in the two arms

  3. Scar size

    Time frame: At the end of the procedure

    Scar size (in mm) in the longest axis

  4. Biopsy size

    Time frame: At the end of the procedure

    Biopsy size (in mm) in the longest axis

Other outcomes

  1. Use of sedation and analgesia during the procedure

    Time frame: At the end of procedure

    The quantity of drugs used for sedation and analgesia during the procedure would be recorded and compared between the two arms

  2. Operators' experience characteristics

    Time frame: At the end of the procedure

    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

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions

Acronym: RISE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 15, 2012
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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