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

A Randomized Controlled 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.

Study Overview

• Status: Completed
• Conditions: Pleurisy With Effusion
• Intervention / Treatment: Device: Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany); Device: Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Postgraduate Institute of Medical Education and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield of thoracoscopic biopsy by intention to treat analysis	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yield of biopsies successfully completed	The diagnostic yield of only those procedures would be considered separately where a biopsy could be successfully done and compared between the two arms	3 months
Complications	Number of major and minor complications encountered in the two arms	3 months
Scar size	Scar size (in mm) in the longest axis	At the end of the procedure
Biopsy size	Biopsy size (in mm) in the longest axis	At the end of the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of sedation and analgesia during the procedure	The quantity of drugs used for sedation and analgesia during the procedure would be recorded and compared between the two arms	At the end of procedure
Operators' experience characteristics	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	At the end of the procedure

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Ritesh Agarwal, MD, DM, PGIMER, Chandigarh

Publications and helpful links

General Publications

• Dhooria S, Singh N, Aggarwal AN, Gupta D, Agarwal R. A randomized trial comparing the diagnostic yield of rigid and semirigid thoracoscopy in undiagnosed pleural effusions. Respir Care. 2014 May;59(5):756-64. doi: 10.4187/respcare.02738. Epub 2013 Oct 8.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 7, 2012
• First Submitted That Met QC Criteria: November 10, 2012
• First Posted (Estimate): November 15, 2012

Study Record Updates

• Last Update Posted (Estimate): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 9, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Pleural effusion; Semirigid thoracoscopy; Rigid thoracoscopy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion; Pleurisy
• Other Study ID Numbers: 1Trg-PG-2012/5054