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

Primary Purpose

Pleurisy With Effusion

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)
Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleurisy With Effusion focused on measuring Pleural effusion, Semirigid thoracoscopy, Rigid thoracoscopy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Postgraduate Institute of Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rigid thoracoscopy

Semirigid thoracoscopy

Arm Description

Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany.

The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Complications
Number of major and minor complications encountered in the two arms
Scar size
Scar size (in mm) in the longest axis
Biopsy size
Biopsy size (in mm) in the longest axis

Full Information

First Posted
November 7, 2012
Last Updated
January 9, 2013
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01726556
Brief Title
A Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
Acronym
RISE
Official Title
A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleurisy With Effusion
Keywords
Pleural effusion, Semirigid thoracoscopy, Rigid thoracoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rigid thoracoscopy
Arm Type
Active Comparator
Arm Description
Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany.
Arm Title
Semirigid thoracoscopy
Arm Type
Active Comparator
Arm Description
The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan.
Intervention Type
Device
Intervention Name(s)
Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)
Intervention Description
Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany
Intervention Type
Device
Intervention Name(s)
Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)
Intervention Description
Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan
Primary Outcome Measure Information:
Title
Diagnostic yield of thoracoscopic biopsy by intention to treat analysis
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Yield of biopsies successfully completed
Description
The diagnostic yield of only those procedures would be considered separately where a biopsy could be successfully done and compared between the two arms
Time Frame
3 months
Title
Complications
Description
Number of major and minor complications encountered in the two arms
Time Frame
3 months
Title
Scar size
Description
Scar size (in mm) in the longest axis
Time Frame
At the end of the procedure
Title
Biopsy size
Description
Biopsy size (in mm) in the longest axis
Time Frame
At the end of the procedure
Other Pre-specified Outcome Measures:
Title
Use of sedation and analgesia during the procedure
Description
The quantity of drugs used for sedation and analgesia during the procedure would be recorded and compared between the two arms
Time Frame
At the end of procedure
Title
Operators' experience characteristics
Description
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
Time Frame
At the end of the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ritesh Agarwal, MD, DM
Organizational Affiliation
PGIMER, Chandigarh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
24106326
Citation
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.
Results Reference
derived

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

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