Mini Thoracoscopy vs Semirigid Thoracoscopy in Exudative Pleural Effusions

NCT02851927 | Completed DMC

• 1 other identifier: Mini vs Semirigid RCT
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Undiagnosed pleural effusion is a diagnostic dilemma especially in exudative pleural effusions (EPE). 20-40 % are unable to be attributed to a specific diagnosis, even after thoracentesis and closed pleural biopsy. Thoracoscopy has been demonstrated to increase the diagnostic yield in undiagnosed EPE. The diagnostic yield of thoracoscopy in malignant and TB pleural effusion ranges from 91% to 94% and 93% to 100%, respectively. Rigid thoracoscopy has traditionally been the modality of choice. The recently introduced semirigid thoracoscope provides ease of handling like a flexible bronchoscope. However, there are concerns about the diagnostic yield of semi-rigid thoracoscopy when compared with rigid thoracoscopy. According to the available literature, the yield of semirigid and rigid thoracoscopy is almost similar if adequate pleural biopsy is obtained. However there are concerns that with semi-rigid thoracoscope, there might be greater incidence of inability to obtain adequate pleural biopsy. On the other hand, the use of conventional rigid thoracoscope may be associated with greater procedure related pain.Mini-Thoracoscopy is a newer rigid thoracoscopy instrument which is smaller in diameter (5.5 mm) and may allow pleural biopsy with a smaller incision. There is scant literature on its utility. The investigators hereby propose to undertake a randomized comparison of rigid 'mini thoracoscope' vs semi rigid thoracoscope in undiagnosed pleural effusions.

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Diagnostic Yield

  Proportion of diagnostic biopsies in the two arms

  Through study completion, an average of 1 year

Secondary Outcomes (8)

• Sedation dose

  Through study completion, an average of 1 year

• Complications

  Through study completion, an average of 1 year

• Procedural pain

  Through study completion, an average of 1 year

• Operator rated pain

  Through study completion, an average of 1 year

• Operator rated overall procedure satisfaction

  Through study completion, an average of 1 year

Other Outcomes (4)

• Ease of biopsy

  Through study completion, an average of 1 year

• Operator rated pain on scope manipulation

  Through study completion, an average of 1 year

• Expectation of diagnostic biopsy

  Through study completion, an average of 1 year

Study Arms (2)

Mini Thoracoscopy

EXPERIMENTAL

Thoracoscopy procedure shall be performed using the Rigid Mini Thoracoscope

Procedure: Mini Thoracoscopy

Semirigid Thoracoscopy

ACTIVE COMPARATOR

Thoracoscopy procedure shall be performed using the SemiRigid Thoracoscope

Procedure: SemiRigid Thoracoscopy

Interventions

Mini Thoracoscopy PROCEDURE

Pleural biopsy using rigid mini thoracoscope

Mini Thoracoscopy

SemiRigid Thoracoscopy PROCEDURE

Pleural biopsy using semirigid thoracoscope

Semirigid Thoracoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years Presence of undiagnosed exudative pleural effusion as determined by the criteria detailed by Light et al where a specific diagnosis was not obtained after initial cytological and/or microbiological examinations.
• Adequate rib spaces for successful performance of thoracoscopy as judged by clinical examination Adequate pleural fluid space as judged by pre-procedural USG chest

You may not qualify if:

• Pregnancy
• Coagulopathy (platelet count \< 50000/mm3, INR \> 1.5)
• Unstable hemodynamic status ( SBP \> 180, DBP\> 100 or SBP\< 90 mm Hg / heart failure
• Myocardial infarction or unstable angina in the last 6 wk
• Hypoxemia not correctable with low flow oxygen (SpO2 \<90% despite low flow oxygen @ 1-2 l/min)
• Extensive rib crowding as judged by clinical examination
• Extensive adhesions and lack of pleural space on USG chest
• Refusal of consent

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Randeep Guleria, MD, DM

  AIIMS, New Delhi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Karan Madan MD, DM Assistant Professor

Study Record Dates

• First Submitted: May 1, 2016
• First Posted: August 2, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 27, 2018

Record last verified: 2018-12

Locations

IN (1)