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Trial record 2 of 62 for:    Recruiting, Not yet recruiting, Available Studies | "Pleural Effusion"

Minirigid Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions (MICRO)

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ClinicalTrials.gov Identifier: NCT03449602
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Sahajal Dhooria, Postgraduate Institute of Medical Education and Research

Brief Summary:

Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study.

One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy to the following groups:

Group A (mini-thoracoscopy) Group B (Conventional rigid thoracoscopy) Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions


Condition or disease Intervention/treatment Phase
Pleural Effusion Device: Mini-thoracoscopy Device: Conventional rigid thoraoscopy Not Applicable

Detailed Description:

A significant proportion of patients with pleural effusions remain undiagnosed after performance of diagnostic procedures including cytological and microbiologic analysis of the pleural fluid and closed pleural biopsies. In this study, the investigators plan to compare the yield and safety of mini-thoracoscopy and conventional rigid thoracoscopy with the larger diameter scope.

This is a prospective study that will be conducted at the Thoracic Endoscopy Suite of the Department of Pulmonary Medicine, PGIMER, Chandigarh.

Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study

One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy. The randomization sequence will be generated using a computer (in blocks of 10), and the allocation will be placed in opaque sealed envelopes. The patients will be randomized to the following groups:

Group A (mini-thoracoscopy): The mini-thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used. It has an outer diameter of 5.5 mm and a working channel diameter of 3.5 mm.

Group B (Conventional rigid thoracoscopy): The rigid thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used that has an outer diameter of 10 mm and channel internal diameter of 5 mm.

Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Randomized Trial Comparing the Diagnostic Sensitivity and Safety of Mini-thoracoscopy Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Mini-thoraoscopy
The mini-thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used for performing thoracoscopic pleural biopsies. It has an outer diameter of 5.5 mm and a working channel diameter of 3.5 mm.
Device: Mini-thoracoscopy
Thoracoscopic pleural biopsy with the mini-thoracoscope

Active Comparator: Conventional rigid thoracoscopy
The rigid thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used for performing thoracoscopic pleural biopsies. It has an outer diameter of 10 mm and channel internal diameter of 5 mm.
Device: Conventional rigid thoraoscopy
Thoracoscopic pleural biopsy with the conventional rigid thoraoscope




Primary Outcome Measures :
  1. Diagnostic sensitivity (intention-to-treat) [ Time Frame: 6 months ]
    Difference between the diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true positives diagnosed by thoracoscopic biopsy in the two groups out of the total diseased

  2. Diagnostic sensitivity (per protocol) [ Time Frame: 6 months ]
    Diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true positives diagnosed by thoracocopic biopsy. In this analysis, the subjects crossed over to the rigid group (due to failure of minirigid to yield biopsy tissue) will be considered in the rigid group


Secondary Outcome Measures :
  1. Sedative and analgesic dose [ Time Frame: 1 day ]
    Comparing doses of sedative and analgesic agents required in the two groups

  2. Pain scores by visual analog scale [ Time Frame: 1 day ]
    Difference between intraoperative pain score associated with the use of the two devices (assessed after the procedure using the visual analog scale from 0-no pain to 100-maximum possible pain) in the two groups

  3. Diagnostic specificity [ Time Frame: 6 months ]
    Difference between the diagnostic specificity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true negatives diagnosed by thoracoscopic biopsy in the two groups out of those not diseased

  4. Safety [ Time Frame: 1 month ]
    Differences between number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in the two groups

  5. Scope maneuverability [ Time Frame: 1 day ]
    Differences between maneuverability of the two thoracoscopes on a visual analog scale (0-100 mm) assessed by the operator

  6. Ease of obtaining biopsy [ Time Frame: 1 day ]
    Differences between ease of obtaining pleural biopsy with the two thoracoscopes on a visual analog scale (0-100 mm) assessed by the operator

  7. Incision size [ Time Frame: 1 day ]
    Difference in the size of the incision required with the use of the two devices

  8. Procedure duration [ Time Frame: 1 day ]
    Difference in the duration of procedure in the two groups

  9. Pain scores by Wong Baker FACES pain rating scale [ Time Frame: 1 day ]
    Difference between intraoperative pain score associated with the use of the two devices (assessed after the procedure using the Wong Baker FACES pain rating scale) in the two groups



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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical thoracoscopy being performed for obtaining a pleural biopsy

Exclusion Criteria:

  • PaO2/FIO2< 300; Hemodynamic instability Myocardial infarction or unstable angina in the last 6 wk Lack of pleural space due to adhesions Uncorrected coagulopathy Failure to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449602


Contacts
Contact: Sahajal Dhooria, MD, DM +919530661388 sahajal@gmail.com
Contact: Ritesh Agarwal, MD, DM +919478402976 agarwal.ritesh@outlook.in

Locations
India
Postgraduate Institute of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Digambar Behera, MD    +911722756822    dirlrsi@gmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

Responsible Party: Sahajal Dhooria, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03449602     History of Changes
Other Study ID Numbers: NK/3695/Res
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sahajal Dhooria, Postgraduate Institute of Medical Education and Research:
thoracoscopy
pleuroscopy
metastatic cancer
lung cancer
malignant pleural effusion
tuberculosis

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases