Pleural EffusionMICRONCT03449602
Minirigid Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions
A study testing Mini-thoracoscopy and Conventional rigid thoraoscopy in people with Pleural Effusion, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Mini-thoracoscopy and Conventional rigid thoraoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2018to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medical thoracoscopy being performed for obtaining a pleural biopsy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Postgraduate Institute of Medical Education and Research
Chandigarh, 160012
Digambar Behera, MD, +911722756822, dirlrsi@gmail.com
About this study
Official title: A Randomized Trial Comparing the Diagnostic Sensitivity and Safety of Mini-thoracoscopy Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions
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
Read the 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.
- Conditions
- Pleural Effusion
- Being tested
- Mini-thoracoscopy, Conventional rigid thoraoscopy
- Keywords
- thoracoscopy, pleuroscopy, metastatic cancer, lung cancer, malignant pleural effusion, tuberculosis
- Medical subject headings
- Pleural Effusion, Neoplasm Metastasis, Lung Neoplasms, Pleural Effusion, Malignant, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-thoracoscopyDevice
Thoracoscopic pleural biopsy with the mini-thoracoscope
Conventional rigid thoraoscopyDevice
Thoracoscopic pleural biopsy with the conventional rigid thoraoscope
| Study group | Role | What they receive |
|---|---|---|
| Mini-thoraoscopy | Experimental | 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. Receives: Device: Mini-thoracoscopy |
| Conventional rigid thoracoscopy | Active comparator | 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. Receives: Device: Conventional rigid thoraoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity (intention-to-treat)
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
Measured: 6 months
Diagnostic sensitivity (per protocol)
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
Measured: 6 months
Secondary outcomes (9)
Sedative and analgesic dose
Comparing doses of sedative and analgesic agents required in the two groups
Measured: 1 day
Pain scores by visual analog scale
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
Measured: 1 day
Diagnostic specificity
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
Measured: 6 months
Adverse effects
Differences between number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in the two groups
Measured: 1 month
Scope maneuverability
Differences between maneuverability of the two thoracoscopes on a visual analog scale (0-100 mm) assessed by the operator
Measured: 1 day
Ease of obtaining biopsy
Differences between ease of obtaining pleural biopsy with the two thoracoscopes on a visual analog scale (0-100 mm) assessed by the operator
Measured: 1 day
Incision size
Difference in the size of the incision required with the use of the two devices
Measured: 1 day
Procedure duration
Difference in the duration of procedure in the two groups
Measured: 1 day
Pain scores by Wong Baker FACES pain rating scale
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Mar 2018
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahajal Dhooria, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449602
- Sponsor's protocol ID
- NK/3695/Res
- Acronym
- MICRO
- Status last verified
- Mar 2023
- First submitted
- 17 Feb 2018
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing the Diagnostic Sensitivity and Safety of Mini-thoracoscopy Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions
- ClinicalTrials.gov ID
- NCT03449602
- Acronym / sponsor ID
- MICRO / NK/3695/Res
- Conditions
- Pleural Effusion
- Keywords
- thoracoscopy, pleuroscopy, metastatic cancer, lung cancer, malignant pleural effusion, tuberculosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-thoraoscopy | Experimental | Device: Mini-thoracoscopyThe 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. |
| Conventional rigid thoracoscopy | Active comparator | Device: Conventional rigid thoraoscopyThe 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. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical thoracoscopy being performed for obtaining a pleural biopsy
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-thoracoscopyThoracoscopic pleural biopsy with the mini-thoracoscope | Device | Mini-thoraoscopy |
| Conventional rigid thoraoscopyThoracoscopic pleural biopsy with the conventional rigid thoraoscope | Device | Conventional rigid thoracoscopy |
Primary outcome
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
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
9 secondary outcomes
Sedative and analgesic dose
Time frame: 1 day
Pain scores by visual analog scale
Time frame: 1 day
Diagnostic specificity
Time frame: 6 months
Adverse effects
Time frame: 1 month
Scope maneuverability
Time frame: 1 day
Ease of obtaining biopsy
Time frame: 1 day
Incision size
Time frame: 1 day
Procedure duration
Time frame: 1 day
Pain scores by Wong Baker FACES pain rating scale
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-thoracoscopy and Conventional rigid thoraoscopy in people with Pleural Effusion, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sahajal Dhooria, MD, DM (+919530661388, sahajal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity (intention-to-treat) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.