Pleural EffusionMISTNCT02851927
Mini Thoracoscopy vs Semirigid Thoracoscopy in Exudative Pleural Effusions
A study testing Mini Thoracoscopy and SemiRigid Thoracoscopy in people with Pleural Effusion, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Mini Thoracoscopy and SemiRigid Thoracoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2016to Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rigid 'Mini-thoracoscopy' vs Semirigid Thoracoscopy in Undiagnosed Exudative Pleural Effusions : A Randomized Controlled Trial
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.
Read the detailed description
Patients meeting the inclusion criteria and giving prior consent for the study shall be randomised. The randomization sequence will be computer generated with variable block size and the assignments will be placed in opaque sealed envelopes. All patients will undergo hemogram, liver and renal function tests, coagulation profile, an electrocardiogram and Computed tomography (CT) of the chest before entering the study. Chest ultrasound will be performed in all patients to evaluate the rib spaces, amount of pleural fluid and for selection of the entry point.
Instruments The semi-rigid thoracoscope to be used is the autoclavable Olympus LTF-160 (Olympus, Tokyo, Japan) thoracoscope with 2.8 mm inner channel diameter and 7 mm outer diameter. The forceps is flexible forceps with alligator jaw with spike cusps, 2.8 mm of the outer diameter. The rigid mini thoracoscope is the Richard Wolf 5.5 mm operating endoscope with the working channel.
Thoracoscopy technique Thoracoscopy will be performed in the interventional pulmonology lab. Patients shall be fasting for solids for 8 hours and for liquids 6 hours. Patients shall be having continuous monitoring of blood pressure, pulse rate, and oxygen saturation.
Topical anesthesia will be achieved by infiltrating 2% lidocaine locally at the incision site. The procedure shall be performed under conscious sedation and analgesia using a combination of midazolam and intravenous fentanyl. An incision shall be made at the site of maximum fluid thickness as assessed by pre-procedural USG chest, with the patient in lateral decubitus position and involved side upward. After incision, the appropriately sized trocar shall be placed through the skin into the pleural space. The thoracoscope shall be inserted through the trocar. The pleural surfaces shall then be thoroughly inspected. A minimum of 6-8 pleural biopsy samples shall be obtained by semi-rigid thoracoscope and at least 4 with rigid mini-thoracoscope.
Samples shall be sent for histopathological analysis and mycobacterial cultures. At the end of the procedure, a chest tube shall be placed and removed subsequently.
All patients shall be followed up for a period of six months from the time of procedure if non-specific inflammation/ fibrinous pleuritis is the diagnosis or no definitive diagnosis is made during that time.
Statistical analysis:
Data shall be expressed as mean ± standard deviation (SD), or percentage. Differences in continuous variables between the two groups shall be compared using Student's t test (or Mann-Whitney U test); while differences in categorical data shall be compared using the chi-square test (or Fisher's exact test). A p value of less than 0.05 shall be considered statistically significant.
- Conditions
- Pleural Effusion
- Being tested
- Mini Thoracoscopy, SemiRigid Thoracoscopy
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini ThoracoscopyProcedure or surgery
Pleural biopsy using rigid mini thoracoscope
SemiRigid ThoracoscopyProcedure or surgery
Pleural biopsy using semirigid thoracoscope
| Study group | Role | What they receive |
|---|---|---|
| Mini Thoracoscopy | Experimental | Thoracoscopy procedure shall be performed using the Rigid Mini Thoracoscope Receives: Procedure: Mini Thoracoscopy |
| Semirigid Thoracoscopy | Active comparator | Thoracoscopy procedure shall be performed using the SemiRigid Thoracoscope Receives: Procedure: SemiRigid Thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield
Proportion of diagnostic biopsies in the two arms
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
Sedation dose
Comparison of sedative and analgesic agent doses between the two groups
Measured: Through study completion, an average of 1 year
Complications
Complications related to the procedure
Measured: Through study completion, an average of 1 year
Procedural pain
Patient rated procedural pain on Visual Analogue Scale
Measured: Through study completion, an average of 1 year
Operator rated pain
Operator rated procedural pain on Visual Analogue Scale
Measured: Through study completion, an average of 1 year
Operator rated overall procedure satisfaction
Operator rated overall procedure satisfaction on Visual Analogue Scale
Measured: Through study completion, an average of 1 year
Biopsy Size
Mean size of biopsy obtained during pleural biopsy procedure
Measured: Through study completion, an average of 1 year
Alternate equipment
Requirement of conversion to alternate equipment for pleural biopsy
Measured: Through study completion, an average of 1 year
Image quality
Operator rated image quality of pleural visualization (VAS)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2018
- Study completionSep 2018
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karan Madan, All India Institute of Medical Sciences
- Investigators
- Randeep Guleria, MD, DM, Study chair, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851927
- Sponsor's protocol ID
- Mini vs Semirigid RCT
- Acronym
- MIST
- Status last verified
- Dec 2018
- First submitted
- 1 May 2016
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rigid 'Mini-thoracoscopy' vs Semirigid Thoracoscopy in Undiagnosed Exudative Pleural Effusions : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02851927
- Acronym / sponsor ID
- MIST / Mini vs Semirigid RCT
- Conditions
- Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 2 Aug 2016 (estimated)
- 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.
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.
Detailed description
Patients meeting the inclusion criteria and giving prior consent for the study shall be randomised. The randomization sequence will be computer generated with variable block size and the assignments will be placed in opaque sealed envelopes. All patients will undergo hemogram, liver and renal function tests, coagulation profile, an electrocardiogram and Computed tomography (CT) of the chest before entering the study. Chest ultrasound will be performed in all patients to evaluate the rib spaces, amount of pleural fluid and for selection of the entry point.
Instruments The semi-rigid thoracoscope to be used is the autoclavable Olympus LTF-160 (Olympus, Tokyo, Japan) thoracoscope with 2.8 mm inner channel diameter and 7 mm outer diameter. The forceps is flexible forceps with alligator jaw with spike cusps, 2.8 mm of the outer diameter. The rigid mini thoracoscope is the Richard Wolf 5.5 mm operating endoscope with the working channel.
Thoracoscopy technique Thoracoscopy will be performed in the interventional pulmonology lab. Patients shall be fasting for solids for 8 hours and for liquids 6 hours. Patients shall be having continuous monitoring of blood pressure, pulse rate, and oxygen saturation.
Topical anesthesia will be achieved by infiltrating 2% lidocaine locally at the incision site. The procedure shall be performed under conscious sedation and analgesia using a combination of midazolam and intravenous fentanyl. An incision shall be made at the site of maximum fluid thickness as assessed by pre-procedural USG chest, with the patient in lateral decubitus position and involved side upward. After incision, the appropriately sized trocar shall be placed through the skin into the pleural space. The thoracoscope shall be inserted through the trocar. The pleural surfaces shall then be thoroughly inspected. A minimum of 6-8 pleural biopsy samples shall be obtained by semi-rigid thoracoscope and at least 4 with rigid mini-thoracoscope.
Samples shall be sent for histopathological analysis and mycobacterial cultures. At the end of the procedure, a chest tube shall be placed and removed subsequently.
All patients shall be followed up for a period of six months from the time of procedure if non-specific inflammation/ fibrinous pleuritis is the diagnosis or no definitive diagnosis is made during that time.
Statistical analysis:
Data shall be expressed as mean ± standard deviation (SD), or percentage. Differences in continuous variables between the two groups shall be compared using Student's t test (or Mann-Whitney U test); while differences in categorical data shall be compared using the chi-square test (or Fisher's exact test). A p value of less than 0.05 shall be considered statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini Thoracoscopy | Experimental | Procedure: Mini ThoracoscopyThoracoscopy procedure shall be performed using the Rigid Mini Thoracoscope |
| Semirigid Thoracoscopy | Active comparator | Procedure: SemiRigid ThoracoscopyThoracoscopy procedure shall be performed using the SemiRigid Thoracoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
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 ThoracoscopyPleural biopsy using rigid mini thoracoscope | Procedure or surgery | Mini Thoracoscopy |
| SemiRigid ThoracoscopyPleural biopsy using semirigid thoracoscope | Procedure or surgery | Semirigid Thoracoscopy |
Primary outcome
Diagnostic Yield
Time frame: Through study completion, an average of 1 year
Proportion of diagnostic biopsies in the two arms
8 secondary outcomes
Sedation dose
Time frame: Through study completion, an average of 1 year
Complications
Time frame: Through study completion, an average of 1 year
Procedural pain
Time frame: Through study completion, an average of 1 year
Operator rated pain
Time frame: Through study completion, an average of 1 year
Operator rated overall procedure satisfaction
Time frame: Through study completion, an average of 1 year
Biopsy Size
Time frame: Through study completion, an average of 1 year
Alternate equipment
Time frame: Through study completion, an average of 1 year
Image quality
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Pleural Effusion
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
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.
Randeep Guleria, MD, DM study chair
All India Institute of Medical Sciences
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 SemiRigid Thoracoscopy in people with Pleural Effusion, run by All India Institute of Medical Sciences 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 27 Dec 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield (time frame: Through study completion, an average of 1 year). 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 27 Dec 2018.