Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mini Thoracoscopy | Experimental | Thoracoscopy procedure shall be performed using the Rigid Mini Thoracoscope |
|
| Semirigid Thoracoscopy | Active Comparator | Thoracoscopy procedure shall be performed using the SemiRigid Thoracoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mini Thoracoscopy | Procedure | Pleural biopsy using rigid mini thoracoscope |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Yield | Proportion of diagnostic biopsies in the two arms | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation dose | Comparison of sedative and analgesic agent doses between the two groups | Through study completion, an average of 1 year |
| Complications | Complications related to the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of biopsy | Ease of obtaining pleural biopsy on visual analogue scale | Through study completion, an average of 1 year |
| Operator rated pain on scope manipulation | Operator rated pain on scope manipulation on Visual analogue scale (VAS) |
Inclusion Criteria:
Adequate rib spaces for successful performance of thoracoscopy as judged by clinical examination Adequate pleural fluid space as judged by pre-procedural USG chest
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Randeep Guleria, MD, DM | All India Institute of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | New Delhi | 110029 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SemiRigid Thoracoscopy |
| Procedure |
Pleural biopsy using semirigid thoracoscope |
|
| Through study completion, an average of 1 year |
| Procedural pain | Patient rated procedural pain on Visual Analogue Scale | Through study completion, an average of 1 year |
| Operator rated pain | Operator rated procedural pain on Visual Analogue Scale | Through study completion, an average of 1 year |
| Operator rated overall procedure satisfaction | Operator rated overall procedure satisfaction on Visual Analogue Scale | Through study completion, an average of 1 year |
| Biopsy Size | Mean size of biopsy obtained during pleural biopsy procedure | Through study completion, an average of 1 year |
| Alternate equipment | Requirement of conversion to alternate equipment for pleural biopsy | Through study completion, an average of 1 year |
| Image quality | Operator rated image quality of pleural visualization (VAS) | Through study completion, an average of 1 year |
| Through study completion, an average of 1 year |
| Expectation of diagnostic biopsy | Expectation that biopsy will be diagnostic on Visual Analogue Scale | Through study completion, an average of 1 year |
| Ease of manoeuvring thoracoscope | Ease of scope maneuvering on Visual Analogue Scale | Through study completion, an average of 1 year |