Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Immune System Diseases

Infections

Musculoskeletal Diseases

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Lung Neoplasms

Neoplasm Metastasis

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Pleural Effusion, Malignant

Pleural Effusion

Tuberculosis

Muscle Rigidity

Pleural Diseases

Respiratory Tract Diseases

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.

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.

Thoracoscopic pleural biopsy with the mini-thoracoscope

Mini-thoracoscopy

Thoracoscopic pleural biopsy with the conventional rigid thoraoscope

Conventional rigid thoraoscopy

Sahajal Dhooria, MD, DM

Ritesh Agarwal, MD, DM

Digambar Behera, MD

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

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.

Minirigid Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions

A Randomized Trial Comparing the Diagnostic Sensitivity and Safety of Mini-thoracoscopy Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions

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 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

Comparing doses of sedative and analgesic agents required in the two groups

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

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

Differences between number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in the two groups

Differences between maneuverability of the two thoracoscopes on a visual analog scale (0-100 mm) assessed by the operator

Differences between ease of obtaining pleural biopsy with the two thoracoscopes on a visual analog scale (0-100 mm) assessed by the operator

Difference in the size of the incision required with the use of the two devices

Difference in the duration of procedure in the two groups

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

Post Graduate Institute of Medical Education and Research, Chandigarh

Assistant Professor

Rare Diseases

Pleural Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Chronic Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Psychotropic Drugs

Anesthetics

Fentanyl

Dexmedetomidine

Midazolam

Dexmedetomidine infusion for pleuroscopy sedation. Rescue drugs will be midazolam for inadequate sedation and fentanyl for pain control

Midazolam for sedation and fentanyl for pain will be used for pleuroscopy monitored anesthesia care

The primary objective of this prospective trial will be to assess the effects of dexmedetomidine administration on oxygenation and respiratory function in patients undergoing diagnostic or therapeutic medical thoracoscopy/pleuroscopy for a pleural effusion compared to conventional conscious sedation/monitored anesthesia care (MAC) with midazolam. The secondary endpoint of the study will be to also assess the effects of dexmedetomidine administration on respiratory mechanics and postprocedural complications

The study will be conducted at the Department of Anesthesiology and Pain Management in collaboration with the Department of Thoracic Surgery at the Attikon University Hospital, Athens.

The trial has received approval by the Attikon University Hospital's Scientific \& Bioethics Committee and written informed consent will be obtained from all patients enrolled in the study.

Sample Size Calculation: A total of 60 patients will be assigned on a 1 to 1 basis to avoid bias to either a "DEX = dexmedetomidine" (n=30) or a "MIDAZOLAM/FENTANYL" group (n=30). To determine the required sample sizes quoted above, the statistical G-power calculator developed by Faul, Erdfelder, Lang, and Buchner was used. Values used to calculate the effect size (e=0.9326031) are based on results previously reported in the literature. For a study power of 90% with an alpha value of 0.05, a total of 26 patients in each group will need to be enrolled. Factoring in possible losses this number was rounded up to 30 patients per group.

Main Measurements Performance \& Methods: Patients will initially be assessed with spirometry and arterial blood gas (ABG) analysis prior to the medical thoracoscopy/pleuroscopy to determine their baseline values of Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC) and Partial arterial Pressure of Oxygen/ Fraction of Inspiratory Oxygen (PaO2/FiO2) ratio respectively. Intra-operatively repeat ABG analysis will be performed at 30 minutes following the start of administration of the study drug. Subsequent to their medical thoracoscopy/pleuroscopy procedure study subjects will remain in the Post Anesthesia Care Unit (PACU) for a minimum of 1 hour following the discontinuation of the study drug. Repeated ABG analysis and spirometry will be carried out at that 1 hour to assess improvement over the pre-operative values. The administration of the spirometry exam will be by the same pulmonologist using the same spirometer device so as to minimize inter-observer variability. Arterial blood gas measurements will also be performed in the same analysis device.

Protocol for Sedation \& Analgesia: Dexmedetomidine (DEX) group: Initial loading dose of dexmedetomidine will be 1.0 μg/kg of dexmedetomidine administered over 10 minutes. Fifteen minutes after starting the study drug administration, patients will be assessed for their level of sedation using the Observer's Assessment of Alertness/Sedation Scale (OAA/S), and any patient having a score ≥3 will receive intravenous (IV) midazolam in 0.5 mg doses, which will be repeated until the OAA/S is ≤2. MIDAZOLAM/FENTANYL group: Patients will be assessed for their level of sedation using the Observer's Assessment of Alertness/Sedation Scale (OAA/S), and any patient having a score ≥3 will receive intravenous (IV) midazolam in 0.5 mg doses, which will be repeated until the OAA/S is ≤2 All subjects will receive local anesthesia prior to the commencement of the "open" trocar insertion technique performed by the thoracic surgeon at the point of introduction of the rigid trocar in the pleural cavity with a combination of lidocaine 1.5% and ropivacaine 0.75%. If a patient is not adequately sedated, rescue midazolam will be administered as single IV boluses of 0.5 mg, which will be repeated as needed to achieve an OAA/S score of ≤3. Intravenous fentanyl, 25 μg boluses which can be repeated as necessary, will be given if a patient expresses a pain score of ≥3 during the study drugs infusion and ≥4 in the PACU on a Verbal scale of 0-10 (0 = no pain, 10 = worst pain), or if the anesthetist determines the presence of pain when verbal communication is not possible. Blood gas analysis will be obtained at 30' and 60' minutes intraoperatively. The dexmedetomidine infusion will be discontinued after wound closure.

At any time, if clinically indicated, the patient will be converted to an alternative sedative or anesthetic therapy and the study will be discontinued. OAA/S scores and all standard vital signs will be obtained every 5 min throughout the study drug infusion and before the administration of any rescue midazolam.

The time to reach OAA/S =5 from the end of infusion will be recorded. Other data recorded at the end of surgery will include total fentanyl and midazolam used intraoperatively, crystalloid infusion in litres, total mcg of the study drug (provided a \[dex\] = 4 mcg/ml) and postoperative Visual Analogue Scale (VAS) pain score. If VAS\>3 acetaminophen 1 g will be administered. The patient's monitoring will be continued in the post-anesthesia care unit (PACU) with vital signs been recorded every 5 minutes for the first 15 minutes, then every 15 minutes for the next 45 minutes. Blood gas analysis will be obtained every 30' until discharge from the PACU. At 24 hours from the end of surgery, a spirometry will be performed. Patient satisfaction and surgeon satisfaction score will also be registered (4-point scale - 0 min to 3 max). Patients will be discharged from the PACU when their OAA/S score =5.

Respiratory Function of Dexmedetomidine in Patients Undergoing Pleuroscopy

The Effect on Respiratory Function of Monitored Anesthesia Care With Dexmedetomidine in Patients Undergoing Diagnostic or Therapeutic Pleuroscopy

This 5 point Scale is used to assess level of sedation during the procedure (5- Responds readily to name spoken in normal tone, 4-Lethargic response to name spoken in normal tone, 3-Responds only after name is called loudly and/or repeatedly, 2-Responds only after mild prodding or shaking, 1-Does not respond to mild prodding or shaking)

incidence of bradycardia (HR \<45 beats/ min) during procedure

incidence of hypotension (MAP\<65 mmHg) during procedure

incidence of hypoxemia (SaO2\< 92%) during procedure

Attikon Hospital

Assistant Professor of Anesthesiology

Pleurisy

Communicable Diseases

Mycobacterium Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Respiratory Tract Infections

Four pleural biopsy specimens will be obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm) followed by 6-10 pleural biopsy specimens obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter).

Cryoprobe pleural biopsy first

Six to ten pleural biopsy specimens will be obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter) followed by four pleural biopsy specimens obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm)

Flexible forceps biopsy first

This is a prospective study to assess the yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy

Consecutive patients with exudative pleural effusions who are planned to undergo semirigid thoracoscopy will be enrolled in the study if they satisfy the inclusion criteria. They will be randomized in 1:1 ratio using a computer-generated randomization sequence to the following groups:

Group A: Four pleural biopsy specimens obtained using the flexible cryoprobe followed by eight pleural biopsy specimens obtained using the flexible thoracoscopic forceps OR Group B: The above two procedures will be performed in the reverse order The biopsies will be performed from different areas of the involved pleura with the two techniques. Thoracoscopy will be performed in the bronchoscopy suite on spontaneously breathing subjects (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.

Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy

A Study to Evaluate the Yield of Pleural Biopsy With a Flexible Cryoprobe Versus Flexible Forceps During Semirigid Thoracoscopy: a Comparative Study

The proportion of patients where a definitive histopathological diagnosis was obtained will be compared between the cryoprobe and flexible forceps biopsy

Size of biopsy specimens obtained with the two techniques

Time taken for the procedure with the two techniques

Ease of taking biopsy with the two techniques assessed using a visual analog scale

Number of patient speciemens with histopathologic artifacts with either technique including crush artefacts with the flexible forceps and freeze artifacts with the cryoprobe

Depth of the tissue obtained on histopathology

Number of participants with bleeding seen while taking biopsy categorised into "no bleeding", "minimal self limited ooze", "bleeding requiring prolonged suctioning" , "major hemorrhage requiring blood transfusion, causing hemodynamic instability or ICU admission"

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Minirigid Versus Conventional Rigid Thoracoscopy in Undiagnosed Pleural Effusions	NCT03449602	Pleural Effusio...	Mini-thoracosco... Conventional ri...	15 Years - 80 Years	PGIMER
Respiratory Function of Dexmedetomidine in Patients Undergoing Pleuroscopy	NCT03597828	Pleural Effusio... Pleural Effusio... Pleural Disease...		18 Years - 100 Years	Attikon Hospital
Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy	NCT02500277	Pleural Effusio... Pleurisy Tuberculosis Metastatic Mali...	Cryoprobe pleur... Flexible forcep...	12 Years - 79 Years	PGIMER

Spots Global Cancer Trial Database for pleuroscopy

Every month we try and update this database with for pleuroscopy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pleuroscopy

Every month we try and update this database with for pleuroscopy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pleuroscopy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.