Background: There is a lack of data on the prevalent practices of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in India. Aim: To study the current practices of ...EBUS-TBNA in India. Methods: This survey was an online questionnaire designed on the Google forms interface. The survey included various questions related to demographics, sedation, analgesia and anesthesia, technical aspects, and infection control related to the procedure of EBUS-TBNA. Results: Data from 134 respondents (mean age: 42.2 years) were analyzed. Most (97.8%) were pulmonologists or physicians, and a majority (94.8%) practicing in either a private multi-specialty setting or medical college. 40.3% had received procedure training at a formal training program. Mild/moderate sedation was the most common strategy (70.1%). Midazolam (76.7%), Fentanyl (76.0%), followed by propofol (46.5%), were the most frequent drugs, and 82.8% preferred combination sedation. 26.1% used cricothyroid lignocaine injection, and the use of 1% or 2% lignocaine for spray-as-you-go administration was similar. The oral route was preferred, while the laryngeal mask airway was the most common airway conduit under general anesthesia. Suspected granulomatous mediastinal lymphadenopathy (TB/sarcoidosis) (67.2%), followed by lung cancer (32.8%), were the most common indications of EBUS-TBNA. 81.3% performed EBUS-TBNA for lung cancer staging. 21 G needle was preferred (64.9%), and vacuum suction was common (80.6%). 55.2% routinely performed ROSE. Alcohol fixed glass slide smears were the most common method (93.1%) for cytological preparation. 49.3% also performed EUS-B-FNA. 76.9% routinely obtained endo bronchial biopsy and transbronchial lung biopsy in patients with suspected sarcoidosis. Elastography was infrequently used. Nearly three-fourths (77.6%) reused EBUS needles. Conclusion: There is practice variability in the multiple aspects related technical performance of EBUS-TBNA. Evidence-based guidelines addressing the multiple technical aspects are required to standardize the practice of EBUS-TBNA.
To assess the impact of adding statin (atorvastatin) and/or aspirin on clinical deterioration in patients infected with SARS-CoV-2 who require hospitalisation. The safety of these drugs in COVID-19 ...patients will also be evaluated.
This is a single-centre, prospective, four-arm parallel design, open-label, randomized control trial.
The study will be conducted at National Cancer Institute (NCI), Jhajjar, Haryana, which is a part of All India Institute of Medical Sciences (AIIMS), New Delhi, and has been converted into a dedicated COVID-19 management centre since the outbreak of the pandemic. All RT-PCR confirmed cases of SARS-CoV-2 infection with age ≥ 40 years and < 75 years requiring hospital admission (patients with WHO clinical improvement ordinal score 3 to 5) will be included in the trial. Written informed consent will be taken for all recruited patients. Patients with a critical illness (WHO clinical improvement ordinal score > 5), documented significant liver disease/dysfunction (aspartate transaminase AST / alanine aminotransferase ALT > 240), myopathy and rhabdomyolysis (creatine phosphokinase CPK > 5x normal), allergy or intolerance to statins or aspirin, prior statin or aspirin use within 30 days, history of active gastrointestinal bleeding in past three months, coagulopathy, thrombocytopenia (platelet count < 100000/ dl), pregnancy, active breastfeeding, or inability to take oral or nasogastric medications will be excluded. Patients refusing to give written consent and taking drugs that are known to have a significant drug interaction with statin or aspirin including cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor, telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole), clarithromycin and colchicine will also be excluded from the trial.
In this study, the benefit and safety of atorvastatin (statin) and/or aspirin as adjuvant therapy will be compared with the control group receiving usual care for management of COVID-19. Atorvastatin will be prescribed as 40 mg oral tablets once daily for ten days or until discharge, whichever is earlier. The dose of aspirin will be 75 mg once daily for ten days or until discharge, whichever is earlier. All other therapies will be administered according to the institute's COVID-19 treatment protocol and the treating physician's clinical judgment.
All study participants will be prospectively followed up for ten days or until hospital discharge, whichever is longer for outcomes. The primary outcome will be clinical deterioration characterized by progression to WHO clinical improvement ordinal score ≥ 6 (i.e., endotracheal intubation, non-invasive mechanical ventilation, pressor agents, renal replacement therapy, ECMO requirement, and mortality). The secondary outcomes will be change in serum inflammatory markers (C-reactive protein and Interleukin-6), Troponin I, and creatine phosphokinase (CPK) from time zero to 5th day of study enrolment or 7th day after symptom onset, whichever is later. Other clinical outcomes that will be assessed include progression to Acute Respiratory Distress Syndrome (ARDS), shock, ICU admission, length of ICU admission, length of hospital admission, and in-hospital mortality. Adverse drug effects like myalgia, myopathy, rhabdomyolysis, hepatotoxicity, and bleeding will also be examined in the trial to assess the safety of the interventions.
The study will use a four-arm parallel-group design. A computer-generated permuted block randomization with mixed block size will be used to randomize the participants in a 1:1:1:1 ratio to group A (atorvastatin with conventional therapy), group B (aspirin with conventional therapy), group C (aspirin + atorvastatin with conventional therapy), and group D (control; only conventional therapy).
The study will be an open-label trial.
As there is no existing study that has evaluated the role of aspirin and atorvastatin in COVID-19 patients, formal sample size calculation has not been done. Patients satisfying the inclusion and exclusion criteria will be recruited during six months of study period. Once the first 200 patients are included in each arm (i.e., total 800 patients), the final sample size calculation will be done on the basis of the interim analysis of the collected data.
The institutional ethical committee has approved the study protocol (Protocol version 3.0 June 2020). Participant recruitment starting date: 28
July 2020 Participant recruitment ending date: 27
January 2021 Trial duration: 6 months TRIAL REGISTRATION: The trial has been prospectively registered in Clinical Trial Registry - India (ICMR- NIMS): Reference no. CTRI/2020/07/026791 (registered on 25 July 2020).
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
Tuberculosis (TB) remains a major infectious disease across the globe. With increasing TB infections and a rise in multi-drug resistance, rapid diagnostic modalities are required to achieve TB ...control. Radiological investigations and microbiological tests (microscopic examination, cartridge-based nucleic acid amplification tests, and cultures) are most commonly used to diagnose TB. Histopathological/cytopathological examinations are also required for an accurate diagnosis in many patients.
The causative agent, Mycobacterium tuberculosis (Mtb), is known to circumvent the host's immune system. Circulating microRNAs (miRNAs) play a crucial role in biological pathways and can be used as a potential biomarker to detect tuberculosis. miRNAs are small non-coding RNAs and negatively regulate gene expression during post-transcriptional regulation. The differential expression of miRNAs in multiple clinical samples in tuberculosis patients may be helpful as potential disease biomarkers. This review summarizes the literature on miRNAs in various clinical samples as biomarkers for TB diagnosis.
Objectives: To analyze the safety and efficacy of bronchial artery embolization (BAE) in the management of hemoptysis. Methods: We conducted a retrospective study of 334 patients who had undergone ...BAE for hemoptysis from January 2007 to July 2013. Our study included 255 (76.3%) males and 79 (23.7%) females with an age range from five to 81 years old. All relevant arteries were evaluated but only those arteries that showed hypertrophy and significant blush were targeted. Polyvinyl alcohol (PVA) was used in all patients and gel foam was used in combination with PVA where there was significant shunting. Results: Mild hemoptysis was seen in 70 patients, moderate in 195 patients, and severe in 69 patients. On imaging, right side disease was seen in 101 patients, left side involvement in 59 patients, and bilateral involvement in 174 patients. Post-tubercular changes were the predominant pathology seen in 248 patients. Among 334 patients (386 procedures), 42 patients underwent the procedure twice and five patients underwent the procedure thrice. A total of 485 arteries were attempted of which 440 arteries were successfully embolized. Right intercosto-bronchial was the most common culprit artery present in 157 patients, followed by common bronchial (n=97), left bronchial (n=55), and right bronchial (n=45). We embolized a maximum of four arteries in one session. Immediate complications such as dissection and rupture occurred in only nine sessions (2.3%). Twenty-five procedures (6.5%) were repeated within two months, which were due to technical or clinical failure and 27 procedures (7%) were repeated after two months. Conclusions: BAE is a safe and effective procedure with a negligible complication rate. Our approach of targeting hypertrophied arteries was effective.
Coronavirus Disease 2019 (COVID-19) infection can have myriad presentations ranging from non specific constitutional symptoms to respiratory failure and extrapulmonary manifestations. As COVID-19 is ...viewed predominantly as an illness of the respiratory tract, extrapulmonary manifestations are often overlooked. The case series is of seven COVID-19 diagnosed patients who presented with diarrhoea, without respiratory symptoms. Clinicodemographic characteristics, hospital course and outcome of these patients are described here. Median age of the patients was 42 years. There were four males and three females. One patient had diabetes mellitus and hypertension, one had hypothyroidism and one had Hodgkin’s lymphoma along with tuberculosis. Five patients had fever while all had diarrhoea as the predominant presenting complaint. Median duration of symptoms was four days before admission. Laboratory abnormalities included anaemia (n=5; 57.1%), lymphopenia (n=3; 42.9%) and elevated inflammatory markers i.e., ferritin and C-reactive protein (n=2; 28.6%). Most patients did not require any specific treatment other than supportive care. All patients were successfully discharged after a median hospital stay of 10 days. Isolated diarrhoea without respiratory symptoms can be presenting complaint of COVID-19 and should be considered by clinicians in current pandemic scenario.
Medical thoracoscopy (MT) is a useful diagnostic and therapeutic procedure for a variety of pleural conditions. There is a lack of literature on prevalent practices of MT in India.
The objective of ...the study was to study the prevalent practices of MT in India.
A structured online survey on various aspects of thoracoscopy was designed on the "Google Forms" web software.
One hundred and eight responses were received, of which 100 respondents performed MT. The majority were pulmonologists, and most had started performing thoracoscopy within the last 5 years. Rigid thoracoscope was the most commonly used instrument. The common indications of procedure included undiagnosed pleural effusion, talc pleurodesis, and adhesiolysis. Local anesthesia with conscious sedation was the preferred anesthetic modality. Midazolam, along with fentanyl, was the most widely used sedation combination. 2% lignocaine was the most commonly used concentration for local infiltrative anesthesia. Nearly two-thirds of the respondents reported having encountered any complication of thoracoscopy. Significant reported complications included empyema, incision/port-site infection, re-expansion pulmonary edema, and procedure-related mortality.
MT is a rapidly evolving interventional pulmonology procedure in India. There is, however, a significant variation in practice and variable adherence to available international guidelines on thoracoscopy. Formal training programs within India and national guidelines for pleuroscopy considering the local resources are required to improve the safety and yield of this useful modality.
Ethambutol use may lead to permanent vision loss by inducing a dose- and duration-dependent optic neuropathy. This has been of concern to ophthalmologists and physicians both; however, ethambutol ...continues to be used because of its anti-mycobacterial action with relative systemic safety. Recently, the guidelines of the Revised National Tuberculosis Control Programme of India have been revised to allow for fixed dose and longer duration of ethambutol use; this is likely to result in an increase in vision-threatening adverse effects. Taking cognizance of this, neuro-ophthalmologists, infectious disease specialists, and scientists met under the aegis of the Indian Neuro-Ophthalmology Society to deliberate on prevention, early diagnosis, and management of ethambutol-related toxic optic neuropathy. The recommendations made by the expert group focus on early suspicion of ethambutol toxicity through screening at the physician's office and opportunistic screening by the ophthalmologist. Further, they focus on an early diagnosis through identification of specific clinical biomarkers and on management in way of early stoppage of the drug and supportive therapy. This statement also describes the mechanism of reporting a case of toxic optic neuropathy through the Pharmacovigilance Programme of India and emphasizes the need for spreading awareness regarding vision-threatening adverse effects among patients and healthcare workers.
Background: Chronic obstructive pulmonary disease (COPD) is an inflammatory disorder and has been proposed to have an imbalance between pro-inflammatory and anti-inflammatory factors. Methods: This ...study was conducted on 41 participants {18 COPD patients (smokers, COPD S (n = 9); reformed smokers, COPD RS (n = 9)) and 23 controls (non-smokers, CNS (n = 14); smokers, CS (n = 9))}. Flow cytometry was used to identify circulatory immune cells and correlated with serum cytokines. Results: On comparison, significantly lower frequency of CD3+ T cells were observed in COPD S as compared to CNS (p < 0.01) and CS (p < 0.01); CD4+ T cells were lower in COPD S (p < 0.05), COPD RS (p < 0.05) and CNS (p < 0.01) as compared to CS. CD8+ T cells were elevated in COPD S as compared to CS (p < 0.05). Lower frequency of cDCs were observed in COPD S as compared to CS (p < 0.05) and COPD RS as compared to CNS (p < 0.01) and CS (p < 0.01). Lower frequency of pDCs were observed in COPD RS as compared to COPD S (p < 0.05), CNS (p < 0.05) and CS (p < 0.01). Lower frequency of Tregs was observed in COPD S as compared to CNS (p < 0.05) and CS (p < 0.05). Conclusions: Characteristic changes observed indicate a significant impact of immune cells in the progression of the disease.
Introduction: Over the past few years, the demographic profile of lung cancer has changed. However, most reports are limited by small numbers, short follow-up period, and show an inconsistent ...pattern. A comprehensive evaluation of changing trends over a long period has not been done. Materials and Methods: Consecutive lung cancer patients were studied over a 10-year period from January 2008 to March 2018 at the All India Institute of Medical Sciences, New Delhi, and relevant clinical information, and survival outcomes were analyzed. Results: A total of 1862 patients were evaluated, with mean (SD) age of 59 (11.1) years, and comprising 82.9% males. Majority were smokers (76.2%) with median smoking index of 500 (interquartile range IQR: 300-800). Adenocarcinoma (ADC) was the most common type (34%), followed by squamous cell carcinoma (SCC - 28.6%) and small cell lung cancer (SCLC) (16.1%). Over the 10-year period, ADC increased from 9.5% to 35.9%, SCC from 25.4% to 30.6%, and non-small cell lung cancer -not otherwise specified (NSCLC-NOS) decreased from 49.2% to 21.4%. The proportion of females with lung cancer increased although smoking rates remained similar. Majority of NSCLC (95%) continued to be diagnosed at an advanced stage (3 or 4). Epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) rearrangements were present in 25.3% and 11.5% ADC patients, respectively. The median overall survival was 8.8 months (IQR 3.7-19) for all patients and 12.57 (IQR 6.2-28.7) months among the 1013 patients who were initiated on specific treatment (chemotherapy, targeted therapy, radiotherapy, or surgery). Never-smokers were younger, more likely to be female and educated, had a higher prevalence of ADC and EGFR/ALK mutations, and had better survival. Conclusion: Among this large cohort, our center seems to follow the global trend with increasing incidence of ADC. EGFR mutation positivity was similar to existing reports, while higher ALK positivity was detected. A characteristic phenotype of never-smokers with lung cancer was elucidated which demonstrated better survival.
Background: Thyroid transcription factor (TTF-1) is a diagnostic marker expressed in 75%–85% of primary lung adenocarcinomas (ACs). Activating mutations in the tyrosine kinase domain of the epidermal ...growth factor receptor (EGFR) gene is the most common targetable driver alteration in lung AC. Previous studies have shown a positive correlation between TTF-1 and EGFR mutation status. We aimed to determine the predictive value of TTF-1 immunoexpression for underlying EGFR mutation status in a large Indian cohort. Methods: This retrospective designed study was conducted with medical record data from 2011 to 2020. All cases of primary lung AC and non–small cell lung carcinoma not otherwise specified (NSCLC, NOS) with known TTF-1 expression diagnosed by immunohistochemistry using 8G7G3/1 antibodies and EGFR mutation status diagnosed by quantitative polymerase chain reaction were retrieved, reviewed, and theresults were analyzed. Results: Among 909 patient samples diagnosed as lung AC and NSCLC, NOS, TTF-1 was positive in 76.8% cases (698/909) and EGFR mutations were detected in 29.6% (269/909). A strong positive correlation was present between TTF-1 positivity and EGFR mutation status (odds ratio, 3.61; p < .001), with TTF-1 positivity showing high sensitivity (90%) and negative predictive value (87%) for EGFR mutation. TTF-1 immunoexpression did not show significant correlation with uncommon/dual EGFR mutations (odds ratio, 1.69; p = .098). EGFR–tyrosine kinase inhibitor therapy was significantly superior to chemotherapy among EGFR mutant cases irrespective of TTF-1 status; however, no significant differences among survival outcomes were observed. Conclusions: Our study confirms a strong positive correlation between TTF-1 expression and common EGFR mutations (exon 19 deletion and exon 21 L858R) in advanced lung AC with significantly high negative predictive value of TTF-1 for EGFR mutations.
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