Endoscopic Ultrasound at Crossroads in COVID - 19 era:‎ a Multi-Center Global Study.

INTRODUCTION

Coronavirus disease 2019 (COVID -19) emanated in China in late 2019 and soon became rapidly progressive pandemic. Covid-19 crisis is an overwhelming challenge affecting world and has forced nations to make hard choices on how to respond. Brutality of Covid-19 pandemic forced centers to double down their efforts on patient care and safety [1,2].Scientifically robust and ethically sound clinical research has finally led to availability of vaccines against COVID -19, but real-time decision-making implementation is paramount for navigating vaccination challenges especially in time and resource constraint setting.

Aerosol generating nature of gastrointestinal (GI) endoscopy has made it high risk procedure for COVID-19 transmissions. Endoscopy personnel are at risk of transmission during various exposures from person-to-person via direct or prolonged contact and also exposure to infected aerosols or droplets generated during endoscopic procedures that are likely to trigger cough and retching during the procedure. Besides that, handling of contaminated endoscopic equipment, accessories and body fluids also increases the risk of exposure [3,4]. However, transmission of virus to uninfected patients via contaminated endoscopes has not been reported so far under the circumstances where the current disinfection and reprocessing guidelines that has been advocated by American Society for Gastrointestinal Endoscopy and European Society of Gastrointestinal Endoscopy have been practiced strictly [5-7].

Endoscopic ultrasound (EUS) is an important diagnostic and therapeutic procedure that is required for several critical and emergent causes such as biliary drainage, gallstone pancreatitis, EUS guided drainage of walled off pancreatic necrosis, symptomatic pancreatic pseudocysts, management of bleeding gastric varices with coils, histological diagnosis for cancers and gallbladder in acute cholecystitis in a surgically unfit patient [4,8,9]. Furthermore, EUS procedures are thought to generate more droplets due to its larger diameter of the endoscopes leading to higher possibility of cough, increased used of accessories for interventions, relatively longer procedural time, and more leakage of body fluids like GI secretions and bile through the working channel during procedures [10,11].

Responsible stewardship is need of hour for safely restarting GI endoscopy in the era of COVID-19. There is limited information about how the pandemic has influenced EUS performance so far [12,13].The impact of different recommendations released by GI societies needs to be continuously evaluated to confirm their effectiveness in preventing spread of infection and to report its overall impact on services provided by different endoscopy unit. This survey is designed to provide a rapid and robust assessment of status of EUS during COVID-19 pandemic in different leading units of the world, and also to elucidate patient and procedure characteristics during this period.

METHODS

Study Design and Oversight: the primary objectives of this study were to measure the percentage change in performed EUS inside GI endoscopy units in response to COVID-19 in different countries. The study was conducted as a survey in June 2020. Senior endoscopists (who were directly involved in doing EUS) representing high throughput endoscopy units in different countries were invited by email to complete questionnaire.  The structured questionnaire was available on the Redcap platform (Supplementary material) covering all aspects regarding COVID-19–related changes in endoscopic activities, demographics, COVID-19 status, EUS indications,  routine or urgent status, laboratory findings, radiology findings, procedural details, endoscopic findings, other procedures, and post procedure  complications. Participation was voluntary and no incentive was offered for participation.

Data Collection and Analysis: All responses were collected in the online platform and transferred to SPSS version 24(IBM SPSS Inc, Chicago, IL) for analysis. Descriptive analysis was done by calculating percentages for categorical variables and mean± standard deviation for quantitative variables. Comparative analysis was done by using the chi-square test or the Student t test where appropriate. All differences were considered significant at a 2-sided P value of <.05.

RESULTS

A total of 45 high volume endoscopy units from different parts of world participated and 316 patients were enlisted during the period of study (Table 1).

Demographic, clinical and laboratory characteristics of study population:

The mean (± SD) age of the patients in this study was 55.57±13.94 years and 42.7 % were females. A history of smoking was present in 14.6% of the patients and about 4 % were alcoholics. In this analysis 62.3% were lab confirmed SARS-Cov-2 negative while 8 patients were suspected and only 1 patient was lab confirmed positive for COVID -19 (Table 2).  The remaining patients (34.8 %) were presumed SARS-Cov-2 negative (on basis of clinical and radiological features) though PCR confirmation was not available. 

Daily performance of EUS was similar in before and during COVID-19 pandemic with an insignificant decrease of -1.1% Emergent and urgent EUS was needed in 58 (14.4%) and 91 (28.8%) patients respectively. Half of procedures done were routine. Few patients (6.6 %) had history of previous EUS. About half of patients didn’t receive antibiotic and most patient didn’t receive any NSAIDS either prior to or after procedure. Almost half of the patients s (n=164, 51.9 %) underwent CT prior to EUS. The median AST, ALT and Alkaline phosphatase were 80, 97 and 295 IU/L.

Indications of EUS:

Pancreatic mass (27.8%), biliary dilatation (10.4%) and pancreatic cyst (7.3%) formed major chunk of indications for procedure. Other important indications were possible subepithelial lesion, luminal GI cancer staging, pancreatic duct dilation, evaluation for CBD stones, abdominal/mediastinal lymphadenopathy and abdominal pain. Fifty-five patients (17.4%) were referred to EUS after ERCP (Table 3).

Final diagnosis, outcomes and complications of EUS:

Most patients (93.4%) underwent examination by linear EUS with only 1 patient needing both linear and radial EUS. Complete detailed examination was done in almost all patients (n = 314, 99.4 %) (Table 4).

Therapeutic outcomes were achieved with majority (40.8%) undergoing fine needle aspiration/ biopsy (FNA / FNB). Seven patients needed celiac plexus block/ neurolysis, while 4 patients underwent EUS guided coil and cyanoacrylate injection. Few of them needed pseudocyst drainage.  Few of these patients (17.4%) were referred for surgery and 2 patients needed interventional radiology procedures.

Table (1): Number of procedures per country.

Table (2): Demographic, clinical and laboratory characteristics of study population (n=316).

IHBR; Intrahepatic biliary radical, CBD; Common bile duct, NSAID; Non-steroidal anti-inflammatory drugs

Table (3): Indication of EUS.

Table (4): Final diagnosis, outcomes and complications of EUS (n=316).

* No adverse events were reported.

DISCUSSION