Impact of Coronavirus Pandemic on The Practice of ERCP: A Multicenteric Study

INTRODUCTION

In December 2019, physicians from China reported clusters of pneumonia caused by a new coronavirus that could be isolated from infected patients [1]. An outbreak then began at the same time in Wuhan, China [2] the spread was rapidly escalating to which the World Health Organization declared a global pandemic on 11 March 2020. To date, the pandemic has spread across most countries in which the cumulative case number worldwide exceeding 46 million with 1.2 million reported deaths. The scale of the infection continues to expand and is unprecedented. Viral pneumonia affects about 200 million people every year, both children and adults [3]. Many respiratory viruses can cause severe form of pneumonia including coronavirus. The new corona virus, SARS-CoV 2 like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS-CoV) presented predominantly with respiratory symptoms [4,5] gastrointestinal manifestations were less reported in SARS-CoV 2 compared to other coronaviruses [6]. Human to human transmission can occur mainly via droplets and direct contact with presumed high rates of hospital-related transmission [7]. Healthcare workers are more prone to infection than general population reaching up to 20% of diagnosed cases in a report from Italy and even more in initial reports from the unites states [8,9]. Several health care authorities including different gastrointestinal societies released recommendations to ensure protection of nosocomial transmission of infection to both healthcare workers and patient’s [9,10]. Endoscopic procedures are now categorized as aerosol-generating procedures. Hence, healthcare workers (HCW) while performing endoscopic procedures are inevitably exposed to respiratory and GI secretions, therefore, adequate protection to HCW is important [9,11-13]. During COVID pandemic majority of the elective and non-urgent endoscopic procedures has been deferred, which has been broadly advocated by various societies. ERCP is an important therapeutic procedure that is required to address both elective as well as for several emergency causes such as biliary obstruction with cholangitis. However, this is also an aerosol-generating procedure, and these patients should also need to be managed with caution [14-16]. Also, there may be a grey area on the definition of what cases require an emergency or urgent ERCP according to a recent Survey [17]. The data to measure the impact of COVID-19 pandemic on ERCP performance is also limited [18]. The impact of different recommendations released by gastrointestinal societies needs to be continuously evaluated to confirm their effectiveness in preventing the spread of infection and to report its overall impact on service provided by different endoscopy unit. In this study, we aimed to explore the status of ERCP in different endoscopy units in different parts of the world, to report the characteristics of patients presented to these units and their procedure details.

PATIENTS AND METHODS

Retrospective observational study was conducted using data of ERCP patients between March and August 2020. The primary objectives of this study were to explore the change in performed ERCPs and to report patients and procedure characteristics inside gastrointestinal endoscopy units in response to COVID-19 in different countries. We used the below equation to calculate the sample size for assuming a confidence interval level of 95%:

 n = [DEFF*Np(1-p)]/ [(d²/Z²_1-α/2*(N-1)+p*(1-p)]  

Calculated Sample size: 257 patients were required.

Representatives of main endoscopy units in different countries were invited to participate. A detailed data sheet covering all aspects of ERCP inside gastrointestinal endoscopy units was developed to collect information regarding patient demographics, COVID-19 status through asking patients about symptoms of COVID-19 and history of recent contact with COVID-19 patients, ERCP indications, routine, or urgent status (cholangitis or biliary leak), laboratory findings, radiology findings, pre procedural preparation and post procedure complications. All procedure were done using infection control measures according to WHO guidelines. All responses were collected in an online platform (RedCap) and data were analyzed anonymously to reveal the effect of SARS-CoV-2 pandemic on different aspects of ERCP practice in the studied endoscopy units.

Statistical analysis:

We used the Statistical package for social science SPSS (Release 22.0, standard version, copyright ^© SPSS; 1989-02) to analyze the data. We performed a descriptive analysis and presented the results as mean ± standard deviation for quantitative variables and number (Percentage) for qualitative variables. Comparative analysis was done using independent t-test and Pearson’s Chi-square test where applicable. All p-values were two-sided and considered as statistically significant if  <0.05.

RESULTS

A total of 21 interventional gastrointestinal endoscopists participated in the study. They have collected data from 11 countries (Egypt, Brazil, Croatia, Philippines, Malaysia, Turkey, India, Morocco, Iran, USA and Pakistan) (Figure 1). Data of 352 patients were reported and analyzed. Average age of patients was 57.80 (SD ±16.88) years and 182 (51.7%) were females. Majority of patients were COVID-19 negative 332 (94.3%) whereas 2.8% were suspected cases and 0.9% were COVID-19 PCR positive, rest of baseline laboratory and radiological findings of the studied patients are described in Table 1. Patient with COVID-19 PCR positive was cured. The Approximately half (54%) of ERCPs were performed as an emergency procedure and 20.2% had previous ERCP done. Most centers reported a 50% decrease in staff number and duration of the procedure during COVID-19 in comparison to before COVID-19 practice. Most ERCP procedures were done by expert consultants and minority of the participating centers have involved trainees in ERCP procedures. The most common indications for ERCP were choledocholithiasis (51.7%) and suspected malignant biliary stricture (30.1%) rest of indications are presented in Table 2. Almost 68% of patients received antibiotics before ERCP. To PEP, only 85 (24.1%) received NSAIDs suppositories but half of them (55.1%) received hydration with ringer lactate or normal saline. Deep biliary cannulation was achieved in 324 (92%) cases mainly using conventional papillotomy over the guidewire (75.3%). However, freehand needle knife fistulotomy or sphincterotomy was used in 34 (9.7%) cases. Sphinceterotomy was performed in 255 (72.4%) cases which were limited Sphinceterotomy in 138 (54.1%) cases. Sphincteroplasty was performed in a few patients (11.9%) for 1±1.05 minutes. The average diameter of the balloon used for dilation was 13.5±2.3 mm. Occlusion cholangiogram was performed in 57.4% of cases. The most common therapeutic interventions carried out were CBD stone extraction using retrieval balloon in 160 (45.5%) of cases followed by plastic stent 158 (44.9%). Rest of ERCP procedure details and interventions are presented in Table 3. Biopsies were performed in 58 cases and revealed adenocarcinoma in 43 cases (74.13%). Cholangiocarcinoma was the diagnosis in 2 cases (3.44%) while 4 cases were suspected to be malignant (6.88%). Of note, no malignant cells were observed in 9 cases (15.5%). Complications were observed in 20 (5.6%) cases with bleeding being the most common immediate complication that was reported in 4.3% of patients. PEP was reported in 2.8% of cases and it was managed conservatively. Four patients (1.13%) had delayed post ERCP bleeding that was controlled with medical therapy and adrenaline injection. One patient (0.28%) with delayed post ERCP bleeding died after leaving the hospital against medical advice. Eight patients (2.3%) were referred to interventional radiology, 24 were referred for surgery (11.9%) and 18 patients (5.1%) were referred for endoscopic ultrasound for further management. The most common final diagnoses were choledocholithiasis (57.4%) and benign biliary strictures (10.8%) (Table 4).

Table 1: Laboratory and Radiological Findings of the Study Population (n=352)

SD, standard deviation; WBC, white blood cells; mg/dl, milligrams per deciliter; AST, aspartate aminotransferase; ALT, alanine aminotransferase; U/L, unit per liter; GGT, gamma-glutamyl transferase; INR, international normalized ratio; CEA, carcinoembryonic antigen; CA 19-9, carbohydrate antigen 19-9; AFP, alpha-fetoprotein; CT, computed tomography; MRCP,  magnetic resonance cholangiopancreatography; EUS, endoscopic ultrasound; CBD, common bile duct; IHBRD, intrahepatic biliary radicle dilation.

Table 2: Indication of ERCP During COVID-19 Pandemic.

ERCP, Endoscopic retrograde cholangiopancreatography; COVID-19, coronavirus disease 2019.

Table 3: ERCP Techniques Used and Interventions Performed.

ERCP, Endoscopic retrograde cholangiopancreatography; SD,  standard deviation; EUS, endoscopic ultrasound; CBD, common bile duct.

Table 4: Final Diagnosis for Patients Undergoing ERCPs During COVID-19 Pandemic

DISCUSSION