key: cord-340857-teq5txm9
authors: Galloro, Giuseppe; Pisani, Antonio; Zagari, Rocco Maurizio; Lamazza, Antonietta; Cengia, Gianpaolo; Ciliberto, Enrico; Conigliaro, Rita L.; Carrara, Paola Da Massa; Germanà, Bastianello; Pasquale, Luigi
title: SAFETY IN DIGESTIVE ENDOSCOPY PROCEDURES IN THE COVID ERA RECOMMENDATIONS IN PROGRES OF THE ITALIAN SOCIETY OF DIGESTIVE ENDOSCOPY
date: 2020-05-13
journal: Dig Liver Dis
DOI: 10.1016/j.dld.2020.05.002
sha: 
doc_id: 340857
cord_uid: teq5txm9

The new corona virus disease has started in Wuhan - China at the end of 2019 and quickly spread with a pandemic trend across the rest of the world. The scientific community is making an extraordinary effort to study and control the situation, but the results are just partial. Based on the most recent scientific literature and strong statements by the most prestigious international health institutions, the Italian Society of Digestive Endoscopy has drawn up some recommendations about the use of personal protective equipment, the correct way of dressing and undressing of endoscopists and nurses, before and after digestive endoscopy procedures. In addition, some other important indications are given to reduce the risk of contamination of healthcare providers during endoscopic activities, in the setting of a pandemic. Nevertheless, because of the very quick evolution of our knowledge on this issue, these recommendations must be considered as evolving, because they could change in a short time.

The new corona virus disease has started in Wuhan -China at the end of 2019 and quickly spread with a pandemic trend across the rest of the world. The scientific community is making an extraordinary effort to study and control the situation, but the results are just partial. Nevertheless, because of the very quick evolution of our knowledge on this issue, these recommendations must be considered as evolving, because they could change in a short time. 

The new coronavirus disease, so-called CoViD-19, started in Wuhan -China at the end of 2019 and quickly spread with a pandemic trend across the rest of the world (1) . The international scientific community is making its best effort to contain the problem; however, because of the scarcity of available information the effectiveness of these efforts suffers a measure of uncertainty. Moreover, the problem of undocumented infectious patients (with mild, limited or no symptoms) makes it exceedingly difficult to define univocal pathways (2) .

As a consequence, at present, we should follow two lines of conduct: on one hand, we have to consider our new knowledge as temporary, subject to change in a short time; on the other hand, exactly for this reason, we have to act carefully to avoid further spread of the disease by inappropriate procedures.

In this paper, aimed at endoscopists, gastroenterologists, surgeons, and nurses we 

The corona viruses are an important group of large, enveloped, positive-single-stranded RNA viruses causing a wide spectrum of diseases in animals and humans (3, 4) . In 2002 and 2012 two different types of corona viruses where isolated, causing respectively severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) (5, 6) . At the end of December 2019, a novel type of corona virus has been isolated as responsible of a new syndrome named corona virus disease 2019 (CoViD-19) by the WHO (7) and severe acute respiratory syndrome by corona virus 2 (SARS-CoV-2) by the International Committee on Taxonomy of Viruses (8) .

This virus, suspected to have a zoonotic origin (9, 10) , uses a densely glycosylated spike protein to enter the host cells and binds with high affinity to the angiotensin-converting enzyme 2 (ACE2) receptor in humans in a similar way to SARS-CoV1 (11) .

Chinese data suggest that the mean age of the infected patients is around 53 years, with a predominance of male subjects (8, 12) . In spite of these data, there are papers reporting no difference in the proportion of male and female subjects admitted to hospital. A possible explanation could be that the first reports of new corona virus infection were correlated to the hospitalization of a high number of workers of the Huanan Seafood Wholesale Market, most of whom were male (13) .

The median incubation time of the disease is about 4-6 days, ranging from 1 to 15 days (8, 14) .

In clinical practice, most of the patients affected by CoViD-19 present with respiratory symptoms (dry cough, sputum production, sore throat, shortness of breath, dyspnea) with or without fever (40% on admission and about 85% during hospitalization), fatigue, and myalgia, sometimes presenting nasal and conjunctival congestion too (2, (15) (16) (17) (18) (19) .

At current time, there is some uncertainty about the prevalence of extra-respiratory manifestations, such as those concerning the digestive tract. Some Authors define digestive symptoms as nausea, vomiting, diarrhea (often observed as first manifestation in young patients), anorexia, abdominal pain as uncommon (13, 20, 21) but many others indicate that they are quite common. In many case-series, up to 50% of clinical manifestations started with digestive and not necessarily with respiratory symptoms, which developed later, during the hospital stay (19, (22) (23) (24) (25) .

In a recent Chinese study, an important risk hypothesis was presented. It seems that patients initially presenting digestive symptoms could have a longer interval from onset to admission and a worse prognosis, as compared to patients presenting with respiratory symptoms. This could be because if doctors rely only on pulmonary signs to raise the suspicion of CoViD-19, they may miss some cases showing, initially, only digestive symptoms. This could delay the diagnosis of the syndrome until the respiratory symptoms appear at an advanced stage (26) . However, at the moment, the evidence supporting this hypothesis is limited; therefore, further and more detailed investigations are needed before this information is taken for granted.

Early identification of suspected subjects represents the first step to prevent and contain the spread of the disease (27, 28) . In this perspective, it is especially important to stratify the patients using some risk indicators about the possibility of disease transmission. According to different studies, we must consider the following elements as risk indicators: 1) respiratory symptoms (dry cough, sputum production, sore throat, shortness of breath, dyspnea, acute respiratory infection of any severity) with or without fever;

2) clinical and/or radiological diagnosis of pneumonia;

3) digestive symptoms (nausea, vomiting, diarrhea, anorexia, abdominal pain); 4) fever > 37.5°C (even if without pulmonary involvement); 

The possible ways of corona virus transmission in health workers are several and comprise (11, 26, 30) :

-person-to-person, by respiratory secretions, salivary droplets; -aerosol generated by medical procedures; -contact with body fluids; -contact with contaminated surroundings.

In addition the CDC and some other Authors detected the virus in the feces of CoViD-19 positive patients (in up to 54% of the cases), suggesting a potential fecal-oral transmission (31, 32) . The virus has been isolated in the blood of infected subjects too, thus it is recommended to be very careful in the handling of blood samples and bioptic specimens (11, (33) (34) (35) (36) . Moreover, corona virus has been isolated in urine: as a consequence, this potential way of transmission needs to be investigated (37) .

Person-to-person contamination, by respiratory secretions, salivary droplets, and aerosol, linear decrease in the log 10 TCID 50 per liter of air over time (38) . Based on these data and considering that all endoscopic procedures are aerosol-generating and performed in close and prolonged contact with the patient, digestive endoscopy must be considered as a discipline with a very high risk of contagion (24) (25) (26) 30) . Cough, retching, and vomiting which can generate aerosols as well as flatus, occurring during colonoscopy, disseminate germs to the surroundings (39) .

Besides, the half-life, stability, and decay of corona virus has been studied on different materials such as plastic, stainless steel, copper, and cardboard that can be present in several surfaces of the endoscopy room. The virus seems to be more stable on plastic and stainless steel surfaces, with viable particles up to 72 hours after application to these materials, compared to copper and cardboard. Nevertheless, the virus titer was greatly reduced after 72 hours on plastic (from 10 3.7 to 10 0.6 TCID 50 per milliliter of medium) and

after 48 hours on stainless steel (from 10 3.7 to 10 0.6 TCID 50 per milliliter of medium). No viable virus particles were measured on copper, after 4 hours, and on cardboard after 24

hours. The half-life of corona virus is longest on stainless steel and plastic, compared to that on copper and cardboard; its estimated median half-life is approximately 5.6 hours on stainless steel and 6.8 hours on plastic. The virus has an exponential decay in titer, as indicated by a linear decrease in the log 10 TCID 50 per milliliter of medium over time (38) . (30, (40) (41) (42) (43) .

The first TIMES magazine cover of April 2020 is dedicated to the healthcare workers called heroes of the front-line, many of whom died facing the CoViD-19 during their hospital shifts. Many thousands of doctors and nurses, all over the world, have died of COVID 19 infection, often because of the lack of the right PPEs or for having used them

incorrectly. This, in the height of the third millennium, is frustrating and totally unacceptable.

As we mentioned above, all endoscopic procedures must be considered as activities at very high-risk of infection because of the prolonged and close contact with the patients, their salivary droplets and body fluids, and of the generation of aerosols (30, 39, 41, 43) . On the other hand, in addition to the contagion risk for endoscopists and nurses, the problem of asymptomatic patients must always be kept in mind. Indeed, some patients show a wide range of symptoms, but others have minimal symptoms or are completely asymptomatic (17, 18, 25, 44) . Moreover, the spread of the virus can occur from both symptomatic and asymptomatic patients, with the same severity (26, 28, 37, 45) . These asymptomatic but infectious subjects represent a huge source of contagion, and for this reason some

Authors named them as super-spreaders. For all these reasons, the potential infection risk of healthcare workers in performing endoscopic activities, even in case of negative or nonsuspect patients, should never be underestimated and all appropriate PPEs must be correctly used.

A recent ad-interim guidance, about the preventive measures of infection control (shown in   table 3 ) and about the right use of appropriate PPE for healthcare workers performing endoscopy on subjects with CoViD-19, has been published by the WHO (45) . On the same topic, SIED has published a video-tutorial for endoscopists and nurses about the use of PPE in the endoscopy room and the correct way of dressing and undressing (46) .

Preliminary recommendations are shown in table 4.

Before starting the dressing procedure, it is necessary to make sure that the needed material is arranged in order of use as indicated in the internal protocols and check lists.

Dressing must be carried out with the help of a mirror or, better, under the supervision of a trained observer who follows the appropriate check list and reads aloud each phase of the procedure, to ensure maximum adherence to the same.

Since digestive endoscopy procedures are at high risk of contagion (due to close and continuous contact with the patient who produces droplets and / or aerosols of secretions), the following PPE must be placed on a trolley, in order of use: 7. a second pair of surgical long gloves.

The WHO recommends the use of an apron, although this device is not usually used in many countries (44) . Dressing recommendations are shown in table 5.

Even undressing must be carried out with the help of a mirror or, better, under the supervision of a trained observer who verifies that the PPE has been removed correctly. If there is no filter area in the endoscopy room, the undressing must begin inside the room in which a division between a dirty and a clean zone must be prepared and, finally, completed outside the room. Undressing recommendations are showed in table 6.

The topic of protective mask is an extremely hot one. Surgical masks are designed to block large particles and they are ineffective in blocking small aerosol particles (< 5 µm) to reduce the risk of CoViD-19 contagion (42) . Because of the global PPE shortage their use must be rationalized, minimizing the waste and reserving them for the appropriate cases (45) .

How to organize the staff workstations and workflow?

Before starting work, daily, all staff members must measure their temperature. In case of fever, the subject must not be allowed to work and must be tested for CoViD-19 infection.

To prevent the spreading of infection among the staff, it is important to organize the work at individual working stations using dedicated phones, computers, and chairs staying at 2 meters' minimum distance from one another. Avoid sharing the same equipment. Wipe and disinfect the workstations before and after use with virucide, following the decontamination protocols (30) .

Provide the staff with a clear job description and, eventually, backup plans. To minimize cross infections, separate the workforce into two teams: the first one is on-site, providing direct clinical care; the second one is off-site, programing clinical care. This way will make it possible to minimize the risk of contagion and provide substitution if a member of the staff falls ill or needs quarantine (30) .

How to organize the Endoscopy Unit spaces?

Set up a reception area to asses and stratify the patients' risk of CoV-19 infection before allowing them to enter the waiting room with other persons. They must be separated two meters from one another.

A designated room for suspected and positive CoViD-19 patients, fitted adhering to all biosafety requirements, must be set up.

Set up a designated area for PPE dressing, near the endoscopy room. PPE undressing ideally occurs in an anteroom or a dedicated area, separated from the endoscopy rooms (43) .

In the staff relax/eating room, the persons will be separated by two meters from one another, sitting in the same direction, by preventing face-to-face infection transmission (30) .

The bathroom is a potential site of transmission. For this reason, patient and staff bathrooms must be separated and frequently disinfected (30) .

Which patients must undergo endoscopy?

In outbreak time, particularly in red zones, it is mandatory to limit the indications for endoscopic procedure to emergencies (acute digestive bleeding, foreign bodies extraction, and acute suppurative cholangitis) and cancers care. All non-urgent cases must be rescheduled. This is aimed at reducing the risk of spreading infection from asymptomatic patients, the risk of patients-to-patients and patients-to-healthcare workers cross-infection, the use and costs of PPE, and unnecessary admissions to free up hospital resources (22, 25, 30) .

Are negative pressure rooms really necessary?

The virus characteristics and the ways in which it is transmitted make digestive endoscopy a perfect route for infection (29, 49) . Moreover, the potential infection spreading from asymptomatic subjects amplifies the need to apply whatever behavior and protocol is suitable to prevent infection in healthcare workers (33, (49) (50) (51) . In details, the power of CoVi-19

to remain viable for several hours on different materials (37, 39) and the aerosol generation suggest that endoscopic procedures (37) (38) (39) (40) may contribute to the nosocomial transmission of CoViD-19. Thus, the use of negative pressure rooms with anterooms may reduce the spread of the infection in the hospitals (43) . Accordingly, on this point, the AGA institute says: "in health care workers performing any GI procedure, with known or presumptive CoViD-19, the AGA suggests the use of negative pressure rooms over regular endoscopy rooms, when available (Conditional recommendation, very low level of evidence)" (43) .

Thus, the use of negative pressure rooms is strongly suggested to perform endoscopic procedures in suspected and positive CoViD-19 patients. When negative pressure rooms are unavailable, portable industrial-grade high-efficiency particulate air (HEPA) filters may be a reasonable alternative, according to CDC suggestions (52, 53) .

What do we have to do before endoscopic procedures?

For out-patients:

1. provide all patients with mask during triage and waiting for the procedures;

2. screen and assess the risk of patients (clinical evaluation of symptoms, recent contact and travel history);

3. test the suspected patients and, if possible, wait for the test result before the procedure.

For in-patients:

tables, and walls of the examination room. Chlorine-containing detergent is recommended for daily floor cleaning (59) (60) (61) . 

All the Authors declare that they have no conflict of interest.

The Authors thank Orazio Labianca MD and Saverio Siciliano MD, for support and technical assistance in the preparation of the manuscript, and Daniela Cicatiello, for proofreading service. contribute to the breakage of gloves and could remain contaminated even after washing hands 6. Always work with a hospital disposable water-repellent uniform and plastic clogs, so they can be disposed/disinfected once the care activity is completed 

Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV2)

World Health Organization: Corona-virus disease (COVID-19) outbreak

Enteric involvement of severe acute respiratory syndrome-associated coronavirus infection

Coronavirus pathogenesis

Therapeutic options for middle east respiratory syndrome coronavirus (MERS-CoV) infection: how close are we?

Perspectives on monoclonal antibody therapy as potential therapeutic intervention for Coronavirus disease-19 (COVID-19)

World Health Organization: Pneumonia of Unknown Cause -China

World Health Organization: Coronavirus disease (COVID-2019) situation reports

A new coronavirus associated with human respiratory disease in China

COVID-19 New Insights on a Rapidly Changing Epidemic

Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72.314 cases from the Chinese Center for Disease Control and Prevention

Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus infected pneumonia in Wuhan, China. JAMA2020 Feb 7

A novel coronavirus outbreak of global health concer

for the China Medical Treatment Expert Group for Covid-19: Clinical Characteristics of Coronavirus Disease 2019 in China

Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study

Transmission of 2019-nCoV infection from an asymptomatic contact in Germany

Feng Z: Early transmission dynamics in

Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study

Enteric involvement of severe acute respiratory syndrome-associated coronavirus infection

Hospital outbreak of Middle East respiratory syndrome coronavirus

novel coronavirus infection and gastrointestinal tract

A new coronavirus associated with human respiratory disease in China

Evidence for gastrointestinal infection of SARS-CoV-2

Suggestions for infection prevention and control in digestive endoscopy during current 2019-nCoV pneumonia outbreak in Wuhan

Clinical characteristics of COVID-19 patients with digestive symptoms in Hubei, China: a descriptive, cross-sectional, multicenter study

Epidemiologic study and containment of a nosocomial outbreak of severe acute respiratory syndrome in a medical center

Epub ahead of print). 29. Ministero della Salute: CoViD-19: aggiornamento della definizione di caso

Considerations in performing endoscopy during the COVID-19 pandemic

Center for Disease Control and Prevention: 10 Things you can do to manage COVID-19 at home. CDC; 2020

Gastrointestinal manifestations of SARS-CoV-2 infection and virus load in fecal samples from the Hong Kong cohort and systematic review and meta-analysis

Supporting the health care workforce during the COVID-19 global epidemic

Detection of novel coronavirus by RT-PCR in stool specimen from asymptomatic child, China. Emerg Infect Dis

Comparison of different samples for 2019 novel coronavirus detection by nucleic acid amplification tests

Symbiotic gut microbes modulate human metabolic phenotypes

A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster

Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1

Hot air?

Air, surface environmental, and personal protective equipment contamination by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from a symptomatic patient

CDC Epicenters Program: Bioaerosol concentrations generated from toilet flushing in a hospital-based patient care setting

National Health Commission of the People's Republic of China: Update on the novel coronavirus pneumonia outbreak

AGA Institute Rapid Recommendations for Gastrointestinal Procedures During the COVID-19 Pandemic

Clinical features of patients infected with 2019 novel coronavirus in

World Health Organization: Rational Use of Personal Protective Equipment for Coronavirus Disease (COVID-19): Interim Guidance

Human coronaviruses: insights into environmental resistance and its influence on the development of new antiseptic strategies

Laboratory containment of SARS virus

China Internet News Center: National Health and Health Commission releases new coronary pneumonia diagnosis and treatment plan

Persistence of coronavirus on inanimate surfaces and their inactivation with biocidal agents

Antiseptic stewardship: biocide resistance and clinical implications