Abbreviations
CDC:
Centers for Disease Control and Prevention
ECDC:
European Centre for Disease Prevention and Control
ESGE:
European Society of Gastrointestinal Endoscopy
ESGENA:
European Society of Gastroenterology and Endoscopy Nurses and Associates
FFP:
filtering facepiece
HCP:
healthcare professional
INAAT:
isothermal nucleic acid amplification
IDSA:
Infectious Diseases Society of America
IPC:
infection prevention and control
PCR:
polymerase chain reaction
PPE:
personal protective equipment
SARS-CoV-2:
severe acute respiratory syndrome coronavirus 2
WHO:
World Health Organization
Introduction
The ongoing COVID-19 pandemic has entered a new phase following the introduction and
availability of highly effective vaccination therapies that have modified the epidemiology
of severe disease [1]
[2]
[3]
[4]
[5]. Conversely, viral variants (e. g. the Delta variant) with increased transmissibility
have developed and become dominant drivers of the pandemic in Europe and throughout
the world. This has led to uncertainty regarding infection prevention, viral control
strategies, and vaccination regimens [6]. In Europe, as of October 2021, vaccination rollout, with complete double-dose immunization
status, has reached 73.5 % of the population, although with a high intercountry variability
(ranging from 25 % to 95 %) [7]. In some countries, the administration of a third (“booster”) dose has been initiated
for individuals considered at high risk of negative outcomes from COVID-19 [8]
[9]. It must also be noted that currently, COVID-19 vaccination rollout is highly imbalanced
between high- and low-income countries, with vaccinated population percentages in
the latter being as low as 1 % [10]. This has prompted a flow of vaccines into these areas of the world, where strategies
for endoscopy resumption and procedure scheduling should be adapted to local epidemiology
and regional risk stratifications. For such affected regions of the world, please
refer to World Health Organization (WHO) guidelines and guidance documents from the
European Society of Gastrointestinal Endoscopy and the European Society of Gastroenterology
and Endoscopy Nurses and Associates (ESGE-ESGENA) and their adaptations to low-resources
settings [11]
[12]
[13]
[14]
[15].
Despite the worldwide introduction of COVID-19 vaccinations, gastrointestinal (GI)
endoscopy continues to entail a significant risk of infection and morbidity from COVID-19,
for both health care professionals (HCPs) and patients. Infection prevention and control
(IPC) has been shown to be dramatically effective in assuring the safety of both patients
and HCPs [16]
[17]. ESGE (www.esge.com) and ESGENA (www.esgena.org) continue to join forces in this
updated Position Statement, to provide ongoing guidance during the pandemic to help
assure the highest level of GI endoscopy care and protection against COVID-19 for
both our patients and endoscopy unit personnel. This guidance is based upon the best
available evidence in the current context of COVID-19 vaccines and SARS-CoV-2 viral
variants.
Methods
As in our previous ESGE-ESGENA Position Statements on GI endoscopy and COVID-19 [14]
[15], a PubMed/MEDLINE search was performed once again, using “severe acute respiratory
distress syndrome coronavirus 2,” “COVID-19,” “endoscopy, digestive system endoscopy,”
“gastrointestinal endoscopic examination, therapy,” “vaccination”, and “viral variants”
as MeSH terms, between February 1, 2020 and October 15, 2021, to identify relevant
publications that could inform this updated Position Statement. When applicable, recommendations
by international medical bodies, such as WHO, the European Centre for Disease Prevention
and Control (ECDC), and the US Centers for Disease Control and Prevention (CDC), have
also been considered and adapted.
Recommendations
1 ESGE-ESGENA recommend that infection prevention and control (IPC) regimens recommended
in our previous COVID-19 Position Statements remain in place. This applies to patient
triage, IPC training, social distancing/mask wearing, patient isolation/separation,
role of telemedicine, personal hygiene/disinfection, and appropriate use of personal
protective equipment (PPE).
2 ESGE-ESGENA recommend that where there are shortages of filtering facepiece (FFP)
or KN95 masks, it is reasonable to use a standard surgical mask when performing endoscopy
(upper and/or lower GI endoscopy procedures) in patients who are negative in polymerase
chain reaction (PCR) or isothermal nucleic acid amplification (INAAT) testing within
48 hours before their endoscopy examination, or who provide documentation of full
COVID-19 vaccination status or recovery from COVID-19 infection within the past 6
months (e. g. the European Union Digital COVID Certificate. Other PPE (e. g., gloves,
hair cover, protective eyewear, waterproof gowns, booties/shoe covers), should continue
to be used as recommended in our previous Position Statements [14]
[15].
3 ESGE-ESGENA recommend that all patients arriving at the GI endoscopy unit be required
to wear masks and observe social distancing.
Pre-endoscopy screening for COVID-19 symptoms remains central in disease prevention
and control. Given the current state of knowledge, WHO advises that all IPC measures
for COVID-19 in health facilities be maintained for vaccinated health care workers
[18]. In addition, the United States CDC state that HCPs should continue to follow all
current IPC recommendations, including those addressing the use of PPE, to protect
themselves and others from SARS-CoV-2 infection [19]. However, for vaccinated HCPs working in facilities located in areas with low community
transmission and caring for asymptomatic vaccinated patients, a downgrading from FFP-2/KN95
masks to surgical masks can be considered [20].
4 ESGE-ESGENA recommend that all patients presenting for GI endoscopy be required to
provide either:
(a) A negative viral test (PCR or INAAT) performed within 48 hours before their scheduled
GI endoscopy; or
(b) Documentation of full COVID-19 vaccination status or recovery from COVID-19 infection
within the past 6 months (e. g. European Union Digital COVID Certificate).
5 ESGE-ESGENA do not recommend prioritization based on COVID-19 immunity status of
patients awaiting GI endoscopy, since this does not appear to be ethical.
Notwithstanding the reported high effectiveness of vaccination, recent data suggest
a waning antibody response in vaccinated individuals after approximately 6 months
[4]
[21]
[22]
[23]
[24]. This is also reported in individuals after recovery from SARS-CoV-2 infection,
with breakthrough COVID-19 infections being reported both in vaccinated individuals
and in persons with acquired natural immunity [25]
[27]. In addition, these infections have been shown to be asymptomatic or paucisymptomatic,
while remaining capable of transmitting the virus [28]
[29]. For these reasons, to maximize patient and HCP protection, ESGE-ESGENA suggest
that regardless of vaccination or previous infection status, all individuals presenting
for GI endoscopy should provide proof of a negative viral test with PCR or INAAT performed
within 48 hours before their scheduled procedure, or documentation of full COVID-19
vaccination status or recovery from COVID-19 infection within the past 6 months (e. g.
the European Union Digital COVID Certificate).
In places where access to viral testing is limited or unavailable, we suggest that
asymptomatic patients presenting for GI endoscopy with official documentation of full
vaccination status or recent recovery from COVID-19 infection should not be obliged
to undergo pre-endoscopic viral testing. This is based on evidence that asymptomatic
COVID-19 infection is extremely rare in patients scheduled for GI endoscopy, ranging
from 0 to 1.5 % in prevaccination era published series, but still highly dependent
on local epidemiology [30]. In addition, this low value must be considered alongside the high rate of vaccinated
HCPs and the continuous use of PPE, which should reduce infection risk even more.
All patients without proof of full vaccination or recovery from recent infection must
in any case undergo viral testing before endoscopy.
6 ESGE-ESGENA recommend that pre-endoscopy viral testing (PCR or INAAT) be performed
immediately in all symptomatic patients. Where viral testing is negative, patients
may undergo GI endoscopy, thus avoiding postponement of procedures.
ESGE recommends that both patients and HCPs with COVID-19 symptoms undergo immediate
viral testing with PCR or INAAT. This is based on recommendations from both American
and European centers for disease control that all symptomatic patients and HCPs, regardless
of vaccination status, should receive a viral test immediately upon symptom onset
[19]
[30]
[31]. This would mean that no symptomatic patient should undergo GI endoscopy before
having a highly accurate negative test (PCR or similar). If a symptomatic patient
presents with a reliable, highly sensitive negative viral test, the GI endoscopic
procedure should not be postponed.
7 ESGE-ESGENA do not recommend the use of serology or rapid antigen testing (including
home self-testing kits) for pre-endoscopy patient triage.
The Infectious Diseases Society of America (IDSA) has developed guidelines on serologic
testing for the diagnosis of COVID-19. In detail, the IDSA recommends against the
use of serological testing to diagnose past SARS-CoV-2 infection, since precise definitions
of timing and antibody kinetics are lacking [32]. In addition, serological tests have no role in the diagnosis of asymptomatic infection.
The use of antigen testing or of self-testing should not be accepted as adequate screening
prior to GI endoscopy because of the uncertain quality of specimen collection, performance
of the self-testing procedure, and low test sensitivity [33].
8 ESGE-ESGENA recommend that all healthcare professionals (HCPs) working in a GI endoscopy
unit be fully vaccinated against COVID-19.
9 ESGE-ESGENA recommend a return to full GI endoscopy procedure capacity in those areas
with an ongoing vaccination policy, while continuing to adhere to IPC measures.
10 ESGE-ESGENA recommend that GI endoscopy units involved in GI endoscopy training and
research activities resume their endoscopy training programs and research activities,
provided all involved individuals are fully immunized with regard to COVID-19 (i. e.,
vaccinated or recovered).
ESGE-ESGENA strongly recommends that all HCPs working in GI endoscopy units receive
a complete vaccination regimen. Full vaccination has been shown to substantially reduce
severe COVID-19 manifestations, intensive care unit need, and death [4]
[34]. ESGE-ESGENA believe that HCPs should follow their national policies and regulations,
including in some European countries where vaccination has now been made mandatory
for all HCPs. Whenever possible, HCPs without immunization should have no or only
limited patient contact. Moreover, any HCP working in GI endoscopy who develops COVID-19
symptoms, should not report to work and should immediately have PCR or INAAT viral
testing.
11 ESGE-ESGENA suggest that for HCPs who have recovered from COVID-19 infection, proof
of natural immunity (up to 6 months post-infection) may be considered equivalent to
vaccine immunity, provided the HCP can provide documentation of the previous infection
(PCR or INAAT test).
12 ESGE-ESGENA recommend that patients’ fears of contracting COVID-19 infection while
visiting a GI endoscopy unit should be properly addressed. This especially includes
having in place appropriate vaccination policies for HCPs and protective policies
for those patients at high risk of contracting COVID-19 or of having poor outcomes
from COVID-19 infection (e. g., unvaccinated elderly individuals, or those with comorbidities,
or who are immunocompromised).
13 ESGE-ESGENA do not recommend physical separation of patients based on vaccination
status since this does not seem to be logistically feasible or ethical, and since
vaccination for the general population is currently not mandatory.
Data suggest that most individuals who have recovered from COVID-19, even after mild
infections, carry some protection against re-infection from SARS-CoV-2 for at least
1 year [35]. However, post-vaccination studies show waning antibody titers and increased risk
of breakthrough infection 6 months after vaccination [8]
[23]. For this reason, it is reasonable to suggest a 6-month post-infection duration
of immunity that is equivalent to vaccine immunity for HCPs working in GI endoscopy
units, if proof of infection can be provided.
14 ESGE-ESGENA recommend that during the ongoing COVID-19 pandemic prioritization of
GI endoscopy procedures, based upon clinical and/or oncological indications, should
be optimized in those areas with limited endoscopic capacity.
We suggest referring to the previous ESGE-ESGENA Position Statements regarding the
priority to be given to GI endoscopy procedures according to indication [14]
[15].
Disclaimer
ESGE-ESGENA position statements represent a consensus of best practice based on the
available evidence at the time of preparation. They may not apply in all situations
and should be interpreted in light of specific clinical situations and resource availability.
Further controlled clinical studies may be needed to clarify aspects of these statements,
and revision may be necessary as new data appear. Clinical considerations may justify
a course of action at variance to these statements. ESGE-ESGENA position statements
are intended to be an educational device to provide information that may assist endoscopists
and GI endoscopy nurses in providing care to patients. They are not rules and should
not be construed as establishing a legal standard of care or as encouraging, advocating,
requiring, or discouraging any specific treatment.
