Introduction
In response to the prolonged lockdown period and implemented measures of social distancing/personal
hygiene, most European countries are now (June 2020) experiencing a suppression of
the COVID-19 viral pandemic [1 ]. This post-outbreak sustained (i. e., > 14 days) viral deceleration is being referred
to as the “post-lockdown” phase of the COVID-19 pandemic. Sadly, at its height, the
COVID-19 pandemic led to innumerable deaths throughout Europe, including many frontline
health care professionals (HCPs) fighting the virus [2 ]. Therefore, we must remain vigilant in protecting HCPs, including our endoscopy
unit personnel, by continuing to follow personal protective equipment (PPE) recommendations
[3 ].
It must be stressed however, that the observed deceleration of the viral outbreak
is not equivalent to the disappearance of COVID-19 transmission, as a large reservoir
of the virus remains present in most European countries [4 ]. This generates the risk of future COVID-19 outbreaks as the protocols of infection
control are gradually relaxed, as multiple viral outbreak clusters in various countries
are now showing. Therefore, strategies aiming to triage, separate, and track gastrointestinal
(GI) endoscopy patients, as outlined in our original Position Statement, remain highly
relevant and necessary in this new post-lockdown phase of the pandemic [3 ]. An additional new tool, potentially available for GI endoscopy units to further
assist in patient care, is pre-endoscopy viral testing to more accurately triage patients
and/or health care personnel through the identification of COVID-19 viral RNA using
nasopharyngeal swabbing [5 ].
The prolonged lockdown period across Europe resulted in the cancellation of elective
GI endoscopies as only emergent/urgent endoscopies were performed [6 ]. As GI endoscopy is largely used for screening, early diagnosis, and treatment of
digestive tract cancers, there is a growing concern about a possible mid- or long-term
increase in the GI cancer burden because of the many elective GI endoscopy procedures
that were cancelled [7 ]. Competition for endoscopy slots between those cancelled endoscopy procedures and
those procedures previously scheduled is now occurring and needs to be addressed.
We must do this by striking a careful balance between the ongoing need to maintain
infection prevention and control (IPC) protocols within the endoscopy unit and the
need to increase endoscopy procedure capacity. Despite there being an excessive backlog
of endoscopy cases, there remains no consensus on the best way to efficiently yet
safely re-open access for elective endoscopy procedures. Moreover, the status of COVID-19
in Europe is neither uniform nor generalizable across the continent since some regions
of Europe may not yet be in the “post-lockdown” phase of the pandemic.
The aim of this present Position Statement is to provide updated evidence-based guidance
on endoscopy practice for the post-lockdown phase of the COVID-19 pandemic. Moreover,
in this updated Position Statement, guidance is given on IPC in the post-lockdown
period, on the emerging role of COVID-19 viral testing, and on issues related to returning
to full endoscopy capacity. Unless otherwise stated, all the guidance statements from
the original Position Statement of the European Society for Gastrointestinal Endoscopy (ESGE) and the European Society of Gastroenterology and Endoscopy Nurses and Associates
(ESGENA) remain valid and applicable in the post-lockdown phase [3 ]. Last, to better understand how the COVID-19 pandemic was impacting endoscopy units
in Europe, ESGE and ESGENA surveyed their members on the status of their endoscopy
practice as related to the COVID-19 pandemic. Thus, in addition to the updated guidance
recommendations offered within this Position Statement, we also report selected results
from our member survey.
Methods
As in our original Position Statement, 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’ as MeSH terms between February 1, 2020 and May 31, 2020 to identify relevant
publications that could inform this updated Position Statement. When applicable, recommendations
by international medical bodies such as the World Health Organization (WHO) and the
European and US Centers for Disease Prevention and Control have been considered and
adapted as well.
A survey with 35 questions on COVID-19 management in GI endoscopy units was sent to
all ESGE individual members in May 2020. The survey was divided into four main content
areas (demographics, endoscopy unit organization, personal protective equipment (PPE)
use, and training/research). Overall, 595 responses were received, and are summarized
in Appendix 1s (available online-only in Supplementary Material).
A. Infection prevention and control
A. Infection prevention and control
1 We recommend that during the post-lockdown phase, infection prevention and control
(IPC) policies proposed in our original COVID-19 position statement remain in place.
These policies apply to IPC training, patient triage, social distancing, isolation,
separation, telemedicine, appropriate use of personal protective equipment (PPE),
personal hygiene/disinfection, and patient tracking.
2 We recommend that IPC interventions should be tailored to the local availability
and affordability of resources, while keeping in consideration the local prevalence
of COVID-19 and community viral transmission rates.
Endoscopy unit personnel should be considered vulnerable HCPs [8 ]. This is related to the aerosol-generating nature of GI endoscopy procedures, especially
upper endoscopy procedures [9 ]. Patient triage must be adapted to the new pattern of epidemiology of COVID-19 as
defined by WHO ([
Fig. 1
]) and testing (see below) [10 ]
[11 ]. Contact and clustering of the infection, as well as occupational hazards, are now
well-defined risk factors for isolation and separation interventions. When and where
available, filtering face piece (FFP) respirators (i. e., N95 masks or the equivalent)
should be used by the endoscopy unit personnel, regardless of the endoscopic procedure
and patient status [8 ]
[12 ].
Fig. 1 Proposal for reopening gastrointestinal endoscopy units according to World Health
Organization (WHO) epidemiological regional risk stratification and testing if available
[10 ]. Otherwise follow previous recommendations for use of personal protective equipment
(PPE).
According to our member survey, however, approximately one third of European GI endoscopy
units reported PPE shortages during the lockdown phase of the pandemic. Where PPE
shortages continue to exist, stratification of the risk of viral transmission according
to the type of endoscopy procedure is justified, especially in areas with little or
no known community transmission of the disease. In addition, most of the responses
to our survey consider prolonged upper GI procedures to have the highest risk for
COVID-19 transmission. Patients at high risk for having COVID-19 infection should
be isolated and separated within the endoscopy unit to avoid viral exposure of other
endoscopy unit patients. However, according to our survey, isolation and separation
of patients may be problematic because of the lack of adequate endoscopy unit infrastructure.
In such cases, alternative policies, such as separating the morning/afternoon time
slots of patients or alternating the endoscopy unit personnel to minimize their risk
of reciprocal viral transmission, are advocated.
Post-endoscopy patient tracking/contact remains of primary importance for IPC because
of the relatively long asymptomatic latency period of the COVID-19 virus [13 ]. Post-endoscopy patient tracking will allow for the potential identification of
patients who become symptomatic with COVID-19 following their GI endoscopy procedure.
According to our member survey, most endoscopy units did not contact or track patients
after endoscopy. We believe this should be corrected, and patients should be contacted
and tracked following their endoscopy procedure. In some countries, tracking by mobile
phone application was to be implemented, representing a possible surrogate.
B. COVID-19 viral testing
B. COVID-19 viral testing
1 Given the current lack of high-level evidence, the exclusive use of serology or rapid
antigen testing for pre-endoscopy patient triage cannot be recommended at this time.
2 Where readily available, we suggest that pre-endoscopy viral testing based on molecular
diagnosis (polymerase chain reaction [PCR] or isothermal nucleic acid amplification
[INAAT]) be considered for all patients. See [Fig. 1 ].
For low prevalence situations and where there are shortages of FFP respirators, it
appears reasonable to use a standard surgical mask when performing endoscopy (upper
and/or lower GI endoscopy procedures) in asymptomatic patients thought to be at low
risk for having COVID-19 infection combined with a negative PCR test. Use of other
PPE (e. g., gloves, hair cover, protective eyewear, waterproof gowns, booties/shoe
covers), as recommended in our original Position Statement, should continue to be
used [3 ].
Pre-endoscopy viral testing in symptomatic patients, where viral testing is negative,
may identify patients so that GI endoscopy procedures are not postponed.
3 Where there is limited availability of molecular testing, we recommend that viral
testing be reserved only for those patients considered to be at high risk for having
COVID-19 infection.
Polymerase chain reaction (PCR) testing
Gastrointestinal endoscopy is an aerosol-generating procedure with a high risk of
exposure to pathogens causing acute respiratory infections such as COVID-19 [13 ]. Stratifying patients according to their probability of having COVID-19 infection
based on their self-reported symptoms or risk factors is unreliable. Although viral
transmission of COVID-19 usually occurs more commonly from symptomatic patients, transmission
of COVID-19 from asymptomatic patients is occurring [14 ]. Studies have shown varying rates of asymptomatic COVID-19-infected persons [16 ]
[17 ]
[18 ]. For example, in a population screening study from Iceland, 43 % of COVID-19-positive
persons were asymptomatic at the time of diagnosis [19 ]. The relatively long incubation period, that may last up to 2 weeks, and the suboptimal
accuracy of the clinical signs/symptoms for the diagnosis of COVID-19, may explain
the high rate of asymptomatic or possibly presymptomatic persons [20 ].
Molecular diagnosis based on direct identification of viral RNA with reverse transcription
(RT)-PCR or with isothermal nucleic acid amplification testing (INAAT) has demonstrated,
at least in vitro , high levels of sensitivity and specificity of ≥ 95 % [21 ]
[22 ]
[23 ]
[24 ]. Additional advantages of molecular viral diagnosis are the potential to create
efficient point-of-care testing and the short time for processing test results. Coupling
the high accuracy with the relatively low prevalence of the disease, the negative
predictive value approaches 100 %.
A meta-analysis of the effectiveness of face masks has suggested that the use of FFP-2/N95
respirators compared with the use of standard surgical masks is not associated with
a statistically significant lower risk of viral infection, at least in non-aerosol-generating
procedures [25 ]. In our survey, nearly one third of respondents favored the integration of pre-endoscopy
viral testing. However, a pre-endoscopy testing policy might not be easily implemented
in endoscopy units because of multiple barriers. First, there is the need for an adequate
organizational structure as patients after being tested, must remain self-isolated
for 48–72 hours to prevent undetectable pre-endoscopy infection. Second, most countries
suffer from shortages of testing reagents or manpower when considering the high volume
of testing that is performed at the population level to identify infected patients.
Third, most endoscopy centers do not have the availability and/or the affordability
of in-house PCR. Fourth, endoscopy centers must have a policy for dealing with false-positive
test results that could be higher than the true-positive results [26 ]. Finally, it must be taken into consideration that viral testing can result in a
false-negative test, especially when the nasopharyngeal swab is not performed correctly
or in patients with a low pharyngeal viral load. For situations in which pre-endoscopy
viral testing is not routinely or readily available, viral testing should be reserved
for those patients thought to be at high risk of having COVID-19 infection based on
their pre-endoscopic IPC risk stratification as previously recommended by ESGE-ESGENA
[3 ].
Antigen and serology testing
Despite its biological plausibility and preliminary in vitro results, the initial
clinical experience of immunological identification of the COVID-19 antigen from nasopharyngeal
swabbing has shown suboptimal results in terms of sensitivity as compared with PCR
[27 ]. If any of the antigen detection tests that are currently under development or subsequently
commercialized demonstrate adequate performance characteristics, they could potentially
be used as pre-endoscopy triage tests to rapidly identify patients who are very likely
to have COVID-19, thereby reducing or eliminating the need for expensive molecular
confirmatory testing [28 ]. Despite the availability of serology testing in most countries, its use to risk-stratify
the pre-endoscopy patient is marginal because of the window period before infected
individuals develop antibodies [29 ].
Testing can be considered for endoscopy unit personnel when there has been a breach
of IPC, such as when an assumed COVID-19-negative patient becomes positive during
post-endoscopy tracking or where there has been incorrect use of PPE with COVID-19-positive
patients, or any time an HCP develops COVID-19-like symptoms.
Restarting GI endoscopy
1 We recommend that during the post-lockdown phase, a return to full GI endoscopy procedure
capacity be pursued in those areas without evidence of community transmission of COVID-19,
while continuing to adhere to IPC measures.
2 We recommend that prioritization of GI endoscopy procedures by clinical or oncological
indication should be required in those areas with limited endoscopic capacity.
3 We 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 protective policies for those patients at high risk of contracting
COVID-19 infection or of having poor outcomes from COVID-19 infection (e. g., elderly,
having comorbidities, immunocompromised).
4 We recommend that in the post-lockdown phase, GI endoscopy units involved in endoscopy
training and research activities gradually restart their endoscopy training programs
and research activities, provided these activities will not further delay needed GI
endoscopic procedures.
According to our member survey (Appendix 1s ), most of the endoscopy units reported a substantial decrease in the volume of GI
endoscopy procedures performed during the lockdown phase (75 % to 100 % endoscopy
volume reduction). This decrease is explained by the fact that most endoscopy units
limited their endoscopic activity to urgent indications only.
In addition, most endoscopy units are expecting insufficient capacity/manpower/local
resources when endoscopy activity is restarted. This may be explained by at least
two factors: (i) there is an overlap between the rescheduled lockdown endoscopy patient
list and the new endoscopy appointments to be scheduled, generating a competition
between the endoscopy waiting lists; (ii) IPC policies prevent a full return to endoscopy
capacity because of the longer times required for room disinfection and the ongoing
separation of intake/outbound pathways within the endoscopy unit for COVID-19 patients
[5 ]
[8 ]. There is concern however, about missed/preventable diagnosis of GI cancers if endoscopy
procedures are inordinately delayed [7 ].
For this reason, priority stratification of GI endoscopy procedures according to indication
is recommended ([
Table 1
]). Priority for endoscopy should be given to those patients with alarm symptoms or
those at higher risk of GI cancer based upon previous examination findings/results
(e. g. positive fecal immunochemical test [FIT], radiographic suspicion or evidence).
Conversely, surveillance of patients at average or reduced risk of cancer, such as
post-polypectomy or post-surgery colorectal cancer (CRC) patients may continue to
be temporarily postponed. In addition, the opening of new time-slots for rescheduled
endoscopy procedures must be considered based upon local availability and resources.
Table 1
Prioritization of gastrointestinal (GI) endoscopy procedures stratified by clinical
indication.
Urgent/emergent
Acute upper/lower GI bleeding with hemodynamic instability
Capsule/enteroscopy for urgent/emergent bleeding
Anemia with hemodynamic instability
Foreign body in esophagus and/or high-risk foreign body in the stomach
Obstructive jaundice
Acute ascending cholangitis
High priority
Endoscopic treatment of high-grade dysplasia (HGD) or early intramucosal cancer in
the esophagus, stomach, or large colonic polyps at high risk of submucosal invasion
Malignant stricture stenting
Percutaneous endoscopic gastrostomy (PEG)/Percutaneous endoscopic jejunostomy (PEJ)/Nasojejunal
tube
Upper GI fistula/leakage
Dysphagia or dyspepsia with alarm symptoms present
Upper GI bleeding without hemodynamic instability
Rectal bleeding
Colonoscopy for melena after negative upper GI endoscopy
Severe anemia with no hemodynamic instability
Tissue acquisition needed for the initiation of systemic therapy/surgery
Colonoscopy within organized positive fecal occult blood test (FOBT)/fecal immunochemical
test (FIT) colorectal cancer (CRC) screening program
Foreign body in the stomach, low-risk
Benign stricture requiring dilation/stenting
Radiologic evidence of mass
Lymph node endoscopic ultrasound (EUS) sampling
Gallstone-related pancreatitis
Pancreatic mass/stricture
Biliary stricture dilation
Pancreaticobiliary stent replacement
Necrosectomy
Moderate priority
Endoscopic treatment of esophageal or gastric low-grade dysplasia (LGD)
Duodenal polyp
Ampullectomy
Band ligation/non-emergency
Iron-deficiency anemia
Pancreatic cyst (depending on risk features)
Biliary stricture/no urgency (no cholangitis, no jaundice, etc.)
Submucosal lesion EUS sampling
Achalasia (peroral endoscopic myotomy [POEM], balloon dilation)
Positive guaiac fecal occult blood test (gFOBT)/FIT, outside of an organized regional/
national screening program
Low priority
Surveillance of Barrett’s esophagus, gastric atrophy/intestinal metaplasia, inflammatory
bowel disease, primary sclerosing cholangitis
Post endoscopic or surgical resection of cancer
Post-polypectomy surveillance
Diagnosis/Surveillance of hereditary nonpolyposis colorectal cancer (HNPCC) and other
hereditary syndromes
Workup of irritable bowel syndrome (IBS)-related symptoms
Workup of reflux disease, dyspepsia (no alarm symptoms)
Screening in high-risk patients for esophageal, stomach or colon cancer
Bariatric endoscopic surgery
An additional factor to be considered is patients’ fear of being infected with the
COVID-19 virus while visiting the GI endoscopy unit. For this reason, policies aimed
at protecting patients at higher risk of contracting COVID-19 and having poor outcomes
from COVID-19 infection (e. g., elderly, having comorbidities, immunocompromised)
are recommended and acceptable. Alternatively, direct patient contact through telemedicine
should encourage patients at high risk for GI disease/malignancy, such as those with
a positive FIT, to undergo endoscopy. For patients extremely reluctant to undergo
endoscopy, non-endoscopic testing may be considered.
According to our survey, the great majority of endoscopy training programs were interrupted
during the COVID-19 pandemic lockdown period. Many respondents reported that a general
reduction in endoscopic skill acquisition was expected, affecting every domain of
endoscopic activities. For trainees in endoscopy, supplementation of hands-on training
with educational alternatives (e. g. endoscopy simulator or animal models where available)
could mitigate the potentially detrimental effect on skill acquisition due to the
decreased volume of endoscopy procedures involving trainees. We must remember that
gastrointestinal endoscopy is not simply a technical discipline, it is also cognitive.
Thus, trainees can also further develop their cognitive endoscopic skills by use of
online learning and viewing of endoscopy videos and technical training videos [7 ]. In addition, according to the ESGE survey, research activities have been delayed
or completely suspended, apart from specific COVID-19 endoscopy-related projects.
For these reasons, a return to normal endoscopy training schedules and research activities
is desirable, provided no further delays in GI endoscopy procedure rescheduling are
caused.
Disclaimer
ESGE 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 the 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 position statements are intended
to be an educational device to provide information that may assist endoscopists 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 particular treatment.