Introduction
The coronavirus disease 2019 (COVID-19) pandemic has placed the world under unprecedented
pressure. Gastroenterology departments required drastic reorganization to deal with
mitigation measures. Specifically, they were forced to reduce the routine workload
to prevent the risk of infection spreading, with consequent quantitative and qualitative
impairment of the health services provided and potential impact on patients’ healthcare
status [1]. Even though mitigation measures resulted in a reduction in the impact of illness
on healthcare system capacity, they led to deferral of elective procedures in accordance
with recommendations from several society guidelines [2]
[3]
[4]
[5]
[6].
All endoscopic procedures, especially upper endoscopy, are considered aerosol-generating
and adequate personal protection equipment (PPE) should be used [7]. Therapeutic procedures may theoretically increase healthcare professional (HCP)
exposure due to their longer duration [8]. Little is known regarding the risk of contamination of patients and HCPs when endoscopic
procedures are performed and PPE is used during endoscopic procedures.
Assessment of the overall impact of a crisis such as COVID-19 on clinical practice
is an essential and complex exercise. Upper gastrointestinal stenting in patients
with symptoms of dysphagia/obstruction due to malignant esophageal [9] or gastric outlet obstruction [10] should be considered a high-priority endoscopic procedure [5], which should be performed immediately, or at least within 1 to 2 weeks [5].
The impact of COVID-19 mitigation measures in self-expandable metal stent (SEMS) procedures
has not yet been reported. Therefore, the aim of our study was to assess the impact
of COVID-19 mitigation measures on upper gastrointestinal stenting during the severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak, as well as the use
of adequate PPE and risk of contamination for patients and HCP.
Patients and methods
We conducted a multicenter, retrospective study in six European centers of consecutive
patients who underwent stenting for upper gastrointestinal obstruction (excluding
biliary obstruction) during the second half of the SARS-CoV-2 outbreak (from the 35th
day to the 60th day since the first national SARS-CoV-2 patient was registered) and
compared it to the same period 1 year before the SARS-CoV-2 outbreak. The number of
stents placed during the first half of the SARS-CoV-2 outbreak (from the 10th day
to the 35th day) was also identified. All participating centers were tertiary care
centers, with significant experience and expertise in upper gastrointestinal stenting.
Information on patient demographic characteristics (age and gender), medical history
(disease-causing luminal obstruction, cTNM staging, patient cardiovascular and respiratory
comorbidities), renal failure at presentation, ASA classification, hospitalization
before SEMS placement, SEMS indication (esophageal dysphagia or gastric outlet obstruction)
and dysphagia grade (Takitaʼs dysphagia grading [11]) or gastric outlet obstruction scoring system (GOOSS) [12] before and 7 days after SEMS placement was collected from medical records. In addition,
we collected data on procedural characteristics, such as stricture location and diameter,
and specifics of each procedure, such as SEMS characteristics and scope used. We also
collected information on the cumulative number of SARS-CoV-2 cases at each hospital
and respective country during the study period, COVID impact on each endoscopic unit
(number of procedures performed, endoscopists, nurses and infected personal in the
unit), number of people in the endoscopic suite during SEMS placement, fellow participation,
use of PPE, use of endoscopic suites with negative pressure or air purifiers, as well
as COVID status/symptoms of endoscopists, nurses, and anesthesiologists before and
14 days after the SEMS procedure.
Each center used its own clinical decision making regarding which type of stent to
use. SEMS placed were nitinol stents, uncovered, partially covered or fully covered,
with body diameters ranging from 18 mm to 24 mm. SEMS were deployed under moderate
or deep sedation at the discretion of the endoscopist. They were deployed over-the-wire
or through-the-scope. Tumor length was estimated endoscopically or radiologically
using contrast medium injection. A stent measuring 2 to 4 cm longer than the stricture
was used to allow for a 1- to 2-cm extension above and below the proximal and distal
tumor borders. Technical success of SEMS placement was defined as successful deployment
of the SEMS in the correct position. Adverse events (AEs) were recorded. All dates
of disease diagnosis, hospitalization, SEMS placement, beginning of oral diet, hospital
discharge and AEs were recorded.
Statistical analysis
Categorical variables were described using absolute and relative frequencies, while
continuous variables were described using means and standard deviations or medians
and interquartile ranges (IQR). Comparison of patient characteristics during the COVID
outbreak period and the year before was performed using a Mann-Whitney U test for
continuous variables and a chi-square test for categorical variables. All reported P values were two-sided and P < 0.05 was considered statistically significant. Analyses were performed using SPSS
23.0 (IBM Corp., Armonk, New York, United States).
Results
Patient characteristics and SEMS outcomes (2020)
Twenty-nine patients were included. Baseline characteristics of the patients in whom
a SEMS was placed and procedure characteristics and related outcomes are summarized
in [Table 1] and [Table 2]. Median age was 68 years (IQR 62–71), with 13 patients (45 %) being female. Most
obstructions were caused by esophageal cancer (n = 11; 38 %), followed by gastric
cancer (n = 8; 28 %) and pancreatic cancer (n = 6; 21 %). Cardiovascular and respiratory
comorbidities were present in 13 (45 %) and 4 (14 %) patients, respectively. Only
four (14 %) of the SEMS were placed in patients with altered anatomy, while three
patients (10 %) had a previous SEMS placed for the same indication ([Table 1]).
Table 1
Baseline characteristics of patients with upper gastrointestinal obstruction who underwent
luminal stenting.
|
Global (n = 41)
|
2020 (n = 29)
|
2019 (n = 12)
|
P value
|
Female gender (n, %)
|
13 (44.8 %)
|
1 (8.3 %)
|
0.033
|
Age (median, IQR)
|
68 (62–71)
|
69 (62–76)
|
0.877
|
Gastrointestinal disease (n, %)
|
0.380
|
|
11 (37.9 %)
|
5 (41.7 %)
|
|
2 (6.9 %)
|
2 (16.7 %)
|
|
8 (27.6 %)
|
3 (25 %)
|
|
6 (20.7 %)
|
–
|
|
2 (6.9 %)
|
2 (16.7 %)
|
T staging (n, %)
|
0.650
|
|
1 (3.4 %)
|
–
|
|
1 (3.4 %)
|
1 (8.3 %)
|
|
9 (31 %)
|
6 (50 %)
|
|
16 (55.2 %)
|
4 (33.3 %)
|
|
2 (6.9 %)
|
1 (8.3 %)
|
N staging (n, %)
|
0.649
|
|
6 (20.7 %)
|
1 (8.3 %)
|
|
21 (72.4 %)
|
10 (83.3 %)
|
|
2 (6.9 %)
|
1 (8.3 %)
|
M staging (n, %)
|
0.439
|
|
10 (34.5 %)
|
6 (50 %)
|
|
17 (58.6 %)
|
5 (41.7 %)
|
|
2 (6.9 %)
|
1 (8.3 %)
|
ASA classification (median, IQR)
|
2 (2–3)
|
3 (2–3)
|
0.300
|
Comorbidities (n, %)
|
|
13 (44.8 %)
|
9 (75 %)
|
0.098
|
|
4 (13.8 %)
|
5 (41.7 %)
|
0.093
|
Anatomy (n, %)
|
0.058
|
|
25 (86.2 %)
|
9 (75 %)
|
|
1 (3.4 %)
|
1 (8.3)
|
|
3 (10.3 %)
|
2 (16.7 %)
|
Previous SEMS placed for same indication
|
3 (10.3 %)
|
2 (16.7 %)
|
0.620
|
SEMS indication (n, %)
|
0.325
|
|
14 (48.3 %)
|
8 (66.7 %)
|
|
15 (51.7 %)
|
4 (33.3 %)
|
Esophageal dysphagia
|
|
32 (15–25)
|
71 (18–408)
|
0.658
|
|
5 (35.7 %)
|
6 (75 %)
|
0.183
|
|
0 (0 %)
|
3 (37.5 %)
|
0.036
|
|
4 (3–5)
|
4 (4–5)
|
0.920
|
|
6 (5–9)
|
9 (6–11)
|
0.659
|
Gastric outlet obstruction
|
|
12 (5–29)
|
10 (4–14)
|
0.477
|
|
14 (93.3 %)
|
3 (75 %)
|
0.386
|
|
3 (20 %)
|
0 (0 %)
|
1.000
|
|
0 (0–1)
|
1 (1–2)
|
0.037
|
|
5 (3–9)
|
6 (3–9)
|
0.736
|
ASA, American Society of Anesthesiologists; GOOSS, gastric outlet obstruction scoring
system; IQR, interquartile range; SEMS, self-expandable metal stent.
1 Other: ampullary cancer (n = 2); cholangiocarcinoma (n = 1); metastatic cervical
cancer (n = 1)
Table 2
Procedure characteristics and related outcomes.
|
Global (n = 41)
|
2020 (n = 29)
|
2019 (n = 12)
|
P value
|
Stricture location (n, %)
|
0.116
|
|
7 (24.1 %)
|
3 (25 %)
|
|
7 (24.1 %)
|
5 (41.7 %)
|
|
3 (10.3 %)
|
–
|
|
4 (13.8 %)
|
–
|
|
1 (3.4 %)
|
1 (8.3 %)
|
|
5 (17.2 %)
|
1 (8.3 %)
|
|
1 (3.4 %)
|
–
|
|
–
|
2 (16.7 %)
|
|
1 (3.4 %)
|
–
|
Scope used for SEMS placement (n, %)
|
0.749
|
|
8 (27.6 %)
|
4 (33.3 %)
|
|
15 (51.7 %)
|
5 (41.7 %)
|
|
1 (3.4 %)
|
–
|
|
5 (17.2 %)
|
3 (25 %)
|
SEMS placement technique (n, %)
|
0.272
|
|
17 (58.6 %)
|
7 (58.3 %)
|
|
12 (41.4 %)
|
5 (41.6 %)
|
SEMS body diameter (median, mm)
|
20 (18–22)
|
22 (19–22.5)
|
0.475
|
SEMS flange diameter (median, mm)
|
26 (24–26)
|
26.5 (24–27.5)
|
0.358
|
SEMS length (median, mm)
|
110 (89–121.5)
|
105 (100–120)
|
0.919
|
Fluoroscopy use (n, %)
|
26 (89.7 %)
|
9 (75 %)
|
0.334
|
Sedation (n, %)
|
0.166
|
|
10 (34.5 %)
|
2 (16.7)
|
|
19 (65.5 %)
|
9 (75 %)
|
|
–
|
1 (8.3 %)
|
Technical success (n, %)
|
29 (100 %)
|
12 (100 %)
|
1.000
|
Esophageal dysphagia
|
|
2 (2–3)
|
2 (2–2)
|
0.212
|
|
1 (1–1)
|
1 (0–2)
|
0.602
|
|
2 (0–3)
|
3 (0–9)
|
1.000
|
Gastric outlet obstruction
|
|
2 (2–3)
|
3 (3–3)
|
0.124
|
|
1 (1–1)
|
1 (1–2)
|
0.885
|
|
2 (1–5)
|
3 (2–6)
|
0.810
|
Adverse event (n, %)
|
5 (17 %)
|
2 (16.7 %)
|
0.983
|
Pain
|
1 (3.4 %)
|
1 (8.3 %)
|
Overgrowth/ingrowth
|
2 (6.9 %)
|
–
|
Bleeding
|
1 (3.4 %)
|
–
|
Nausea/vomiting
|
1 (3.4 %)
|
–
|
Migration
|
–
|
1 (8.3 %)
|
Time from SEMS placement to AE (median, days)
|
2 (2–22)
|
13 (0–25)
|
0.095
|
IQR, interquartile range; SEMS, self-expandable metal stent; TTS, through-the-scope.
The majority of SEMS were placed using therapeutic gastroscopes (n = 15; 52 %), followed
by conventional gastroscopes (n = 8; 28 %) and ultrathin scopes (n = 5; 17 %). SEMS
placement technique was through-the-scope in 17 patients (59 %) and over-the-wire
in the remaining 12 (41 %). Technical success was achieved in all patients, with Takita
grades and GOOSS at 1 week after SEMS placement improving to a median of 2 (IQR 2–3)
in both scores. Early AEs were reported in 5 patients (17 %), after a median of 2
days (IQR 2–22) ([Table 2]).
Mitigation measures impact
From the 35th day to the 60th day after the first reported case of SARS-CoV-2 in each country, a total of 1028
endoscopic procedures were performed in the six European centers (median of 161.5
procedures). This corresponds to a reduction of 80 % compared to the same time period
in 2019, when a total of 5174 endoscopic procedures were performed (median of 799.5
procedures). The number of endoscopists and nurses working in the endoscopy department
during the study period also dropped by 70 % and 56 %, respectively. The burden of
SARS-CoV-2 cases varied among hospitals, with admissions ranging from 0.03 % to 3.8 %
of the total number of national cases ([Table 3]).
Table 3
Mitigation measures impact on procedures performance in 2020 compared to the same
period in 2019.
|
Overall
|
Hospital São João
|
Leeds
|
Essen
|
Radboud
|
Clinic
|
Humanitas
|
2020
|
2019
|
2020
|
2019
|
2020
|
2019
|
2020
|
2019
|
2020
|
2019
|
2020
|
2019
|
2020
|
2019
|
SEMS placed from D10 to D34
|
33
|
44
|
1
|
5
|
13
|
9
|
5
|
5
|
8
|
7
|
1
|
1
|
5
|
7
|
SEMS placed from D35 to D60 (study period)
|
29
|
12
|
8
|
2
|
6
|
0
|
3
|
2
|
5
|
5
|
2
|
1
|
5
|
2
|
Number of endoscopists working during study period
|
35
|
116
|
8
|
18
|
10
|
50
|
3
|
9
|
4
|
12
|
5
|
16
|
5
|
11
|
Number of nurses working during study period
|
65
|
146
|
12
|
22
|
30
|
60
|
5
|
11
|
9
|
24
|
5
|
22
|
4
|
7
|
Number of procedures performed during study period
|
1028
|
5174
|
163
|
732
|
160
|
1198
|
226
|
573
|
158
|
640
|
130
|
1164
|
191
|
867
|
Staff endoscopists infected during study period
|
9
|
–
|
0
|
–
|
7
|
–
|
0
|
–
|
0
|
–
|
2
|
–
|
0
|
–
|
Staff nurses infected during study period
|
4
|
–
|
0
|
–
|
4
|
–
|
0
|
–
|
0
|
–
|
0
|
–
|
0
|
–
|
Cumulative number of SARS-CoV-2 cases in hospital during study period
|
3727
|
–
|
490
|
–
|
190
|
–
|
30
|
–
|
292
|
–
|
2260
|
–
|
465
|
–
|
Cumulative number of SARS-CoV-2 cases in country during study period
|
463133
|
–
|
12748
|
–
|
33718
|
–
|
99891
|
–
|
36487
|
–
|
87295
|
–
|
192994
|
–
|
Endoscopic suite
|
Air filtration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Negative pressure
|
5 (17.2 %)
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
5 (100 %)
|
–
|
Air filter
|
7 (24.1 %)
|
2 (16.7 %)
|
7 (87.5 %)
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
2 (100 %)
|
Mask used
|
–
|
|
None
|
2 (6.9 %)
|
12 (100 %)
|
–
|
2 (100 %)
|
2 (33.3 %)
|
–
|
2 (100 %)
|
–
|
5 (100 %)
|
–
|
1 (100 %)
|
–
|
2 (100 %)
|
Surgical mask
|
5 (17.2 %)
|
–
|
–
|
–
|
–
|
–
|
–
|
5 (100 %)
|
–
|
–
|
–
|
–
|
–
|
FFP2/FFP3
|
22 (75.9 %)
|
–
|
8 (100 %)
|
–
|
4 (66.7 %)
|
3 (100 %)
|
–
|
–
|
–
|
2 (100 %)
|
–
|
5 (100 %)
|
–
|
Protective eyewear
|
–
|
|
None
|
4 (13.8 %)
|
10 (83.3 %)
|
–
|
2 (100 %)
|
2 (33.3 %)
|
–
|
2 (100 %)
|
2 (40 %)
|
5 (100 %)
|
–
|
1 (100 %)
|
–
|
–
|
Goggles
|
13 (44.8 %)
|
2 (16.7 %)
|
–
|
–
|
–
|
3 (100 %)
|
–
|
3 (60 %)
|
–
|
2 (100 %)
|
–
|
5 (100 %)
|
2 (100 %)
|
Face shield
|
12 (41.4 %)
|
–
|
8 (100 %)
|
–
|
4 (66.7 %)
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
Number of gloves pairs
|
–
|
|
One
|
10 (34.5 %)
|
12 (100 %)
|
–
|
2 (100 %)
|
2 (33.3 %)
|
3 (100 %)
|
2 (100 %)
|
5 (100 %)
|
5 (100 %)
|
–
|
1 (100 %
|
–
|
2 (100 %)
|
Two
|
19 (65.5 %)
|
–
|
8 (10 %)
|
–
|
4 (66.7 %)
|
–
|
–
|
–
|
–
|
2 (100 %)
|
–
|
5 (100 %)
|
–
|
Hairnet
|
22 (75.9 %)
|
–
|
8 (100 %)
|
–
|
4 (100 %)
|
–
|
3 (100 %)
|
–
|
–
|
–
|
2 (100 %)
|
–
|
5 (100 %)
|
–
|
Shoe covers
|
10 (34.5 %)
|
–
|
8 (100 %)
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
2 (100 %)
|
–
|
–
|
–
|
Gown
|
–
|
|
No
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
Apron
|
3 (10.3 %)
|
8 (66.7 %)
|
–
|
2 (100 %)
|
2 (33.3 %)
|
–
|
–
|
1 (20 %)
|
5 (100 %)
|
–
|
1 (100 %)
|
–
|
–
|
Full disposable gown
|
26 (89.7 %)
|
4 (33.3 %)
|
8 (100 %)
|
–
|
4 (66.7 %)
|
3 (100 %)
|
2 (100 %)
|
4 (80 %
|
–
|
2 (100 %)
|
–
|
5 (100 %)
|
2 (100 %)
|
Endoscopic staff
|
Number of endoscopists (n, %)
|
–
|
|
1
|
20 (69 %)
|
8 (66.7 %)
|
7 (87.5 %)
|
2 (100 %)
|
4 (66.7 %)
|
1 (33.3 %)
|
2 (100 %)
|
5 (100 %)
|
3 (60 %)
|
2 (100 %)
|
1 (100 %)
|
1 (80 %)
|
–
|
2
|
9 (31 %)
|
4 (33.3 %)
|
1 (12.5 %)
|
–
|
2 (33.3 %)
|
2 (66.7 %)
|
–
|
–
|
2 (40 %)
|
–
|
–
|
4 (20 %)
|
2 (100 %)
|
3
|
–
|
|
Number of nurses (n, %)
|
5 (17 %)
|
4 (33.3 %)
|
–
|
–
|
–
|
–
|
1 (50 %)
|
–
|
1 (20 %)
|
–
|
–
|
5 (100 %)
|
2 (100 %)
|
1
|
17 (59 %)
|
6 (50 %)
|
7 (87.3 %)
|
2 (100 %)
|
–
|
3 (100 %)
|
1 (50 %)
|
5 (100 %)
|
2 (40 %)
|
2 (100 %)
|
1 (100 %)
|
–
|
–
|
2
|
7 (24 %)
|
2 (16.7 %)
|
1 (12.7 %)
|
–
|
6 (100 %)
|
–
|
–
|
–
|
2 (40 %)
|
–
|
–
|
–
|
–
|
Anesthesiologist (n, %)
|
16 (55 %)
|
8 (66.7)
|
7 (87.5 %)
|
0 (0 %)
|
0 (0 %)
|
–
|
0 (0 %)
|
0 (0 %)
|
2 (40 %)
|
5 (100 %)
|
0 (0 %)
|
0 (0 %)
|
5 (100 %)
|
2 (100 %)
|
Fellow present (n, %)
|
6 (21 %)
|
8 (66.7 %)
|
0 (0 %)
|
2 (100 %)
|
1 (16.7 %)
|
–
|
1 (33.3 %)
|
0 (0 %)
|
0 (0 %)
|
5 (100 %)
|
0 (0 %)
|
1 (100 %)
|
4 (80 %)
|
0 (0 %)
|
SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SEMS, self-expandable
metal stent.
A total of 29 SEMS were placed for upper gastrointestinal obstruction (esophageal
dysphagia: 48.3 % [n = 14] and gastric outlet obstruction: 51.7 % [n = 15]) during
the study period, corresponding to an increase of 241 % compared to the same time
period in 2019, when a total of 12 SEMS were placed.
With the exception of renal failure in patients with esophageal dysphagia, which was
significantly higher in 2019 (0 [0 %] vs 3 [38 %]; P = 0.036), and GOOSS before SEMS placement in patients with gastric outlet obstruction,
which was significantly lower in 2020 (0 [0–1] vs 1 [1–2]; P = 0.037), no other significant differences were found between the two time periods
regarding median time from dysphagia/obstructive symptoms onset to SEMS placement,
hospitalization, stricture estimated diameter, Takita grade before SEMS placement,
beginning of oral diet and hospital discharge ([Table 1] and [Table 2]).
Endoscopic staff and personal protection equipment
The endoscopic procedures were performed in rooms with negative pressure in 17 % of
the cases, with an additional 17 % being performed in rooms with air purifiers ([Table 3]).
No significant differences were found between the two time periods regarding the number
of endoscopists in the endoscopic suite (2020: one endoscopist 69 % vs 2019: one endoscopist 67 %), nurses and anesthesiologists (2020: 55 % vs 2019: 67 %). However, fellows’ involvement was significantly lower in 2020 (21 %
vs 67 %; P = 0.01) ([Table 3]).
Regarding PPE, in 2020, the majority of procedures were performed using facial masks
(FFP2/FFP3 in 76 % and surgical masks in 17 %), protective eyewear (goggles in 45 %
and face shield in 41 %), two pairs of gloves (65 %), hairnet (76 %) and full disposable
gowns (90 %); shoe covers were used in 34 % of the procedures. In 2019, all procedures
were performed without facial mask, hairnet or shoe covers, and only one pair of gloves;
most procedures were performed without protective eyewear (83 %) and with aprons only
(67 %) ([Table 3]).
COVID-19 status
In 2020, no SEMS procedures were performed in COVID-19-confirmed patients, but 55 %
of the patients were not tested for SARS-CoV-2 before the procedure ([Table 4]); even though two patients (7 %) presented with respiratory symptoms and one (3 %)
had fever before SEMS placement, and all of them were real-time polymerase chain reaction
(RT-PCR) test-negative. One patient (3 %) tested positive for SARS-CoV-2 after the
procedure and two patients (7 %) reported respiratory symptoms up to 14 days after
SEMS placement ([Table 4]).
Table 4
Coronavirus disease 19 status in healthcare professionals and patients before and
14 days after endoscopic procedure.
n (%)
|
Global (n = 29)
|
Hospital São João (n = 8)
|
Leeds (n = 6)
|
Essen (n = 3)
|
Radboud (n = 5)
|
Clinic (n = 2)
|
Humanitas (n = 5)
|
Before
|
After
|
Before
|
After
|
Before
|
After
|
Before
|
After
|
Before
|
After
|
Before
|
After
|
Before
|
After
|
Endoscopist COVID-19 status
|
|
4 (13.8 %)
|
3 (10.3 %)
|
–
|
–
|
–
|
–
|
–
|
–
|
2 (40 %)
|
1 (20 %)
|
2 (100 %)
|
2 (100 %)
|
–
|
–
|
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
|
25 (86.2 %)
|
26 (89.7 %)
|
8 (100 %)
|
8 (100 %)
|
6 (100 %)
|
6 (100 %)
|
3 (100 %)
|
3 (100 %)
|
3 (60 %)
|
4 (80 %)
|
–
|
–
|
5 (100 %)
|
5 (100 %)
|
Nurse COVID-19 status
|
|
7 (24.1 %)
|
3 (10.3 %)
|
4 (50 %)
|
–
|
–
|
–
|
–
|
–
|
1 (20 %)
|
1 (20 %)
|
2 (100 %)
|
2 (100 %)
|
–
|
–
|
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
|
22 (75.9 %)
|
26 (89.7 %)
|
4 (50 %)
|
8 (100 %)
|
6 (100 %)
|
6 (100 %)
|
3 (100 %)
|
3 (100 %)
|
4 (80 %)
|
4 (80 %)
|
–
|
–
|
5 (100 %)
|
5 (100 %)
|
Anesthesiologist COVID-19 status
|
|
2 (6.9 %)
|
1 (3.4 %)
|
–
|
–
|
–
|
–
|
–
|
–
|
2 (40 %)
|
1 (20 %)
|
–
|
–
|
–
|
–
|
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
|
13 (44.8 %)
|
14 (48.2 %)
|
8 (100 %)
|
8 (100 %)
|
–
|
–
|
–
|
–
|
–
|
1 (20 %)
|
–
|
–
|
5 (100 %)
|
5 (100 %)
|
|
14 (48.3 %)
|
14 (48.2 %)
|
–
|
–
|
6 (100 %)
|
6 (100 %)
|
3 (100 %)
|
3 (100 %)
|
3 (60 %)
|
3 (60 %)
|
2 (100 %)
|
2 (100 %)
|
–
|
–
|
Patient COVID-19 status
|
|
13 (44.8 %)
|
3 (10.3 %)
|
8 (100 %)
|
2 (25 %)
|
–
|
–
|
1 (33.3 %)
|
–
|
1 (20 %)
|
–
|
1 (50 %)
|
–
|
2 (40 %)
|
1 (20 %)
|
|
–
|
1 (3.4 %)
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
1 (20 %)
|
–
|
–
|
–
|
–
|
|
16 (55.2 %)
|
23 (79.3 %)
|
–
|
6 (75 %)
|
6 (100 %)
|
6 (100 %)
|
2 (66.7 %)
|
3 (100 %)
|
4 (80 %)
|
4 (80 %)
|
1 (50 %)
|
2 (100 %)
|
3 (60 %)
|
2 (40 %)
|
|
–
|
2 (6.9 %)
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
2 (40 %)
|
COVID-19, Coronavirus disease 2019.
The majority of endoscopists (86 %), nurses (76 %), and anesthesiologists (87 %) were
not tested for SARS-CoV-2 before the procedure. No medical staff involved in the SEMS
procedures developed COVID-19 14 days after the procedure ([Table 4]). However, nine of 35 endoscopists and four of 65 nurses involved in other procedures
got infected during the overall study period ([Table 3]).
Discussion
The COVID-19 pandemic has been and still is affecting daily practice of gastrointestinal
endoscopy worldwide. Several recommendations and statements have already been published
in order to ensure safety of patients and endoscopy unit personnel [2]
[3]
[4]
[5]
[6]. With the significant increase in hospital admissions of COVID-19 patients, European
hospitals have markedly reduced elective endoscopies, and the majority of resources
have been directed to the COVID-19 pandemic. A recent survey reported a reduction
in endoscopic volume of 91 % compared to the volume before the COVID-19 outbreak [13]. In our study, a drop of 80 % in the number of endoscopic procedures was noticed.
The number of endoscopists and nurses working in the endoscopy department also dropped
by 70 % and 56 %, respectively. However, the number of staff involved in SEMS placement
was not impacted, with similar numbers of endoscopic staff present in the endoscopic
suite compared to 2019. Nonetheless, fellows’ participation in SEMS placement reduced
from 67 % to 21 %. This can be explained by the demand for stringent standards of
infection control, rationing the use of necessary PPE [14] and redeployment of fellows to support critical services of each hospital as a result
of the COVID-19 pandemic.
It is unknown for how long the COVID-19 pandemic will last. Despite a universal desire
to return to usual endoscopic and clinical care, patients may still avoid undergoing
scheduled endoscopic procedures because of fear of being infected by SARS-CoV-2, but
likely also because they consider it safe to further postpone an endoscopic procedure.
It has been reported in Italy that up to 30 % of patients do not show up to the endoscopic
unit despite being scheduled [15]. Nonetheless, in our study, patients with symptomatic obstruction did not seem to
have avoided or delayed going to the hospital. An increase of 241 % (from 12 to 29)
in the number of SEMS placements was observed when compared to the same time period
in 2019. The reason for this unexpected increase remains uncertain. Potentially, it
could be related to a lower number of interventional cases in 2019; however, it could
also reflect a change of practice in oncology during COVID times, with more patients
being referred for definitive palliation rather than being considered for chemo- and/or
radiotherapy due to fear of increased risks or lack of capacity to administer it.
There were relatively more T4 patients in 2020, which could suggest that some patients
have waited longer themselves or had to wait for treatment with chemotherapy and/or
radiotherapy. In addition, 40 % of the patients had no metastases at presentation,
which could suggest that chemotherapy and/or radiotherapy had indeed been delayed
or not performed due to a preferred choice for COVID-19 care in the hospital. As the
number of procedures was small, we do not have sufficient evidence to support any
solid conclusion. Of interest, major patient baseline characteristics and post-stenting
management policies did not differ between the two time periods.
The risk of COVID-19 after endoscopic procedures and the risk factors associated with
it have not yet been established. Endoscopy presents a source of aerosolization, potentially
increasing the risk of infection with SARS-CoV-2 for endoscopy staff; however, preliminary
reports suggest a low risk for professional and patient infection [16]. Repici et al [17] reported only one confirmed case of COVID-19 in 802 patients who underwent an endoscopic
procedure. Although we did not place SEMS in COVID-19-confirmed patients, 55 % of
the patients were not tested for SARS-CoV-2 before the procedure. Only one patient
tested positive for SARS-CoV-2 after the procedure; however, he had not been tested
before. None of the medical staff involved in the SEMS procedures developed COVID-19
symptoms, even though 26 % of endoscopists and 6 % of nurses involved in other procedures
got infected during the study period; however, the source of their infection has not
been elucidated. These findings are in line with a recent Italian report describing
the rate of COVID-19 infected physicians in gastroenterology units [18]. The entire gastroenterology department of Hospital São João in Portugal underwent
serological testing at the end of the study, with the results being negative for all
of them. Infection prevention and control has been shown to be highly effective in
assuring the safety of both HCP and patients [19]
[20]
[21]
[22]. In our study, negative pressure or rooms with air purifiers were only available
in 34 % of the procedures; 76 % and 17 % of our procedures were performed with FFP2/FFP3
and surgical masks, respectively. In one of the hospitals, due to a shortage of PPE,
FFP2 masks were only allowed for RT-PCR-positive cases or for highly suspicious but
test-negative cases. While a recent guideline has suggested that surgical masks can
be used in this setting [23], there remains a significant false-negative rate for RT-PCR testing and concern
for infection between the time of testing and the procedure. Protective eyewear, offering
additional protection against aerosol droplets from patients [24], was also used in 86 % of the procedures.
Limitations of our study include its retrospective design, being conducted in six
tertiary referral centers. None of the patients included were, as far as we know,
COVID-19-positive, so it is not possible to assess whether the risk of HCP infection
after therapeutic endoscopy is higher when performed in confirmed COVID-19 patients.
Nonetheless, we present data from centers for which the SARS-CoV-2 outbreak had a
major impact on their endoscopic activity during the outbreak period and were located
in geographical areas with high rates of community transmission.
Conclusion
This is the first multicenter international study to quantify the impact of COVID-19
on endoscopic placement of SEMS in patients with upper gastrointestinal obstruction.
Upper gastrointestinal stenting increased during the SARS-CoV-2 outbreak period. This
could be related to yearly variation in the number of procedures (unrelated to the
pandemic) or reflect a change of oncologic treatment practice during COVID times.