in wuhan, china...waiver of informed consent was obtained (id: wdry2020-k075). all ercps were...

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1 ERCP during the pandemic of COVID-19 in Wuhan, China Ping An 1,2,3 *, 1,2,3 *, Xu Huang 1,2,3 *, Xinyue Wan 1,2,3* , Yong Xiao 1,2,3 , Jun Zhang 1,2,3 , Jian Kang 1,2,3 , Jun Liu 1,2,3 , Dan Hu 1,2,3 , Yang Wang 1,2,3 , Haixia Ren 1,2,3 , Di Chen 1,2,3 , Xuefen Wang 1,2,3 , Zhongyin Zhou 1,2,3, Honggang Yu 1,2,31 Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China 2 Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China 3 Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China *Contributed equally and are joint first authors. Correspondence to: Prof Yu Honggang, Department of Gastroenterology, Renmin Hospital of Wuhan University. 99 Zhangzhidong Road, Wuhan 430060, Hubei Province, China. Tel: +86 13871281899, Fax: 027- 88042292, E-mail: [email protected]. Prof Zhongyin Zhou, Department of Gastroenterology, Renmin Hospital of Wuhan University. 99 Zhangzhidong Road, Wuhan 430060, Hubei Province, China. Tel: +86 13871281899, Fax: 027- 88042292, E-mail: [email protected]. Number of text: 2047 Keywords novel coronavirus; COVID-19; endoscopic retrograde cholangiopancreatography (ERCP); emergent ERCP Text 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65

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1

ERCP during the pandemic of COVID-19

in Wuhan, China

Ping An1,2,3*, 1,2,3*, Xu Huang1,2,3*, Xinyue Wan1,2,3*, Yong Xiao1,2,3, Jun Zhang1,2,3, Jian Kang1,2,3 ,

Jun Liu1,2,3, Dan Hu1,2,3, Yang Wang1,2,3, Haixia Ren1,2,3, Di Chen1,2,3, Xuefen Wang1,2,3, Zhongyin

Zhou1,2,3†, Honggang Yu1,2,3†

1 Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China

2 Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan

University, Wuhan, China

3 Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision,

Renmin Hospital of Wuhan University, Wuhan, China

*Contributed equally and are joint first authors.

Correspondence to:

Prof Yu Honggang, Department of Gastroenterology, Renmin Hospital of Wuhan University. 99

Zhangzhidong Road, Wuhan 430060, Hubei Province, China. Tel: +86 13871281899, Fax: 027-

88042292, E-mail: [email protected].

Prof Zhongyin Zhou, Department of Gastroenterology, Renmin Hospital of Wuhan University. 99

Zhangzhidong Road, Wuhan 430060, Hubei Province, China. Tel: +86 13871281899, Fax: 027-

88042292, E-mail: [email protected].

Number of text: 2047

Keywords novel coronavirus; COVID-19; endoscopic retrograde cholangiopancreatography

(ERCP); emergent ERCP

Text

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We read with great interest the recent articles by Repici et al1 and Soetikno et al.2 An outbreak of

a novel coronavirus pneumonia has rapidly spread through the whole country and is now a

worldwide pandemic. Up to March 30, the National Health and Health Commission of China has

reported a total of 82,423 confirmed cases in 31 provinces, 3306 cases of deaths, and total 615,699

confirmed cases worldwide.3 With the development of the pandemic, more countries have become

involved in this serious battle against the virus.

ERCP is an important and effective procedure of choice for biliary decompression. Despite the

highly infectious danger in COVID-19 outbreak areas, ERCP is still required for patients with

emergent biliary obstruction and for those who cannot wait until the next available elective list.

Direct contact, airborne droplets and touch contamination, and uncertain fecal-oral transmission

greatly increase the infection risk of ERCP procedures.4

To guarantee the safety of healthcare workers and patients for ERCP procedures, we established

infection prevention measures and standard operating procedures in our endoscopy center of

gastroenterology department to guarantee a safe environment to protect both patients and

healthcare personnel. Here, we retrospectively reviewed ERCP procedures in 31 patients during

the pandemic of COVID-19 to evaluate the safety and essential protection measures.

Patients with acute obstructive cholangitis, aggravated bile duct obstruction (rapid increased serum

total bilirubin [TBIL]), acute biliary pancreatitis, and common bile duct (CBD) gallstones with

fever, abdominal pain, and jaundice received ERCPs during the outbreak. COVID-19 screening

examinations including chest CT scans, complete blood tests, virological nuclei acid PCR tests

(nasal and oropharyngeal swab samples), and COVID-19 IgM/IgG were mandatory for all patients

and the people accompanying those patients before ERCP, except for emergent cases. COVID-19

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patients were admitted in designated wards. Other patients negative to COVID-19 infection spent

6 days of observation and preparation to transfer from 2 buffer zone wards (with 3 days of

observation per ward) to GI department wards. COVID-19–related symptoms including fever,

cough, chest pain, and dyspnea were kept under observation during the whole hospitalization, and

COVID-19 screenings were considered once these alert symptoms were presented. The study

protocol was approved by the ethics committee of Renmin Hospital of Wuhan University, and

waiver of informed consent was obtained (ID: WDRY2020-K075). All ERCPs were performed

with the patient under conscious sedation with propofol and pethidine, and the patient was

monitored by an anesthesiologist or endoscopist during the procedures.

After ERCPs, COVID-19 patients returned to designated wards, and uninfected patients were

admitted back to the buffer zone or GI wards for further treatments and observations.

During the outbreak of COVID-19 in Wuhan, from February 1 to March 31, 31 ERCPs were

performed for hospitalized patients admitted in Renmin Hospital of Wuhan University. The

median age of patients was 61 years (range 40-84 years) with the majority being male patients (19

M:12 F). Most patients had comorbidities, and up to 41.9% of patients had hypertension. Anorexia

(29 [93.4%]), fatigue (29 [93.4%]), and jaundice (23 [74.2%]) were the common symptoms. A

total of 19.4% of patients (6 cases) had fever, and 35.5% (11 patients) had abdominal pain. The

indications that necessitated ERCP included CBD gallstones (15 [48.4%]), acute biliary

pancreatitis (5 [16.1%]), and carcinoma (cholangiocarcinoma [8, 25.8%], ampullary cancer [1,

3.2%], and duodenal papillary carcinoma [2, 6.5%]). Most patients (21 [67.7%]) underwent

COVID-19 screening and then were admitted to wards by transferring from buffer zones to the GI

department, whereas 32.3% of patients (10 cases) finished the screening post-ERCP for emergent

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situations, including acute obstructive cholangitis and acute biliary pancreatitis (5 cases [16.1%],

respectively).

One patient who underwent emergent ERCP tested positively to COVID-19 nuclei acid in

oropharyngeal swab samples taken right before the procedure. This patient was later confirmed as

an asymptomatic carrier of COVID-19. At the time of this manuscript submission, none of the

other patients, their accompanying persons, or healthcare workers in our endoscopy center were

reported to have the COVID-19 infection.

In the current new era of the COVID-19 outbreak and rapidly evolving epidemiology, hospitals

have become one of the highest-risk places for both healthcare personnel and patients. With the

dramatic development of this pandemic, the risk of aerosol-generating medical procedures

(AGMPs) gained extensive attention, especially for upper endoscopic procedures, including

esophagogastroduodenoscopy (EGD), ERCP, and EUS, which carry the highest risk of aerosols.

Current guidelines and consensus recommended that patient management should be based on the

risk assessment of the COVID-19 infection, which included the patient’s exposure history (if he

stayed in a high-risk area during the previous 14 days and had contact with an infected person) and

typical symptoms regarding fever, cough, breathlessness, and diarrhea. Personal protective

equipment (PPE) were suggested to be provided accordingly. 5 However, given that atypical

symptoms without fever and respiratory presentations and current community transmission from

asymptomatic patients with COVID-19 have already been documented (and false-negative results

of virological test in some cases), it is challenging to identify all COVID-19 patients before ERCP

procedures. Furthermore, for patients who needed urgent ERCP, fever, abdominal pain, anorexia,

and diarrhea were common seen and greatly increased the complexity of differentiation. Therefore,

in the standard operating procedure of our ERCP team, we regarded all new patients as potential

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COVID-19 candidates regardless of whether the patients were considered low or high risk for

COVID-19.

Although all patients were asked to screen for COVID-19 before ERCP, some emergent cases

could not wait for the results. In these emergent cases, samples were taken for virus screening right

before the procedure. It is important to differentiate community infection from nosocomial

infection of the virus. One COVID-19 patient was confirmed in the first buffer zone ward after the

ERCP procedure and was confirmed as having a community infection. Our measurements

successfully identified this infected patient and prevented risky transmission. By the date of this

article submission, no other patients, accompanying people, or medical workers in our endoscopic

center were reported and diagnosed as having the COVID-19 infection.

In conclusion, our measures guaranteed that all healthcare workers in our endoscopy center,

patients, and accompanying persons would avoid COVID-19 infection and successfully identified

a virus-infected case during the procedure. Our experiences and measures for ERCP would help

others to establish optimal measures or standard operating procedures to avoid further

unrecognized spread of the disease.

Acknowledgements

This work was partly supported by the grant from the National Natural Science Foundation of

China (Grant No. 81672387 to Yu Honggang), and the National Natural Science Foundation of

China (Grant No. 81302131 to Ping An).

REFERENCES

1. Repici A, Maselli R, Colombo M, et al. Coronavirus (COVID-19) outbreak: what the department

of endoscopy should know. Gastrointest Endosc. Epub 2020 Mar 14.

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2. Soetikno R, Teoh AY, Kaltenbach T, et al. Considerations in performing endoscopy during the

COVID-19 pandemic. Gastrointest Endosc. Epub 2020 Mar 27.

3. The National Health and Health Commission of China. Available at: http://en.nhc.gov.cn/2020-

02/02/c_76098.htm.

4. Beilenhoff U, Biering H, Blum R et al. Reprocessing of flexible endoscopes and endoscopic

accessories used in gastrointestinal endoscopy: Position Statement of the European Society of

Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and

Associates (ESGENA) - Update 2018. Endoscopy 2018;50:1205–34

5. European Centre for Disease Prevention and Control. Personal protective equipment (PPE)

needs in healthcare settings for the care of patients with suspected or confirmed novel coronavirus

(2019-nCoV) 2020. Stockholm, Sweden: European Centre for Disease Prevention and Control;

2020.

Figure Legends

Figure 1. Pre-ERCP management.

Figure 2. ERCP and endoscopic center management.

Figure 3. Personal protective equipment of ERCP for high-risk patients. A, N95 mask,

disposable hairnet, goggles, protective suit, 1 pair of gloves, 2 pairs of shoe covers. B, Lead

apron and thyroid shields. C, Positive pressure ventilation hood. D, Long-sleeved

waterproof disposable gown, another pair of gloves. E, Disposable sheet isolates between

endoscopist and patient.

Figure 4. Post-ERCP management.

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* We will use email addresses only for questions related to this article ** Type of relationship may include: full-time or part-time employee, independent contractor, consultant, research or other grant recipient, paid speaker

or teacher, membership on advisory committee or review panels, ownership interest (product royalty/licensing fees, owning stocks, shares, etc.), relationship of a spouse or partner, or any other financial relationship.

1

Checklist Journal CME Conflict of Interest: Disclosure and Attestation

Lead Author: Yu Honggang

Article:

Endoscopic Retrograde Cholangiopancreatography

during the pandemic of COVID-19 in Wuhan, China.

Date: Apr 6, 2020

The purpose of this form is to identify all potential conflicts of interests that arise from financial relationships between any author for this article and any commercial or proprietary entity that produces healthcare-related products and/or services relevant to the content of the article. This includes any financial relationship within the last twelve months, as well as known financial relationships of authors’ spouse or partner. The lead author is responsible for submitting the disclosures of all listed authors, and must sign this form at the bottom. Additional forms may be submitted if the number of authors exceeds the space provided.

Lead Author: Yu Honggang No disclosures Email Address*: [email protected]

No financial relationships with a commercial entity producing health-care related products and/or services relevant to this article.

Company Type of Relationship** Content Area (if applicable)

Author: An Ping No disclosures Email Address*: [email protected]

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Author: Huang Xu No disclosures Email Address*: [email protected]

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Disclosure and Attestation Form

* We will use email addresses only for questions related to this article ** Type of relationship may include: full-time or part-time employee, independent contractor, consultant, research or other grant recipient, paid speaker

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2

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