Brief Title
Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic.
Official Title
Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic: the ChoCO-WSES Prospective Multicenter Observational Study.
Brief Summary
Gangrenous cholecystitis is the most common complication of acute cholecystitis.
Preliminary data showed that COVID-19 patients have a high risk to present necrotic
cholecystitis.
The Cholecystitis under COVID-19 pandemic WSES (ChoCO-W) study aims to investigate risk
factors and high-risk patients to develop necrotic cholecystitis during this pandemic.
Detailed Description
Background:
Gangrenous cholecystitis is the most common complication of acute cholecystitis affecting
around 15% (range 2-30%) of patients and it occurs as a result of ischemia with necrosis of
the gallbladder wall [1].
It is related to an increased mortality rate (mortality rate ranging between 15 and 50%)
compared with non-necrotic acute cholecystitis[2].
Retrospective studies that investigated risk and predictive factors related to gangrenous
cholecystitis showed that males, older patients with diabetes, coronary artery disease, and
other comorbidities are at risk to present with gangrenous cholecystitis. [1-3] Another study
identified longer delay time prior to hospital admission and low white blood cell count as
independent risk factors affecting mortality and indicated the presence of diabetes mellitus,
higher blood levels of aspartate aminotransferase, alanine aminotransferase, alkaline
phosphatase and total bilirubin, pericholecystic fluid in abdominal ultrasonography, and
conversion from laparoscopic surgery to open surgery as risk factors increasing mortality [2]
In any case, the treatment of GC is similar to that of patients with AC but in the presence
of GC, cholecystectomy can be difficult because of adhesions, insufficient anatomic control,
complications like bleeding, and injury to bile ducts.
There is high variability in the reported conversion rate to be 30% to 50% [4], down to 8.7%
[5]. These results are probably due to a careful preoperative selection of patients for
laparoscopic cholecystectomy and early surgery [6].
Hunt et al [7] reported decreased morbidity and mortality rates with the implementation of
laparoscopic cholecystectomy for GC.
Onder et al [2] showed that mortality was higher in cases in which conversion to open surgery
occurred.
Recently, many authors reported necrotic and perforated cholecystitis as the most common
complication of COVID-19 pneumonia [8-9-10].
A recent multi-society position paper suggested to consider percutaneous drainage of the
gallbladder after the failure of conservative therapy with antibiotics but highlighted that
advanced age, or other factors of higher COVID-19 risk, cannot be regarded as sufficient to
indicate this alternative treatment except in real conditions of the impracticability of
cholecystectomy [11].
In the lack of evidence and guidelines about the management of a patient with acute
cholecystitis during COVID-19 pandemic, laparoscopic cholecystectomy, at most preceded by
percutaneous trans-gallbladder drainage (PTGBD) in high surgical risk patients, remains the
gold standard for the treatment of acute cholecystitis on COVID-19 patients, with high
morbidity rate and length of hospital stay that increases the risk of spreading the virus
among health care staff and negative COVID-19 patients.
The aim is to study all patients presenting acute cholecystitis to improve their management.
The rationale for the trial:
To evaluate the management of acute cholecystitis focusing on the treatments and the outcomes
of operative or non-operative management in COVID (+) and COVID (-) patients with the aim to
improve outcomes, decreasing morbidity and mortality rates related to emergency setting and
high-risk surgical patients.
Objectives:
1. Evaluate the prevalence of cholecystitis, in female and male patients during COVID-19
pandemic.
2. Evaluate the risk factors for necrosis or gangrenous cholecystitis in COVID-19 patients.
3. Evaluate the clinical outcomes of early (<72h from the onset of symptoms) versus delayed
(>72h from the onset of symptoms) cholecystectomy, and of cholecystostomy in terms of
mortality and morbidity.
Primary objective:
The hypothesis is that COVID-19 patients should not be treated conservatively (antibiotics
only/ percutaneous drainage of the gallbladder and antibiotics) for the high risk of
progressing to necrotic and then perforated cholecystitis.
It was reported that COVID-19 disease predisposes to both venous and arterial
thromboembolism, explained by excessive inflammation, hypoxia, immobilization, and diffuse
intravascular coagulation. In particular, critically ill patients with SARS-CoV-2 showed a
high risk to present thromboembolic events.
Secondary objective:
To investigate the risk factors for necrotic cholecystitis in the general population and to
assess the right timing for surgery.
Study Design:
Prospective Multicenter Observational Study.
Study population:
All patients admitted to the surgical department with clinical and histological diagnosis of
acute cholecystitis (with and without gangrenous cholecystitis).
Inclusion criteria:
Patients of all ages and sex admitted in the emergency department for acute cholecystitis,
aged >=18 yo.
Exclusion criteria:
Patients aged< 18 yo.
Period:
2020/10/01 to 2021/05/31
Data collection:
All epidemiological, clinical, and surgical data will be collected in an online case report
form.
Statistical analysis:
This is a prevalence study and univariate and multivariate analysis of each scheduled
parameter will be carried out. In the statistical analysis, the investigators will
differentiate the data also by gender. All patients having cholecystitis including those
having gangrenous cholecystitis will be included in the analysis. Previous World Society of
Emergency Surgery prospective studies on sepsis (Sartelli et al, WJES, 2019; 14: 34; Sartelli
et al, 2015; 10: 61) showed that this is feasible and the investigators' aim is getting
exactly the number of patients of these two studies. It is expected that the COVID-19
patients will be less than the negative ones for two reasons:
1. the incidence of COVID-19 infection;
2. trial to treat them conservatively often outside the hospitals. Non-parametric methods
will be used in case of a small number of COVID-19 patients which work even if the
groups are less than 20.
Ethical Aspects:
This is an observational study, it will not attempt to change or modify the clinical practice
of the participating physicians. The study will meet and conform to the standards outlined in
the Declaration of Helsinki and Good Epidemiological Practices.
Every clinical center attending the study is responsible for Ethics Committee approval. Every
local investigator is responsible for data collection and data entry. All surgeons involved
in the patients' recruitment will be included in the research authorship.
Methods and assessments:
Every clinical center involved in the study will be identified by a number assigned before
starting to enter data. A link to an anonymous online case report form will be sent by mail
to collaborators, to collect data.
Safety Considerations:
There are no safety issues.
Informed consent:
This observational study will not attempt to change or modify the laboratory or clinical
practices of the participating physicians, consequently, informed consent will not be
required. Every patient included in this study will be asked to sign a written consent to
authorize the anonymous treatment of personal data if it is not already provided at the
admission in the ward.
Data Management and Statistical Analysis:
Every investigator is responsible for entering data on one online case report form for every
patient included in the study.
The statistical analysis will be carried out with the supervision of Prof.Fikri Abu-Zidan.
Expected Outcomes of the Study To demonstrate the correlation between necrotic cholecystitis
and predisposition to thromboembolism in COVID-19 patients. To identify high-risk patients
for developing necrotic cholecystitis.
Dissemination of Results and Publication Policy The outcomes of this study will be analyzed
and published in a scientific journal with an IF.
Duration of the Project
1 year
Budget No budget study
Financing and Insurance Not applicable
Study Type
Observational [Patient Registry]
Primary Outcome
Correlation between COVID-19 pneumonia and necrotic cholecystitis
Condition
Cholecystitis, Acute
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
800
Start Date
October 1, 2020
Completion Date
September 2021
Primary Completion Date
May 31, 2021
Eligibility Criteria
Inclusion Criteria:
All patients presenting acute cholecystitis during COVID 19 pandemic, aged >=18 yo
Exclusion Criteria:
Patients presenting with acute cholecystitis aged <18 yo
Gender
All
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
, +33665787872, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04542512
Organization ID
06012020
Responsible Party
Principal Investigator
Study Sponsor
Poissy-Saint Germain Hospital
Collaborators
World Society of Emergency Surgery
Study Sponsor
, ,
Verification Date
October 2020