RISK FACTORS FOR NECROTIC CHOLECYSTITIS DURING COVID-19 PANDEMIC: THE ChoCO WSES PROSPECTIVE MULTICENTER OBSERVATIONAL STUDY

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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