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: THE ChoCO WSES PROSPECTIVE MULTICENTER OBSERVATIONAL STUDY

Official Title

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

Brief Summary

      The ChoCO (Cholecystitis under COVID-19 pandemic) STUDY PROTOCOL 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.

      Preliminary data showed that COVID-19 patients have a high risk to present necrotic
      cholecystitis.

      Our aim is to investigate risk factors related to develop necrotic cholecystitis in COVID-19
      negative and positive patients carrying out a multicentric prospective observational study.
    

Detailed Description

      Background Gangrenous cholecystitis (GC) is the most common complication of acute
      cholecystitis (AC), 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 increased mortality rate (mortality rate ranging between 15 and 50%)
      compared with non-necrotic AC [2].

      Retrospective studies that investigated risk and predictive factors related to GC showed that
      males, older patients with diabetes, coronary artery disease, and other comorbidities are at
      risk to have GC. [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 presence of GC, cholecystectomy can be difficult because of
      adhesions, insufficient anatomic explorability, 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 multisocietary 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-gall bladder 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.

      Our aim is to study all patients, Covid-19 (+) and Covid-19 (-) presenting cholecystitis,
      including those having GC, to improve their management.

      Rationale for the trial:

      To evaluate the management of acute (complicated) cholecystitis focuzing on the treatments
      and the outcomes of operative or non-operative management in COVID (+) and COVID (-) patients
      with the aim to improve the results, reducing morbidity and mortality rates related to
      emergency setting and high-risk 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 Our hypothesis is that COVID-19 patients should not be treated
           conservatively (antibiotics only/ percutaneous drainage of the gallbladder 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 Our aim is to investigate the risk factors for necrotic
           cholecystitis in the general population.

           Study Design:

           Prospective Multicenter Observational Study.

           Study population:

           All patients admitted to the surgical department with clinical and histologic 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 2021/04/31 Data
           collection: all the epidemiological, clinical, and surgical data will be collected by a
           google form sheet that will be sent by mail to the participating centers.

           Statistical analysis:

           Prevalence study and univariate and multivariate analysis of each scheduled parameter.
           In the statistical analysis, we will differentiate the data also by gender.

           Prevalence study and univariate and multivariate analysis of each scheduled parameter.
           In the statistical analysis we will differentiate the data also by gender. It is very
           important to study all patients having cholecystitis including those having gangrenous
           cholecystitis. Previous World Society of Emergency Surgery prospective studies on sepsis
           (Sartelli et al, WJES, 2019; 14: 34; Sartelli et al, 2015; 10: 61) show that this is
           feasible and our aim is getting exactly the numbers of these two studies. We expect that
           the COVID-19 patients will be less for two reasons 1) the incidence 2) Trial to treat
           them conservatively outside the hospitals. Nevertheless, even if the numbers are very
           small, we can use non-parametric methods which work even if the groups are less than 20
           and analyzes the ranks and not the crude numbers.

           Ethical Aspects: This an observational study. It will not attempt to change or modify
           the clinical practice of the participating physicians. All surgeons involved in the
           patient's recruitment will be included in the research authorship.

           Methods and assessments:

           Anonimous questionnaire by Google form, sent by mail the surgical departments of
           participant clinical centers identified by a number assigned by the principal
           investigators before starting to enter data.

           The following data will be investigated/recorded/obtained:

           City of the medical institution:

           Country of the medical institution:

           Number assigned:

           Patient Characteristics:

           Gender

             -  Female

             -  Male

             -  Unknown Age (years as numbers)

           Risk factors Malignancy -Yes

             -  No COVID-19 PCR test

             -  Yes

             -  Not performed COVID-19 PCR test

             -  Positive

             -  Negative

             -  Uncertain Immunosuppression (Chronic treatment with glucocorticoids, with
                immunosuppressive agents or chemotherapy, and patients with lymphatic diseases or
                with virus-related immunosuppression such as HIV)

             -  Yes

             -  No Severe cardiovascular disease (Clinical history of ischemic heart disease,
                history of heart failure, severe valvular disease according to ACC/AHA 2007
                Guidelines on Perioperative Cardiovascular Evaluation and Care for Non cardiac
                Surgery)

             -  Yes

             -  No Diabetes mellitus

             -  Clinical history of diabetes

             -  No diabetes

             -  Pre-diabetic (= blood sugar level is higher than it should be but not high enough
                to diagnose diabetes type 2).

             -  Diabetes without organ dysfunction

             -  Diabetes with organ dysfunction

           Severe Chronic kidney disease in preparation for or permanent renal replacement therapy:

             -  Yes

             -  No

           Severe chronic pulmonary disease (clinical history of severe chronic pulmonary disease,
           different from COVID-19 pneumonia):

             -  Yes

             -  No

           Acute Respiratory Distress Syndrome (ARDS):

           -Yes

           -No

           Mechanical Ventilation:

             -  Yes

             -  No

           If yes how many days (numbers)?:

           ....

           Parenteral Nutrition:

             -  Yes

             -  No

           If yes, how many days (as numbers)?:

           …

           Septic shock (Septic shock is defined by persisting hypotension requiring vasopressors
           to maintain a mean arterial pressure of 65 mm Hg or higher and a serum lactate level
           greater than 2 mmol/L (18 mg/dL) despite adequate volume resuscitation):

             -  Yes

             -  No qSOFA score:

           PIPAS severity score:

           …. Physiologic indicators at admission

           Temperature (C):

           …. Systolic blood pressure (mmHg)

           ….. Heart rate (bpm)

           …. Respiratory rate (number of breaths/min)

           ...

           Blood oxygen saturation level (SpO2%):

           ...

           Laboratory parameters at admission WBC (cells/mm³)

           ….. NOT PERFORMED Platelets (cells/mm³) *

           ….. NOT PERFORMED CRP (mg/L) *

           …. NOT PERFORMED ALT (Value = …………….. /units per liter) GGT (Value =………………./units per
           liter) ASAT (Value =………………./units per liter) Procalcitonin (ng/mL)

           ….. NOT PERFORMED Lactate (mmol/L) *

           …. Fibrinogen (g/L)

           .... NOT PERFORMED D-dimer (nmol/L)

           .... NOT PERFORMED Prothrombin time (PT; sec)

           .... NOT PERFORMED Activated partial thromboplastin (aPT; sec)

           .... NOT PERFORMED INR

           .... NOT PERFORMED

           Interleukine 6 (ng/dL):

           …. NOT PERFORMED

           Tromboelastography:

           Normal Increased Maximum Amplitude (MA) Decreased Maximum Amplitude (MA) Increased Lysis
           Index at 30 minutes after MA (LY30) Decreased LY30 Other:….. NOT PERFORMED Diagnosis
           Radiological diagnosis

             -  Ultrasound

             -  Computed Tomography

             -  No radiological diagnosis Abdominal findings

           Localized abdominal pain:

           Yes/No

           Localized abdominal rigidity:

           Yes/No

           Diffuse abdominal pain (more than one abdominal quadrant):

           Yes/No

           Diffuse abdominal rigidity (more than one abdominal quadrant):

           Yes/No

           Delay in ED visit (Number of days from onset of symptoms from ED visit):

           ….

           Murphy Ultrasonography Sign:

             -  Yes

             -  No Pre-operative diagnosis

             -  Lithiasic Cholecystitis

             -  Alithiasic Cholecystitis

             -  Others:…. Gallbladder wall thickness

             -  3-4 mm

             -  4-5 mm

             -  5-6 mm

                ->6 mm Source of infection Peritonitis diffusion

             -  Localized peritonitis/abscess

             -  Diffuse peritonitis Setting of acquisition

             -  Community-acquired

             -  Hospital-acquired

           Treatment:

             -  Laparoscopic intervention in an urgent setting

             -  Laparoscopic intervention in urgent setting+antibiotics

             -  Open cholecystectomy in an urgent setting

             -  Open cholecystectomy in urgent setting+antibiotics

             -  Percutaneous drainage of the gallbladder+antibiotics

             -  Conservative approach (antibiotics alone)

             -  Other:…. Type of intervention:* Total Cholecystectomy in laparoscopy Partial
                Cholecystectomy in laparoscopy Total Cholecystectomy in open technique Total
                cholecystectomy in open technique after conversion Partial cholecystectomy in open
                technique after conversion

           Delay in the surgical/radiology intervention (number of hours):

             -  No Adequate source control

             -  Yes

             -  No Adequate empirical antimicrobial therapy

             -  Yes

             -  No Culture of bile or gallbladder specimen including fungus*

             -  Yes

             -  No (If yes, what the result, main bacteria or yeast…………………………………………..) Detection of
                SARS-CoV-2 in bile

             -  Yes

             -  No

           If yes, it was:

             -  Negative

             -  Positive for SARS-CoV-2

           Detection of SARS-CoV-2 in peri-hepatic fluid:

             -  Yes

             -  No

           If yes, it was:

             -  Negative

             -  Positive Post-operative course (In-hospital) mortality * Yes No Hospital stay
                (days)

           Immediate post-operative complications (By 72 hours)

             -  Localized biliary peritonitis

             -  Diffuse biliary peritonitis

             -  Biliary fistula

             -  Common bile duct injuries

             -  Hollow viscus iatrogenic injury

             -  Bleeding

             -  Postoperative collection

           Early post-operative complications:

             -  Incisional surgical site infection

             -  Eventration

             -  Post-operative peritonitis

             -  Post-operative abdominal abscess

             -  Chest infection NO COMPLICATIONS

           Other:

           Reoperation *

             -  Yes

             -  No

           Reoperation strategy (If reoperation was performed):

             -  Laparoscopy

             -  on demand laparotomy

             -  Planned laparotomy

             -  Radiological intervention Timing of re-operation (If re-operation was performed)
                <24 hours > 24 hours <72 hours Histopathologic findings

             -  Acute cholecistitis

             -  Cholecistitis with necrosis Other diagnosis:…. Safety Considerations There are not
                safety issues

           Informed consent Every patients included in this study will be asked to sign a written
           consent to authorise anonymous treatment of personal data.

           Data Management and Statistical Analysis Every participant investigators is responsible
           for entering data on one Google sheet for every patients included in the study.

           Expected Outcomes of the Study To demonstrate the correlation between necrotic
           cholecystitis and predisposition to thromboembolism in COVID-19 patients.

           Dissemination of Results and Publication Policy The outcomes of this study will be
           analysed and published on a The World Journal of Emergency Surgery in 2021.

           Duration of the Project 1 year

           Ethics This is an observational study: no need for Ethics Committee approval.

           Budget No budget study

           Financing and Insurance Not applicable

           References Bourikian, Seda et al.Risk factors for acute gangrenous cholecystitis in
           emergency general surgery patients. The American Journal of Surgery, Volume 210, Issue
           4, 730 - 733

           Akın Önder, Murat Kapan, Burak Veli Ülger, Abdullah Oğuz, Ahmet Türkoğlu, and Ömer
           Uslukaya (2015) Gangrenous Cholecystitis: Mortality and Risk Factors. Int Surg: February
           2015, Vol. 100, No. 2, pp. 254-260.

           Gomes CA, Soares C, Di Saverio S, Sartelli M, de Souza Silva PG, Orlandi AS, Heringer
           TL, Gomes FC, Catena F. Gangrenous cholecystitis in male patients: A study of prevalence
           and predictive risk factors. Ann Hepatobiliary Pancreat Surg. 2019 Feb;23(1):34-40. doi:
           10.14701/ahbps.2019.23.1.34.

           Contini S, Corradi D, Busi N, Alessandri L, Pezzarossa A, Scarpicnato A. Can gangrenous
           cholecystitis be prevented? A plea against a "wait and see" attitude. J Clin
           Gastroenterol 2004;38(8):710-716

           Eldar S, Eitan A, Bickel A, Sabo E, Cohen A, Abrahamson J et al. The impact of patient
           delay and physician delay on the outcome of laparoscopic cholecystectomy for acute
           cholecystitis. Am J Surg 1999;178(4):303-307

           Pisano M et al.2017 WSES and SICG guidelines on acute calcolous cholecystitis in elderly
           population.World J Emerg Surg. 2019 Mar 4;14:10. doi: 10.1186/s13017-019-0224-7.
           eCollection 2019. Review.

           Hunt DRH, Chu CK. Gangrenous cholecystitis in the laparoscopic era. Aust N Z J Surg
           2000;70(6):428-430

           Edoardo Mattone, Maria Sofia, Elena Schembari et al. Acute acalculous cholecystitis on a
           COVID-19 patient: a case report, 15 July 2020, PREPRINT (Version 1) available at
           Research Square [+https://doi.org/10.21203/rs.3.rs-42230/v1+]

           Ying, M., Lu, B., Pan, J. et al. COVID-19 with acute cholecystitis: a case report. BMC
           Infect Dis 20, 437 (2020). https://doi.org/10.1186/s12879-020-05164-7

           Bruni, A., Garofalo, E., Zuccalà, V. et al. Histopathological findings in a COVID-19
           patient affected by ischemic gangrenous cholecystitis. World J Emerg Surg 15, 43 (2020).
           https://doi.org/10.1186/s13017-020-00320-5

           Campanile, F.C., Podda, M., Arezzo, A. et al. Acute cholecystitis during COVID-19
           pandemic: a multisocietary position statement. World J Emerg Surg 15, 38 (2020).
           https://doi.org/10.1186/s13017-020-00317-0
    


Study Type

Observational [Patient Registry]


Primary Outcome

Risk factors for necrotic cholecystitis in COVID-19 patients


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 2020

Completion Date

September 2021

Primary Completion Date

May 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

, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04542512

Organization ID

06012020


Responsible Party

Principal Investigator

Study Sponsor

Poissy-Saint Germain Hospital


Study Sponsor

, , 


Verification Date

September 2020