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

Learn more about:
Related Clinical Trial
GB34 Acupuncture in Acute Cholecystitis Low Dose ICG for Biliary Tract and Tumor Imaging Visualization of the Extrahepatic biliaRy Tree Trial Gallbladder Cryoablation in High-Risk Patients Hong Kong Follow up Protocol After EUS Gallbladder Drainage for Acute Cholecistitis Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case. Naldebain for Pain Management of Laparoscopic Cholecystectomy Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate Necessity of Preoperative Empirical Antibiotic Use in Acute Cholecystitis Safety and Feasibility of ActivSightTM in Human Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: A Retrospective Study. A Scoring System for Difficult Laparoscopic Cholecystectomy RISK FACTORS FOR NECROTIC CHOLECYSTITIS DURING COVID-19 PANDEMIC: THE ChoCO WSES PROSPECTIVE MULTICENTER OBSERVATIONAL STUDY Evaluation of a Protocol for Multidisciplinary Management of Acute Cholecystitis. How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis Prognostic Indicators as Provided by the EPIC ClearView WSES International Register of Emergency Surgery Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections. Prospective Validation of “Cholecystectomy First” Strategy for Gallstone Migration ONSD According to the Position During Laparoscopy Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy Drainage or Not for Laparoscopic Cholecystetomy UDCA for Symptomatic Gallstone Disease Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Transvaginal Cholecystectomy Using Endoscopic Assistance Doripenem in the Treatment of Complicated Intra-Abdominal Infections Doripenem in the Treatment of Complicated Intra-Abdominal Infections The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy Evaluation of PC 6 “Neiguan” With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy. Role of the Right Portal Pedicle and Rouviere’s Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection. NOTES-Assisted Laparoscopic Cholecystectomy Surgery EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy Fluorescence Cholangiography During Cholecystectomy – a RCT Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA FALCON: a Multicenter Randomized Controlled Trial Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy 3D Versus 4K Laparoscopic Cholecystectomy Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy Effect of Modified Stylet Angulation on the Intubation With GlideScope® Evaluation of Closed-loop TIVA Propofol, Sufentanil and Ketamine Guided by BIS Monitor BDD With UDCA Therapy After Laparoscopic Cholecystectomy Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy Postoperative Pain Results According to Pressure to Form Pneumoperitoneum Benefits of Glycopyrrolate on Intubation With Rigid-videostylet (OptiScope®) Prediction of Postoperative Pain by Injection Pain of Propofol Transient ECG Changes in Patients With Acute Biliary Disease Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy Establishing Visualization Grading Scale on LESS Cholecystectomy Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy A Clinical Study of Chinese Domestic Surgical Robot Laparoscopic Cholecystectomy: Study of Left Side of Laparoscopic Cholecystectomy Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Effects of Drainage in Laparoscopic Cholecystectomy Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy Study of Pain Perception Between Males and Females Following Laparoscopic Cholecystectomy Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis Comparison of Morbidity After Laparoscopic Cholecystectomy for Acutely Inflamed Gall Bladder With and Without Drain Early Versus Delayed Cholecystectomy If Chronic Gallbladder Diseases Increase the Incidence of PEC Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery Use of Robotics for Cholecystectomy; Retrospective Review of Outcomes, Set Up and Learning Curves Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy — Use in Acute Cholecystitis Sub-Study The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy Enhanced Recovery in Laparoscopic Cholecystectomy Empirical Antibiotics in Acute Inflammatory Gallbladder Disease Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement. Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms Bile Aspiration vs Drain in Acute Cholecystitis Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis Fluorescent Cholangiography During Acute Cholecystitis Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis Trial Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder? Percutaneous Transhepatic Cholangiography (PTHC) in Acute Cholecystitis and Clinical Outcomes Acute Cholecystitis – Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy Scoring System in Acute Calculous Cholecystitis Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? Fast Track Pathway to Accelerated Cholecystectomy Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA) Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study. Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis. Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis The Role of Ultrasound in Cholecystitis AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis The Real World of Acute Cholecystitis Functional MRC With Eovist for Acute Cholecystitis FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis

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 Observational Multicenter International 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 and
      their management.
    

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 study aims to evaluate the incidence and mortality of necrotic cholecystitis among Covid
      (+) patients under the COVID-19 pandemic, to improve their management and to confirm that
      COVID-19 infection is a risk factor for necrotic cholecystitis; to assess the management of
      acute cholecystitis during COVID-19 pandemic.

      The rationale for the trial:

        -  Investigate the risk factors to develop necrotic cholecystitis under the COVID-19
           pandemic;

        -  Evaluate the management of acute cholecystitis focusing on treatments and outcomes of
           the operative or non-operative management in COVID (+) and COVID (-) patients to improve
           outcomes, decreasing morbidity and mortality rates related to emergency setting and
           high-risk patients;

        -  Confirm that COVID-19 disease is a risk factor for necrotic cholecystitis.

      Objectives:

      Evaluate the incidence of necrotic cholecystitis during the COVID-19 pandemic among Covid
      patients; Evaluate the prevalence of necrotic cholecystitis in patients presenting with acute
      cholecystitis during the COVID-19 pandemic; Evaluate the risk factors for necrotic
      cholecystitis in COVID-19 patients and negative ones.

      Confirm the hypothesis that COVID-19 infection is a risk factor for necrotic cholecystitis;
      Evaluate the clinical outcomes of early (<72h from the onset of symptoms) versus delayed
      (>72h from the onset of symptoms) cholecystectomy, and of a non operative management
      according to the WSES international guidelines (2020) for the management of calculus
      cholecystitis and Tokyo severity classification for cholecystitis, in terms of mortality and
      morbidity.

      Primary endpoints To evaluate the prevalence of necrotic cholecystitis among patients
      admitted for acute cholecystitis during the Covid-19 pandemic; The incidence of necrotizing
      cholecystitis in the cohort of COVID-19 positive patients; To assess mortality due to
      necrotic cholecystitis during the Covid-19 pandemic among Covid-19 infected patients

      Secondary endpoints To investigate the risk factors for necrotic cholecystitis in patients
      admitted with diagnosis of acute cholecystitis and in the cohort of Covid-19 patients; to
      investigate if the COVID-19 infection is a risk factor to present necrotic cholecystitis; to
      assess the management of acute cholecystitis during Covid-19 pandemic and the role of non
      operative management strategy and operative management.

      Study Design:

      International Observational Prospective Cohort Study.

      Study population:

      All adult patients admitted to the surgical department with a diagnosis of acute
      cholecystitis (with and without necrotising cholecystitis).

      Inclusion criteria Patients of all age and sex admitted in the emergency department for acute
      cholecystitis, aged >=18 years old.

      Exclusion criteria Patients aged< 18 years old.

      Period April 2021-September 2021

      Data collection All epidemiological, clinical, surgical and follow up data will be collected
      on an online case report form.

      Sample size calculation This is an explorative study and data will be used to investigate
      risk factors, prevalence of necrotic cholecystitis among patients admitted with diagnosis of
      acute cholecystitis during COVID-19 pandemic, and the specific characteristics behind the
      choice between early cholecystectomy, delayed cholecystectomy, radiological drainage of the
      gallbladder and medical treatment (antibiotics) in an emergency setting.

      We calculated the sample size by considering the incidence of necrotic cholecystitis reported
      in literature which corresponds to a range of 2-30%. Taking into account the mean between the
      2 values, and in the lack of data on the incidence of necrotic cholecystitis in Covid
      patients, that we assumed to be double the incidence of necrotic cholecystitis in non-Covid
      population, with an alfa risk estimated error equal to 0.05, the study population will be
      composed of 2 cohorts of 111 patients

      Statistical analysis This is a study evaluating the prevalence of necrotic cholecystitis
      among patients admitted for acute cholecystitis during COVID-19 pandemic and the incidence of
      necrotic cholecystitis in Covid (+) patients. An univariate and multivariate analysis of each
      scheduled parameter will be carried out. In the statistical analysis, the investigator will
      differentiate data by cohorts (Covid (-) and Covid (+) patients) and gender. The main aim of
      this study is to assess the management of all patients having acute cholecystitis during
      COVID-19.

      Primary endpoints:

      In hospital mortality among patients with acute necrotic cholecystitis In hospital mortality
      among Covid-19 patients presenting with acute necrotic cholecystitis

      Secondary endpoints To assess the risk factors for necrotic cholecystitis in Covid+ patients;
      To evaluate the management of acute cholecystitis during the Covid-19 pandemic (medical
      treatment, surgical treatment, medical treatment and radiological drainage of the
      gallbladder); To confirm that COVID-19 infection is a risk factor for developing necrotic
      cholecystitis.

      Ethical Aspects This is 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. 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 centre attending the study is responsible for Ethics Committee approval.

      All surgeons involved in the patients' recruitment will be included in the research
      authorship.

      Methods and assessments:

      Every clinical centre will be identified by a number assigned by the principal investigator
      before starting data entry. An online case report form will be available to collect data: the
      link for the access will be sent to the local investigator, to share with local
      collaborators.

      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. Each eligible patient for this study will be asked to sign a written consent to
      authorize the anonymous treatment of personal data, according to standard clinical practice.

      Data Management and Statistical Analysis Every local investigator is responsible for data
      entry. Prof. Fikri Abu-Zidan is the coordinator of statistical analysis.

      Expected Outcomes of the Study The aim of this study is to demonstrate the the correlation
      between necrotic cholecystitis and predisposition to thrombo-embolism in COVID-19 patients
      and that the patients presenting one or more risk factors for necrotic cholecystitis have to
      be managed operatively without long delay if fit for surgery.

      Dissemination of Results and Publication Policy The primary outcomes of the study will be
      presented at the World Congress of the World Society of Emergency Surgery in September 2021.
      The ChoCO-W study embraces corporate authorship and all collaborators that contribute to this
      study will form the ChoCO-W collaborative group. This group will co-author all publications
      in which ChoCO-W study data is used.

      Duration of the Project 2 years

      Ethics This is an observational study.

      Budget No budget study

      Financing and Insurance Not applicable
    


Study Type

Observational [Patient Registry]


Primary Outcome

Correlation between COVID-19 pneumonia and necrotic cholecystitis

Secondary Outcome

 Correlation between coagulopathy 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

December 2021

Primary Completion Date

September 30, 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

March 2021