Cholecystitis, AcuteChoCO-WNCT04542512
Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic.
An observational study of Cholecystitis, Acute and Cholecystitis; Gangrenous, run by Poissy-Saint Germain Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cholecystitis, Acute, Cholecystitis; Gangrenous, Cholecystitis Suppurative
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to Dec 2021
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the surgical department with clinical and histologic diagnosis of acute cholecystitis (with and without gangrenous cholecystitis).
Who may be able to join
- All patients presenting acute cholecystitis during COVID 19 pandemic, aged >=18 yo
Who cannot join
- Patients presenting with acute cholecystitis aged <18 yo
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Intercommunal Poissy-Saint Germain en Laye
Poissy, 73082
Belinda De Simone, MD, desimone.belinda@gmail.com
Belinda De Simone, MD
About this study
Official title: Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic: the ChoCO-WSES Prospective Observational Multicenter International Study.
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.
Read the 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
- Keywords
- COVID-19, emergency surgery, acute abdomen, peritonitis, cholecystitis, necrotic cholecystitis, percutaneous drainage of gallbladder, laparoscopic cholecystectomy, operative management, timing of cholecystectomy
- Medical subject headings
- Cholecystitis, Acute, Cholecystitis, Gangrene, COVID-19, Abdomen, Acute, Peritonitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between COVID-19 pneumonia and necrotic cholecystitis
Incidence of necrotic cholecystitis in COVID-19 patients
Measured: through study completion, an average of 1 year
Correlation between coagulopathy and necrotic cholecystitis
mortality related to necrotising cholecystitis in COVID-19 patients
Measured: through study completion, an average of 1 year
Outcome necrotic cholecystitis during COVID-19 pandemic
overall mortality
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Correlation between coagulopathy and necrotic cholecystitis
D-Dimer value
Measured: through study completion, an average of 1 year
Risk factors for necrotic cholecystitis
COVID-19 infection
Measured: through study completion, an average of 1 year
Correlation between coagulopathy and necrotic cholecystitis
Mean INR value
Measured: through study completion, an average of 1 year
Correlation between coagulopathy and necrotic cholecystitis
Mean Prothrombin time (PT; sec); mean activated partial thromboplastin (aPT; sec)
Measured: through study completion, an average of 1 year
Correlation between coagulopathy and necrotic cholecystitis
Mean Fibrinogen value (g/L)
Measured: through study completion, an average of 1 year
Correlation between coagulopathy and necrotic cholecystitis
most common alterations of thromboelastography
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Poissy-Saint Germain Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- World Society of Emergency Surgery, Intercontinental society of Natural Orifice, Endoscopic, and Laparoscopic Surgery
- Responsible party
- Principal investigator, Belinda De Simone, Poissy-Saint Germain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542512
- Sponsor's protocol ID
- 06012020
- Acronym
- ChoCO-W
- Status last verified
- Mar 2021
- First submitted
- 6 Sep 2020
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eldar S, Eitan A, Bickel A, Sabo E, Cohen A, Abrahamson J, Matter I. The impact of patient delay and physician delay on the outcome of laparoscopic cholecystectomy for acute cholecystitis. Am J Surg. 1999 Oct;178(4):303-7. doi: 10.1016/s0002-9610(99)00172-5.
PubMed 10587188Ying M, Lu B, Pan J, Lu G, Zhou S, Wang D, Li L, Shen J, Shu J; From the COVID-19 Investigating and Research Team. COVID-19 with acute cholecystitis: a case report. BMC Infect Dis. 2020 Jun 22;20(1):437. doi: 10.1186/s12879-020-05164-7.
PubMed 32571224Bruni A, Garofalo E, Zuccala V, Curro G, Torti C, Navarra G, De Sarro G, Navalesi P, Longhini F, Ammendola M. Histopathological findings in a COVID-19 patient affected by ischemic gangrenous cholecystitis. World J Emerg Surg. 2020 Jul 2;15(1):43. doi: 10.1186/s13017-020-00320-5.
PubMed 32615987Campanile FC, Podda M, Arezzo A, Botteri E, Sartori A, Guerrieri M, Cassinotti E, Muttillo I, Pisano M, Brachet Contul R, D'Ambrosio G, Cuccurullo D, Bergamini C, Allaix ME, Caracino V, Petz WL, Milone M, Silecchia G, Anania G, Agrusa A, Di Saverio S, Casarano S, Cicala C, Narilli P, Federici S, Carlini M, Paganini A, Bianchi PP, Salaj A, Mazzari A, Meniconi RL, Puzziello A, Terrosu G, De Simone B, Coccolini F, Catena F, Agresta F. Acute cholecystitis during COVID-19 pandemic: a multisocietary position statement. World J Emerg Surg. 2020 Jun 8;15(1):38. doi: 10.1186/s13017-020-00317-0.
PubMed 32513287Bourikian S, Anand RJ, Aboutanos M, Wolfe LG, Ferrada P. Risk factors for acute gangrenous cholecystitis in emergency general surgery patients. Am J Surg. 2015 Oct;210(4):730-3. doi: 10.1016/j.amjsurg.2015.05.003. Epub 2015 Jun 27.
PubMed 26186803Onder A, Kapan M, Ulger BV, Oguz A, Turkoglu A, Uslukaya O. Gangrenous cholecystitis: mortality and risk factors. Int Surg. 2015 Feb;100(2):254-60. doi: 10.9738/INTSURG-D-13-00222.1.
PubMed 25692427Gomes 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. Epub 2019 Feb 28.
PubMed 30863805Contini S, Corradi D, Busi N, Alessandri L, Pezzarossa A, Scarpignato C. Can gangrenous cholecystitis be prevented?: a plea against a "wait and see" attitude. J Clin Gastroenterol. 2004 Sep;38(8):710-6. doi: 10.1097/01.mcg.0000135898.68155.88.
PubMed 15319657Pisano M, Ceresoli M, Cimbanassi S, Gurusamy K, Coccolini F, Borzellino G, Costa G, Allievi N, Amato B, Boerma D, Calcagno P, Campanati L, Campanile FC, Casati A, Chiara O, Crucitti A, di Saverio S, Filauro M, Gabrielli F, Guttadauro A, Kluger Y, Magnone S, Merli C, Poiasina E, Puzziello A, Sartelli M, Catena F, Ansaloni L. 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.
PubMed 30867674Hunt DR, Chu FC. Gangrenous cholecystitis in the laparoscopic era. Aust N Z J Surg. 2000 Jun;70(6):428-30. doi: 10.1046/j.1440-1622.2000.01851.x.
PubMed 10843398
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic: the ChoCO-WSES Prospective Observational Multicenter International Study.
- ClinicalTrials.gov ID
- NCT04542512
- Acronym / sponsor ID
- ChoCO-W / 06012020
- Keywords
- COVID-19, emergency surgery, acute abdomen, peritonitis, cholecystitis, necrotic cholecystitis, percutaneous drainage of gallbladder, laparoscopic cholecystectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Poissy-Saint Germain HospitalUniversity, hospital or other
- Collaborators
- World Society of Emergency Surgery, Intercontinental society of Natural Orifice, Endoscopic, and Laparoscopic Surgery
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Months
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the surgical department with clinical and histologic diagnosis of acute cholecystitis (with and without gangrenous cholecystitis).
Key inclusion criteria (1 listed)
- All patients presenting acute cholecystitis during COVID 19 pandemic, aged >=18 yo
Key exclusion criteria (1 listed)
- Patients presenting with acute cholecystitis aged <18 yo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between COVID-19 pneumonia and necrotic cholecystitis
Time frame: through study completion, an average of 1 year
Incidence of necrotic cholecystitis in COVID-19 patients
Correlation between coagulopathy and necrotic cholecystitis
Time frame: through study completion, an average of 1 year
mortality related to necrotising cholecystitis in COVID-19 patients
Outcome necrotic cholecystitis during COVID-19 pandemic
Time frame: through study completion, an average of 1 year
overall mortality
6 secondary outcomes
Correlation between coagulopathy and necrotic cholecystitis
Time frame: through study completion, an average of 1 year
Risk factors for necrotic cholecystitis
Time frame: through study completion, an average of 1 year
Correlation between coagulopathy and necrotic cholecystitis
Time frame: through study completion, an average of 1 year
Correlation between coagulopathy and necrotic cholecystitis
Time frame: through study completion, an average of 1 year
Correlation between coagulopathy and necrotic cholecystitis
Time frame: through study completion, an average of 1 year
Correlation between coagulopathy and necrotic cholecystitis
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Background: PubMed 10587188Eldar S, Eitan A, Bickel A, Sabo E, Cohen A, Abrahamson J, Matter I. The impact of patient delay and physician delay on the outcome of laparoscopic cholecystectomy for acute cholecystitis. Am J Surg. 1999 Oct;178(4):303-7. doi: 10.1016/s0002-9610(99)00172-5.
- Background: PubMed 32571224Ying M, Lu B, Pan J, Lu G, Zhou S, Wang D, Li L, Shen J, Shu J; From the COVID-19 Investigating and Research Team. COVID-19 with acute cholecystitis: a case report. BMC Infect Dis. 2020 Jun 22;20(1):437. doi: 10.1186/s12879-020-05164-7.
- Background: PubMed 32615987Bruni A, Garofalo E, Zuccala V, Curro G, Torti C, Navarra G, De Sarro G, Navalesi P, Longhini F, Ammendola M. Histopathological findings in a COVID-19 patient affected by ischemic gangrenous cholecystitis. World J Emerg Surg. 2020 Jul 2;15(1):43. doi: 10.1186/s13017-020-00320-5.
- Background: PubMed 32513287Campanile FC, Podda M, Arezzo A, Botteri E, Sartori A, Guerrieri M, Cassinotti E, Muttillo I, Pisano M, Brachet Contul R, D'Ambrosio G, Cuccurullo D, Bergamini C, Allaix ME, Caracino V, Petz WL, Milone M, Silecchia G, Anania G, Agrusa A, Di Saverio S, Casarano S, Cicala C, Narilli P, Federici S, Carlini M, Paganini A, Bianchi PP, Salaj A, Mazzari A, Meniconi RL, Puzziello A, Terrosu G, De Simone B, Coccolini F, Catena F, Agresta F. Acute cholecystitis during COVID-19 pandemic: a multisocietary position statement. World J Emerg Surg. 2020 Jun 8;15(1):38. doi: 10.1186/s13017-020-00317-0.
- Results publication: PubMed 26186803Bourikian S, Anand RJ, Aboutanos M, Wolfe LG, Ferrada P. Risk factors for acute gangrenous cholecystitis in emergency general surgery patients. Am J Surg. 2015 Oct;210(4):730-3. doi: 10.1016/j.amjsurg.2015.05.003. Epub 2015 Jun 27.
- Results publication: PubMed 25692427Onder A, Kapan M, Ulger BV, Oguz A, Turkoglu A, Uslukaya O. Gangrenous cholecystitis: mortality and risk factors. Int Surg. 2015 Feb;100(2):254-60. doi: 10.9738/INTSURG-D-13-00222.1.
- Results publication: PubMed 30863805Gomes 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. Epub 2019 Feb 28.
- Results publication: PubMed 15319657Contini S, Corradi D, Busi N, Alessandri L, Pezzarossa A, Scarpignato C. Can gangrenous cholecystitis be prevented?: a plea against a "wait and see" attitude. J Clin Gastroenterol. 2004 Sep;38(8):710-6. doi: 10.1097/01.mcg.0000135898.68155.88.
- Results publication: PubMed 30867674Pisano M, Ceresoli M, Cimbanassi S, Gurusamy K, Coccolini F, Borzellino G, Costa G, Allievi N, Amato B, Boerma D, Calcagno P, Campanati L, Campanile FC, Casati A, Chiara O, Crucitti A, di Saverio S, Filauro M, Gabrielli F, Guttadauro A, Kluger Y, Magnone S, Merli C, Poiasina E, Puzziello A, Sartelli M, Catena F, Ansaloni L. 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.
- Results publication: PubMed 10843398Hunt DR, Chu FC. Gangrenous cholecystitis in the laparoscopic era. Aust N Z J Surg. 2000 Jun;70(6):428-30. doi: 10.1046/j.1440-1622.2000.01851.x.
- Registration form to collaborateLink provided by the sponsor.
- Online case report formLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Cholecystitis, Acute
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
Cholecystitis, Acute, Biliary Diseases
Not yet recruiting
Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy
Cholecystitis, Acute, Cholecystectomy, Laparoscopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis, Acute and Cholecystitis; Gangrenous, run by Poissy-Saint Germain Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Belinda De Simone, MD (+33665787872, desimone.belinda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between COVID-19 pneumonia and necrotic cholecystitis (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04542512, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.