EsophagectomyCIFONCT06911658
Infectious Complications After Esophagectomy
An observational study of Esophagectomy and Postoperative Complications, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Infectious complications represent the most common postoperative adverse events following esophagectomy for cancer, such as pneumonia (15% of cases). These complications increase immediate risks, lengthen hospital stays, and worsen patient quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagectomy, Postoperative Complications, Infections
- How many people
- 1,029 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Aug 2025to 4 Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients in intensive care unity.
Who may be able to join
- Patients over 18 years of age
- Underwent esophagectomy for cancer between January 1, 2017, and December 31, 2024
- Scheduled admission to intensive care for postoperative monitoring
Who cannot join
- Opposition to the use of data
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Saint-Louis - APHP
Paris, 75010
Saint Louis Hospital
Paris, 75010
About this study
Official title: Infectious Complications, Associated Factors, and Prognosis After Esophagectomy for Cancer: A French, Multicenter, Retrospective Study - CIFO-study
Infectious complications represent the most common postoperative adverse events following esophagectomy for cancer, such as pneumonia (15% of cases). These complications increase immediate risks, lengthen hospital stays, and worsen patient quality of life.
The population includes patients admitted to intensive care after esophagectomy for cancer between January 1, 2017, and December 31, 2024.
Read more
The study focuses on this population due to the increasing incidence of esophageal cancer, the increased use of surgery for these indications, and the importance of postoperative infections in these complex procedures, despite their understudied nature in the current literature. Identifying modifiable risk factors could lead to corrective measures and thus improve the prognosis of postoperative patients.
The research focuses primarily on the incidence, types, factors, and prognosis associated with the occurrence of infections after esophagectomy for cancer. It also includes an analysis of the pathogens involved, their resistance profiles, and the antibiotic therapies used in first-line probabilistic treatment.
Read the detailed description
The retrospective, multicenter study consists of the retrospective and pseudonymous collection of data from the medical reports of patients, covering the period from January 2017 to December 31, 2024, who were treated in each participating intensive care unit.
The investigators at each participating center will be responsible for screening and including patients, as well as obtaining their non-opposition.
Patients who were hospitalized for esophagectomy will be included, provided there are no exclusion criteria.
The following data will be collected after pseudonymization: only the first letter of the patient's last name and the first letter of their first name will be recorded, along with a study-specific coded number, which will differ for each center and indicate the order of inclusion of subjects. A correspondence table will be kept at each center for a period of 15 years. This table will be stored within each participating center.
At each participating center, data entry will be coordinated by the investigator responsible for the center. The collected data will be pseudonymized and stored in a secure database located at each participating center.
- If the patient is alive: the patient will be informed about the study. Data collection will begin only after the patient has been informed and only if the patient does not express opposition to the use of their data.
- If the patient is deceased and the vital status of the patient is known to the investigator: in this case, the investigator will verify in the patient's medical record that the patient has never expressed written opposition to the use of their data for research purposes. If the patient has never objected, their data will be collected.
- Conditions
- Esophagectomy, Postoperative Complications, Infections, Pneumonia
- Keywords
- Postoperative infection, Esophagectomy complications
- Medical subject headings
- Postoperative Complications, Infections, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infections after esophagectomy for cancer
Measured: until the day 28
Secondary outcomes (5)
Number of postoperative infectious episodes per participant, classified by anatomical site, as assessed retrospectively from hospitalization records
Each infectious episode occurring within 28 days after esophagectomy will be retrospectively identified by review of hospitalization records. The anatomical site of infection (e.g., pulmonary, pleural, mediastinal, urinary, abdominal, surgical wound, bloodstream) will be determined based on the description found in medical documentation.
The diagnosis of infection will rely on retrospective analysis of recorded clinical signs (e.g., fever), laboratory data (e.g., leukocytosis, elevated CRP), imaging reports (e.g., CT scan, chest X-ray), and physician assessmentsdocumented in the medical file.
The unit of measure is : number of infectious episodes per participant. The data will be reported as the total number of episodes and their distribution by anatomical site, summarized per participant and overall using descriptive statistics (median [IQR], counts, percentages).
Measured: until the day 28
Presence of predefined pathogens during postoperative infectious episodes, as assessed retrospectively from hospitalization records
For each postoperative infectious episode occurring within 28 days after esophagectomy, the presence or absence of specific pathogens will be retrospectively extracted from hospitalization reports using a structured checklist.
The pathogens are not recorded as free-text entries but as binary variables (Yes/No) based on the presence of documentation in medical reports (microbiology results, discharge summaries, etc.).
The predefined list includes :
- Gram-positive cocci : Streptococcus spp., Enterococcus spp., E. faecium, Staphylococcus aureus (including MRSA)
- Gram-negative bacteria : Haemophilus spp., Enterobacteriaceae (groups 1-3), non-fermenting bacilli (P. aeruginosa, A. baumannii, S. maltophilia)
- Resistance profiles : ESBL-producing Enterobacteriaceae, carbapenemase-producing organisms
- Fungi : Yeasts
- Polymicrobial vs. monomicrobial infections Only pathogens explicitly mentioned in the clinical documentation (culture or PCR results) are recorded. The data are collected usi
Measured: until the day 28
Association between preoperative and perioperative clinical variables and the occurrence of postoperative infection, as assessed by multivariable logistic regression analysis of hospitalization records
This outcome aims to explore the association between clinical and surgical factors and the risk of developing at least one infectious episode within 28 days following esophagectomy.
Postoperative infections will be identified retrospectively based on hospitalization records. A multivariable logistic regression analysis will be conducted, with infection occurrence (Yes/No) as the dependent variable.
Covariates will include :
- Demographic characteristics : age and sex
- Lifestyle factors : tobacco use and alcohol consumption (>2 drinks/day)
- Nutritional status and general severity : Body Mass Index (BMI), IGS2 score at ICU admission
- Comorbidities : cardiovascular disease (hypertension, myocardial infarction, congestive heart failure), chronic pulmonary disease, cerebrovascular disease (including stroke or transient ischemic attack), peripheral vascular disease (including aortic aneurysm >6 cm), diabetes (complicated or not), renal failure, liver disease (moderate or severe), dementi
Measured: until the day 28
Occurrence of major complications (sepsis, septic shock, AKI, ARDS, or death) within 28 days after esophagectomy, as documented in hospitalization records, compared between infected and non-infected patients
Association between postoperative infection and the occurrence of major complications (sepsis, septic shock, AKI, ARDS, or death), as assessed by logistic regression analyses of hospitalization records.
Description
This outcome assesses the relationship between the occurrence of postoperative infection (within 28 days of esophagectomy) and the development of the following complications :
- Sepsis (according to Sepsis-3)
- Septic shock (according to Sepsis-3)
- Acute kidney injury (AKI according to KDIGO)
- Acute respiratory distress syndrome (ARDS according to the Berlin's definition)
- Mortality All events will be collected retrospectively from hospitalization records. A logistic regression will be used for each outcome separately to estimate the effect of infection (Yes/No) on the likelihood of each complication.
Unit of measure : Odds Ratio (OR) with 95% Confidence Interval for each complication
Measured: until day 28
Association between postoperative infection and length of hospital stay, as assessed by linear regression analysis of hospitalization records
Length of hospital stay (in days, from surgery to discharge) will be extracted from hospitalization records.
A linear regression model will be used to assess whether the occurrence of a postoperative infection is associated with a prolonged hospital stay, adjusted for relevant covariates.
Unit of measure : Median difference in number of days, with 95% Confidence Interval
Measured: until day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start27 Aug 2025
- Primary completion4 Sep 2026
- Study completion4 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagectomyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François DEPRET, MD-PHD, Principal investigator, APHPDEPRET, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911658
- Sponsor's protocol ID
- APHP250038
- Acronym
- CIFO
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infectious Complications, Associated Factors, and Prognosis After Esophagectomy for Cancer: A French, Multicenter, Retrospective Study - CIFO-study
- ClinicalTrials.gov ID
- NCT06911658
- Acronym / sponsor ID
- CIFO / APHP250038
- Conditions
- Esophagectomy, Postoperative Complications, Infections, Pneumonia
- Keywords
- Postoperative infection, Esophagectomy complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 4 Sep 2026 (actual)
- Study completion
- 4 Sep 2026 (actual)
- First posted
- 4 Apr 2025 (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.
Infectious complications represent the most common postoperative adverse events following esophagectomy for cancer, such as pneumonia (15% of cases). These complications increase immediate risks, lengthen hospital stays, and worsen patient quality of life.
The population includes patients admitted to intensive care after esophagectomy for cancer between January 1, 2017, and December 31, 2024.
The study focuses on this population due to the increasing incidence of esophageal cancer, the increased use of surgery for these indications, and the importance of postoperative infections in these complex procedures, despite their understudied nature in the current literature. Identifying modifiable risk factors could lead to corrective measures and thus improve the prognosis of postoperative patients.
The research focuses primarily on the incidence, types, factors, and prognosis associated with the occurrence of infections after esophagectomy for cancer. It also includes an analysis of the pathogens involved, their resistance profiles, and the antibiotic therapies used in first-line probabilistic treatment.
Detailed description
The retrospective, multicenter study consists of the retrospective and pseudonymous collection of data from the medical reports of patients, covering the period from January 2017 to December 31, 2024, who were treated in each participating intensive care unit.
The investigators at each participating center will be responsible for screening and including patients, as well as obtaining their non-opposition.
Patients who were hospitalized for esophagectomy will be included, provided there are no exclusion criteria.
The following data will be collected after pseudonymization: only the first letter of the patient's last name and the first letter of their first name will be recorded, along with a study-specific coded number, which will differ for each center and indicate the order of inclusion of subjects. A correspondence table will be kept at each center for a period of 15 years. This table will be stored within each participating center.
At each participating center, data entry will be coordinated by the investigator responsible for the center. The collected data will be pseudonymized and stored in a secure database located at each participating center.
- If the patient is alive: the patient will be informed about the study. Data collection will begin only after the patient has been informed and only if the patient does not express opposition to the use of their data.
- If the patient is deceased and the vital status of the patient is known to the investigator: in this case, the investigator will verify in the patient's medical record that the patient has never expressed written opposition to the use of their data for research purposes. If the patient has never objected, their data will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients in intensive care unity.
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Underwent esophagectomy for cancer between January 1, 2017, and December 31, 2024
- Scheduled admission to intensive care for postoperative monitoring
Key exclusion criteria (1 listed)
- Opposition to the use of data
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
Incidence of infections after esophagectomy for cancer
Time frame: until the day 28
5 secondary outcomes
Number of postoperative infectious episodes per participant, classified by anatomical site, as assessed retrospectively from hospitalization records
Time frame: until the day 28
Presence of predefined pathogens during postoperative infectious episodes, as assessed retrospectively from hospitalization records
Time frame: until the day 28
Association between preoperative and perioperative clinical variables and the occurrence of postoperative infection, as assessed by multivariable logistic regression analysis of hospitalization records
Time frame: until the day 28
Occurrence of major complications (sepsis, septic shock, AKI, ARDS, or death) within 28 days after esophagectomy, as documented in hospitalization records, compared between infected and non-infected patients
Time frame: until day 28
Association between postoperative infection and length of hospital stay, as assessed by linear regression analysis of hospitalization records
Time frame: until day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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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.
François DEPRET, MD-PHD principal investigator
APHP
DEPRET principal investigator
APHP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagectomy and Postoperative Complications, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 3 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infections after esophagectomy for cancer (time frame: until the day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.