Clinical trial NCT06911658: Infectious Complications After Esophagectomy
Official title: Infectious Complications, Associated Factors, and Prognosis After Esophagectomy for Cancer: A French, Multicenter, Retrospective Study - CIFO-study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Esophagectomy
Postoperative Complications
Infections
Pneumonia
Keywords: Postoperative infection
Esophagectomy complications
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients in intensive care unity.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Opposition to the use of data

Primary outcomes:
measure: Incidence of infections after esophagectomy for cancer
timeFrame: until the day 28
Secondary outcomes:
measure: Number of postoperative infectious episodes per participant, classified by anatomical site, as assessed retrospectively from hospitalization records
timeFrame: until the day 28
measure: Presence of predefined pathogens during postoperative infectious episodes, as assessed retrospectively from hospitalization records
timeFrame: until the day 28
measure: Association between preoperative and perioperative clinical variables and the occurrence of postoperative infection, as assessed by multivariable logistic regression analysis of hospitalization records
timeFrame: until the day 28
measure: 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
timeFrame: until day 28
measure: Association between postoperative infection and length of hospital stay, as assessed by linear regression analysis of hospitalization records
timeFrame: until day 28
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint Louis Hospital
Study officials:
affiliation: APHP
name: François DEPRET, MD-PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP
name: DEPRET
role: PRINCIPAL_INVESTIGATOR
References: