Infectious Complications After Esophagectomy

NCT06911658 | Recruiting

• 1 other identifier: APHP250038
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 2

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.

Conditions

Esophagectomy; Postoperative Complications; Infections; Pneumonia

Keywords

Postoperative infection; Esophagectomy complications

Outcome Measures

Primary Outcomes (1)

• Incidence of infections after esophagectomy for cancer

  until the day 28

Secondary Outcomes (5)

• Number of postoperative infectious episodes per participant, classified by anatomical site, as assessed retrospectively from hospitalization records

  until the day 28

• Presence of predefined pathogens during postoperative infectious episodes, as assessed retrospectively from hospitalization records

  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

  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

  until day 28

• Association between postoperative infection and length of hospital stay, as assessed by linear regression analysis of hospitalization records

  until day 28

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients in intensive care unity.

You may qualify if:

• 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

You may not qualify if:

• Opposition to the use of data

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Saint-Louis - APHP

Paris, 75010, France

RECRUITING

Saint Louis Hospital

Paris, 75010, France

NOT YET RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Infections; Pneumonia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• François DEPRET, MD-PHD

  APHP

  PRINCIPAL INVESTIGATOR

• DEPRET

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François DEPRET, MD-PHD

CONTACT

0142499570; francois.depret@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 4, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): July 28, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)