Clinical trial NCT06513598: Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it
Official title: New Studies of the Pathogenesis of Postoperative Infections and Development of Biomarkers for Early Diagnosis of Postoperative Complications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complication of Surgical Procedure
Infections
Keywords: microbiota
surgical oncology
gastrointestinal cancer
postoperative complications
biomarkers
Lead sponsor: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Sponsor class: OTHER
Collaborators: name: Vilnius University Hospital Santaros Klinikos
First posted: 2024-07-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo major abdominal surgery due to the cancer of the esophagus, stomach, pancreas, liver, bile ducts, colon, or rectum due to cancer will be eligible to participate.

Brief summary: Infections remain a prevalent complication after major abdominal surgery. The common belief that most surgical site infections (SSIs) following elective surgery with modern antiseptic techniques are due to intraoperative contamination is still not confirmed. Therefore, alternative mechanisms for SSI development, such as the Trojan Horse theory-which suggests that pathogens from distant sites like the gastrointestinal tract may cause postoperative infections-should be explored. This study aims to analyze the preoperative microbiome of surgical patients' gut and oral cavities and assess whether microorganisms found there are present at the infection site. Additionally, this study will investigate a panel of biomarkers for predicting postoperative infections.

Detailed description: Infections remain a significant concern following major abdominal surgery. The prevailing notion that most surgical site infections (SSIs) after elective surgery with modern antiseptic techniques are solely caused by intraoperative contamination remains unconfirmed. Therefore, alternative mechanisms for SSI development, such as the Trojan Horse theory-which suggests that pathogens from distant sites like the gastrointestinal tract may contribute to postoperative infections-require thorough investigation. This longitudinal observational study aims to either support or challenge the Trojan Horse theory.

This study will enroll patients undergoing major abdominal surgery for confirmed or suspected cancer. Biological samples from stool, the oral cavity, and infection sites will be collected for sequencing and microbiome analysis to evaluate the presence of pathogens potentially responsible for postoperative infections originating from the gastrointestinal tract. Additionally, blood samples will be collected to identify predictive biomarkers associated with the development of postoperative infections.

Eligibility criteria: Inclusion Criteria:

1. The patient is scheduled to undergo a major resection-type abdominal surgery due to cancer of the esophagus, stomach, pancreas, liver, bile ducts, colon or rectum.
2. Patient is willing to participate.
3. Age ≥ 18 years.

Exclusion Criteria:

1. Pregnancy.
2. Previous surgical resection of the digestive tract, excluding appendectomy and/or cholecystectomy.
3. Anticipated operation with preventive ileostomy.
4. The operation is planned to be performed as a matter of urgency.
5. Antibiotic therapy ≤1 month. before surgery.
6. Chronic inflammatory bowel disease (non-specific ulcerative colitis, Crohn's disease) or radiation or other colitis of origin.
7. During the last year, the patient suffered from Cl. difficile colitis or was Cl. difficile carrier, had salmonellosis or others intestinal infections.
8. During the last year, the patient used (\> 3 months) pre-/pro-/(syn)biotics.
9. During the last year, the patient has been taking proton pump inhibitors continuously (\> 6 months).

Primary outcomes:
measure: The similarity in composition between the infection site microbiome and the gut/oral microbiome.
timeFrame: 0 to 30 days
Secondary outcomes:
measure: Incidence of postoperative infections after major abdominal surgery for gastrointestinal cancer.
timeFrame: 0 to 30 days
measure: Incidence of surgical site infections after major abdominal surgery for gastrointestinal cancer.
timeFrame: 0 to 30 days
measure: Major abdominal resection impact on gut microbiome composition.
timeFrame: 0 to 30 days
measure: Gut microbiome-based biomarkers for postoperative infections.
timeFrame: 0 to 30 days
measure: Intestinal wall permeability and local inflammatory markers (LBP, I-FABP, sCD14, etc.) will be evaluated as a potential biomarkers for postoperative infections.
timeFrame: 0 to 30 days
measure: Inflammatory cytokines (IL4; IL2; IP10; IL1β; TNFα; etc.) and pro-inflamatory microRNAs (miRNA-21, miRNA-155, etc.) will be evaluated as a potential biomarkers for postoperative infections.
timeFrame: 0 to 30 days
measure: The proportion of patients developing wound infections among those with positive and negative wound cultures at the conclusion of surgery.
timeFrame: 0 to 30 days
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Vilnius
country: Lithuania
facility: Vilnius University hospital Santaros Klinikos
Study officials:
References: