Examining the link between the microbiome and leaks after esophageal cancer surgery
The Correlation Between Microbiome of Esophageal Cancer Patients and Post Esophagectomy Anastomotic Leaks
This study looks at how the bacteria in the gut of patients with esophageal cancer might be linked to leaks that can happen after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Rambam Health Care Campus Academic / other |
| Locations | 1 site (Haifa) |
| Trial ID | NCT06136845 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between the microbiome of patients with esophageal cancer and the occurrence of anastomotic leaks following esophagectomy. It aims to analyze surgical samples from patients who have undergone surgery for non-metastatic esophageal cancer, focusing on those who experienced leaks and those who did not. By understanding this correlation, the study seeks to improve perioperative management and reduce complications associated with esophageal cancer surgery.
Who should consider this trial
Good fit: Ideal candidates include patients with non-metastatic esophageal cancer who have undergone surgery and provided consent for tissue analysis.
Not a fit: Patients who have had a complete response to treatment and lack tumoral tissue for analysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for esophageal cancer patients.
How similar studies have performed: While the correlation between microbiome and surgical outcomes is an emerging field, this specific approach has not been extensively tested in esophageal cancer, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cancer patients who have a surgery sample at Rambam Pathology Department * Given written informed consent to Rambam BioBank or Midgam for collection, storage, collection of information and use for future research * Patients with non-metastatic esophageal cancer (mid/Siewert 1/Siewert 2) who developed esophageal leak * Patients with non-metastatic esophageal cancer (mid/Siewert 1/Siewert 2) who had no post-op complication. Exclusion Criteria: • Patients who had complete response are excluded due to lack of tumoral tissue in the specimen for analysis
Where this trial is running
Haifa
- Rambam Health Care Campus — Haifa, Israel (Recruiting)
Study contacts
- Principal investigator: Irit Ben Aharon, MD — Rambam Health Care Campus
- Study coordinator: Irit Ben Aharon, MD
- Email: I_Benaharon@rambam.health.gov.il
- Phone: +972-4-777-6700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.