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Trial Title:
The Correlation Between Microbiome of Esophageal Cancer Patients and Post Esophagectomy Anastomotic Leaks
NCT ID:
NCT06136845
Condition:
Esophageal Tumors
Conditions: Official terms:
Esophageal Neoplasms
Anastomotic Leak
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Summary:
Esophageal cancer continues to be one of the most challenging topics and the subjects of
numerous studies. Surgery is the mainstay for curative treatment and the need to improve
all aspects of perioperative management in order to reduce morbidity and mortality,
continues to be of immense importance.
Cited as the sixth most common cause of cancer-related death worldwide, esophageal cancer
has a distinct geographic distribution known as the esophageal cancer belt: north central
China through the central Asian republics to northern Iran, and from eastern to southern
Africa.
Squamous-cell carcinoma and adenocarcinoma are the two main histological subtypes of
esophageal cancer, in a geographic differentiation as well, with squamous-cell carcinoma
as the most common esophageal cancer subtype worldwide. Though adenocarcinoma is at a
considerable rise in Western populations and has become the predominant subtype North
America, Australia and Europe.
Although an ongoing improvement has been marked in the long-term survival after
esophagectomy, it is still a highly invasive procedure with serious post-operative
complications and entails a high morbidity and mortality rates.
Rates of mortality and morbidity range vastly in the literature with 30-day mortality
reaching 11-22%. Complication rates up to 50%, with anastomotic leaks as the main
complication ranging widely 0-35%.
Various risk factors have been proposed as contributors to mortality and morbidity in
general and to anastomotic leaks in particular. These include both patient and tumoral
characteristics such as premedical history and perioperative factors as tumor location,
surgical technique and perioperative treatment.
The microbiome as a contributor to a patients' disease progression and management is of
great interest in the understanding and better management of cancer patients as a whole
and of the gastrointestinal tract in specific.
The contribution of the microbiome of a patient to colorectal cancer progression and to
anastomotic leaks in the post-operative period has been addressed vastly in the
literature in recent years, showing a distinct correlation to specific microbiota
profile. Shogan et al. depicted a potential molecular mechanism of bacterial-driven
anastomotic leak. It was shown that strains of the commensal organism Enterococcus
faecalis could cause anastomotic leakage by causing direct collagen degradation at the
site of a freshly constructed anastomosis, and indirectly by bacterial-induced over
activation of host matrix metalloproteinase 9 (MMP9).
A geographic differentiation in microbiota of Colorectal Cancer (CRC) was also shown by
comparing tumor tissue and adjacent tissue of Colorectal Cancer patients from the US and
Spain, elaborating yet another aspect of the importance of microbiome of cancer patients.
Oropharyngeal microbiome profiling has been proven as a possible predictor for post
esophagectomy pneumonia projecting on overall survival as well.
A recent study by Rishindra et al from the university of Michigan shows a strong
correlation of post esophagectomy anastomotic leaks and increased bacterial variance in
preoperative oral and gastric flora.
We hypothesize that a correlation exists between microbiome of esophageal cancer patients
and post esophagectomy anastomotic leaks.
According to former evidence microbiota are integrated into the tumor and therefore the
microbial profile of the host (patient) may be represented by tumor microbiota.
In this proposed study, we intend to characterize retrospectively the microbial signature
of esophageal tumors and to study whether there is a correlation between differential
microbial signature and risk of post esophagectomy anastomotic leaks.
Criteria for eligibility:
Study pop:
Patients with esophageal tumors
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Rambam Health Care Campus
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Irit Ben Aharon, MD
Phone:
+972-4-777-6700
Email:
I_Benaharon@rambam.health.gov.il
Start date:
January 13, 2020
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Rambam Health Care Campus
Agency class:
Other
Source:
Rambam Health Care Campus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06136845