A Prospective Trial to Evaluate Whether Variations in Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy
21 Years
N/A
Both
Esophageal Cancer
Trial Information
A Prospective Trial to Evaluate Whether Variations in Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy
Inclusion Criteria:
- Patients who are scheduled to undergo an open or a minimally invasive Ivor Lewis
esophagectomy
- > or = to 21 years of age
Exclusion Criteria:
- Patients who are not candidates for an esophagectomy as determined by the treating
surgeon
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
association between tissue oxygenation (measured using the Wipox) at the anastomotic site and the incidence of anastomotic leak after an Ivor Lewis esophagectomy.
Outcome Description:
The primary objective of this observational study is to determine whether in patients undergoing Ivor Lewis esophagectomy, low levels of tissue oxygenation at the anastomotic site are associated with increased risk of anastomotic leak (AL).
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Nabil Rizk, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
11-192
NCT ID:
NCT01551433
Start Date:
February 2012
Completion Date:
February 2014
Related Keywords:
- Esophageal Cancer
- esophagectomy
- ESOPHAGUS
- Wipox instrument
- Tissue Oxygenation
- Anastomotic Leak
- 11-192
- Esophageal Diseases
- Esophageal Neoplasms
- Anastomotic Leak
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
