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A Prospective Trial to Evaluate Whether Variations in Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy


N/A
21 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

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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 CenterNew York, New York  10021