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Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy

NCT01551433 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 166

Last updated 2016-08-18

No results posted yet for this study

Summary

The purpose of this study is to test whether after an Ivor Lewis esophagectomy (the removal of a portion of the stomach and esophagus with re-attachment) there is an association between the intraoperative level of oxygen at the site where the esophagus is re-attached to the stomach (measured using the Wipox), and the incidence of a disruption at the site of the attachment after the surgery.

Conditions

  • Esophageal Cancer

Interventions

DEVICE

wireless pulse oximeter (Wipox)

In addition to the one Wipox measurement at the planned anastomotic site, the RSA will collect the systemic pulse oximeter reading, blood pressure, and heart rate at the time of the Wipox measurement. These measurements will be obtained as both internal controls of the accuracy of the Wipox (matching the Wipox pulse rate with the patient's), as well as additional variables to control for when assessing factors which might contribute to oxygen saturation at the anastomotic site. Pre-operative demographic information will be collected. This will include age, sex, any co-morbidities (cardiac, diabetes, respiratory), and use of pre-operative chemotherapy or chemo-radiotherapy.

Sponsors & Collaborators

Principal Investigators

  • Prasad Adusumilli, MD · Memorial Sloan Kettering Cancer Center

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01551433 on ClinicalTrials.gov