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

Completed

• Conditions: Esophageal Cancer
• Interventions: Device: wireless pulse oximeter (Wipox)

• Registration Number: NCT01551433
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-12
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• Patients who are scheduled to undergo an open or a minimally invasive Ivor Lewis esophagectomy
• > or = to 21 years of age

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Exclusion Criteria

• Patients who are not candidates for an esophagectomy as determined by the treating surgeon

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pts scheduled for Ivor Lewis esophagectomy	wireless pulse oximeter (Wipox)	During the operation, once the gastric conduit has been mobilized and positioned, and once the anastomotic site has been identified by the surgeon, the assigned RSA will provide the Wipox instrument to the fellow (the primary surgeon will be blinded to the result) who will then obtain one measurement from the anastomotic site.

Primary Outcome Measures

Name	Time	Method
association between tissue oxygenation (measured using the Wipox) at the anastomotic site and the incidence of anastomotic leak after an Ivor Lewis esophagectomy.	2 years	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).

Secondary Outcome Measures

Name	Time	Method
To correlate various demographic	2 years	(age, co-morbidities, smoking history) and clinical variables (pre-operative therapy, intra-operative blood pressure and systemic oxygen saturation) with tissue oxygenation at the anastomotic site. Spearman rank correlation (for continuous variables) and Wilcoxon rank sum test (for categorical variables) will be used to test these associations.
To correlate anastomotic site tissue oxygenation with the postdischarge incidence of stricture	2 years	the association between anastomotic site tissue oxygenation and the incidence of post-discharge stricture observed during the 6 months following surgery will be assessed using Wilcoxon rank sum test (with O2 levels on a continuous scale) and Fisher exact test.
To correlate clinical variables	2 years	(age, co-morbidities, smoking history) and clinical variables (pre-operative therapy, intra-operative blood pressure and systemic oxygen saturation) with tissue oxygenation at the anastomotic site. Spearman rank correlation (for continuous variables) and Wilcoxon rank sum test (for categorical variables) will be used to test these associations.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States