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

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ClinicalTrials.gov Identifier: NCT01551433

Recruitment Status : Completed

First Posted : March 12, 2012

Last Update Posted : August 18, 2016

Sponsor:

Information provided by (Responsible Party):

Memorial Sloan Kettering Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment
Esophageal Cancer	Device: wireless pulse oximeter (Wipox)

Study Design


Study Type :	Observational
Actual Enrollment :	166 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	A Prospective Trial to Evaluate Whether Variations in Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy
Study Start Date :	February 2012
Actual Primary Completion Date :	August 2016
Actual Study Completion Date :	August 2016

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Esophageal Cancer

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Pts scheduled for Ivor Lewis esophagectomy 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.	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. Other Names: Post-operatively, all complications will be recorded and graded by the RSA. Anastomotic leaks present either symptomatically or asymptomatically. An asymptomatic leak is only detected on the routine post-operative esophagram on post-operative days 5-7, and is isusally described as a 'contained leak'. A symptomatic leak is usually becomes evident due to clinical symptoms such as a fever, leukocutosis, or enteric contents in the periesophageal drains.

Group/Cohort

Intervention/treatment

Pts scheduled for Ivor Lewis esophagectomy

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.

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.

Other Names:

Post-operatively, all complications will be recorded and graded by the RSA.
Anastomotic leaks present either symptomatically or asymptomatically. An
asymptomatic leak is only detected on the routine post-operative esophagram on
post-operative days 5-7, and is isusally described as a 'contained leak'. A
symptomatic leak is usually becomes evident due to clinical symptoms such as a
fever, leukocutosis, or enteric contents in the periesophageal drains.

Outcome Measures

Primary Outcome Measures :

association between tissue oxygenation (measured using the Wipox) at the anastomotic site and the incidence of anastomotic leak after an Ivor Lewis esophagectomy. [ Time Frame: 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 :

To correlate various demographic [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The Thoracic Surgery clinics

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551433

Locations


United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators


Principal Investigator:	Prasad Adusumilli, MD	Memorial Sloan Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center This link exits the ClinicalTrials.gov site


Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT01551433 History of Changes
Other Study ID Numbers:	11-192
First Posted:	March 12, 2012 Key Record Dates
Last Update Posted:	August 18, 2016
Last Verified:	August 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:


esophagectomy ESOPHAGUS Wipox instrument	Tissue Oxygenation Anastomotic Leak 11-192

Additional relevant MeSH terms:


Esophageal Neoplasms Anastomotic Leak Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms	Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Postoperative Complications Pathologic Processes

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