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

• ClinicalTrials.gov Identifier: NCT01551433
• Recruitment Status: Completed
• First Posted: March 12, 2012
• Last Update Posted: August 18, 2016
• Sponsor: Memorial Sloan Kettering Cancer Center
• 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

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.

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.
3. 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

• 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

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 

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT01551433
• Other Study ID Numbers: 11-192
• First Posted: March 12, 2012
• 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:

Anastomotic Leak; Postoperative Complications; Pathologic Processes