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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01551433
First received: March 1, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 Intervention
Esophageal Cancer
Device: wireless pulse oximeter (Wipox)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    (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.


Estimated Enrollment: 111
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551433

Contacts
Contact: Nabil Rizk, MD 212-639-8357
Contact: Prasad Adusumilli, MD 212-639-8093

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nabil Rizk, MD    212-639-8357      
Contact: Prasad Adusumilli, MD    212-639-8093      
Principal Investigator: Nabil Rizk, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Nabil Rizk, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01551433     History of Changes
Other Study ID Numbers: 11-192
Study First Received: March 1, 2012
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 18, 2014