NCT01551433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 18, 2016

Status Verified

August 1, 2016

Enrollment Period

4.5 years

First QC Date

March 1, 2012

Last Update Submit

August 17, 2016

Conditions

Esophageal Cancer

Keywords

esophagectomyESOPHAGUSWipox instrumentTissue OxygenationAnastomotic Leak11-192

Outcome Measures

Primary Outcomes (1)

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

    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).

    2 years

Secondary Outcomes (3)

  • To correlate various demographic

    2 years

  • To correlate anastomotic site tissue oxygenation with the postdischarge incidence of stricture

    2 years

  • To correlate clinical variables

    2 years

Study Arms (1)

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)

Interventions

wireless pulse oximeter (Wipox)DEVICE

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.

Also known as: 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.
Pts scheduled for Ivor Lewis esophagectomy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Thoracic Surgery clinics

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Esophageal NeoplasmsAnastomotic Leak

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Officials

  • Prasad Adusumilli, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 12, 2012

Study Start

February 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 18, 2016

Record last verified: 2016-08

Locations

US(1)