Transthoracic Esophagectomy Clinical Trial
Official title:
Observational Study of Sublingual Microcirculatory Blood Flow Characteristics in Patients Undergoing Transthoracic Esophagectomy
Microcirculatory alterations occur in critically ill patients and those undergoing major
surgeries. The severity of perioperative microvascular alterations appear to be related to
the severity of organ dysfunction after surgery. Non-cardiac thoracic surgeries comprise a
subgroup of high risk surgical procedures which have the potential to significantly affect
and impair microcirculatory function but this patient population has not been well studied.
Esophagectomy surgery in particular produces a profound systemic inflammatory response which
correlates with a number of adverse outcomes. It is likely, though unproven, that
microcirculatory derangements may underly these phenomena. Though the study of
microcirculatory dysfunction in thoracic surgery is in its infancy, the body of available
evidence at this point supports the following hypotheses; that microcirculatory derangements
and dysfunction 1) occur during major surgeries including transthoracic esophagectomy 2) may
be related to SIRS, 3) may predict adverse outcomes, and 4) may be amenable to modification
via specific therapies.
We propose a prospective observational study to determine the effects of transthoracic
esophagectomy on microcirculatory function. Two hundred patients meeting inclusion criteria
undergoing planned transthoracic esophagectomy via thoracotomy incision will be
prospectively enrolled at The University of Virginia. Patients will be followed for 28 days
or until discharge from the ICU. Evaluation of the sublingual, gastric serosal and mucosal
tissues will be performed using sidestream dark field (SDF) imaging using the CytoCam® by
Braedius Medical BV (Huizen, The Netherlands). Scoring of the microcirculation will include
an index of vascular density (perfused vessel density), an assessment of capillary perfusion
(proportion of perfused vessels and microcirculatory flow index) and a heterogeneity index.
Note: the CytoCam® will only take a series of images as consistent with a microscope of
exposed tissue. Also, the FDA Office of Device Evaluations (ODE) General Surgery Devices
Branch One - Light Based/laser (GSDB1) has deemed this device to be exempt from 510(K)
approval.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5021
Data from patient's medical charts before and after surgery (30 days post) will be used for
elucidation of specific complications. We will use the cardiovascular and respiratory
components of the SOFA score as independent measures of organ dysfunction. Acute kidney
injury will be defined by the AKIN criteria as an increase of at least 50% above baseline
serum creatinine and will be graded from stage 1 to 3.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Age 18 through 75 years 2. Subjects are undergoing transthoracic esophagectomy utilizing thoracotomy or thoracoscopy incisions as part of their clinical care. These surgeries include primarily the Ivor Lewis, and three hole (McKeown) esophagectomy procedures and variants thereof. 3. A patent arterial line 4. A patent IV line 5. Must be able to read and speak English 6. Subjects may have current diagnosis of cancer that requires esophagectomy as part of their clinical care. Exclusion Criteria: 1. Subjects unable/unwilling to give informed consent. 2. Cognitively Impaired 3. Prisoners 4. Pregnant females |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
Atasever B, Boer C, Goedhart P, Biervliet J, Seyffert J, Speekenbrink R, Schwarte L, de Mol B, Ince C. Distinct alterations in sublingual microcirculatory blood flow and hemoglobin oxygenation in on-pump and off-pump coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):784-90. doi: 10.1053/j.jvca.2010.09.002. Epub 2010 Nov 5. — View Citation
Bauer A, Kofler S, Thiel M, Eifert S, Christ F. Monitoring of the sublingual microcirculation in cardiac surgery using orthogonal polarization spectral imaging: preliminary results. Anesthesiology. 2007 Dec;107(6):939-45. — View Citation
Jhanji S, Lee C, Watson D, Hinds C, Pearse RM. Microvascular flow and tissue oxygenation after major abdominal surgery: association with post-operative complications. Intensive Care Med. 2009 Apr;35(4):671-7. doi: 10.1007/s00134-008-1325-z. Epub 2008 Oct 21. — View Citation
Koning NJ, Vonk AB, Meesters MI, Oomens T, Verkaik M, Jansen EK, Baufreton C, Boer C. Microcirculatory perfusion is preserved during off-pump but not on-pump cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):336-41. doi: 10.1053/j.jvca.2013.05.026. Epub 2013 Oct 23. — View Citation
van Genderen M, Gommers D, Klijn E, Lima A, Bakker J, van Bommel J. Postoperative sublingual microcirculatory derangement following esophagectomy is prevented with dobutamine. Clin Hemorheol Microcirc. 2011;48(4):275-83. doi: 10.3233/CH-2011-1421. — View Citation
Wright CD, Kucharczuk JC, O'Brien SM, Grab JD, Allen MS; Society of Thoracic Surgeons General Thoracic Surgery Database. Predictors of major morbidity and mortality after esophagectomy for esophageal cancer: a Society of Thoracic Surgeons General Thoracic Surgery Database risk adjustment model. J Thorac Cardiovasc Surg. 2009 Mar;137(3):587-95; discussion 596. doi: 10.1016/j.jtcvs.2008.11.042. Erratum in: J Thorac Cardiovasc Surg. 2009 Jun;137(6):1581. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microcirculation parameters as observed with Sidestream Dark Field Microscopy an indicator of post operative complications | Is Microcirculation derangement in the mucosal bed an indicator of post-operative complications? Can we use the Sidestream Dark Field Microscopy to detect microcirculation derangements as a precursor to post operative complications? | 3 YEARS | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05167682 -
Patient Empowerment for Major Surgery Preparation @ Home
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