Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection

Study Overview
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Brief Summary
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The investigators hypothesize that abnormalities in thromboelastography (TEG) parameters in patients with liver, pancreas, biliary, esophageal, colorectal, and lung adenocarcinoma can serve as biomarkers for oncologic disease burden, cancer recurrence and overall survival as well as thrombotic and hemorrhagic post-operative complications. The investigators further hypothesize that there is histologic pathology correlates to pre-operative TEG abnormalities, and that it identifies patients with virulent tumor biology.

Detailed Description
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Aim 1: Evaluate the correlation between pre-operative TEG parameters and disease burden in patients with a new diagnosis of hepatopancreaticobiliary, esophageal, colorectal, and lung adenocarcinoma vs controls with no known malignancy. Aim 2: Explore if pre- and post-operative TEG parameters vs routine clinical coagulation parameters (platelet count, prothrombin time [PT], partial thromboplastin time [PTT]) are predictive of pre- and post-operative thrombotic (deep vein thrombosis [DVT], pulmonary embolism [PE], stroke, myocardial infarct [MI]) and hemorrhagic complications. Aim 3: Evaluate if correction of TEG parameters after surgery is predictive of curative resection and if the failure of TEG parameters to correct after surgery or chemoradiothearpy is predictive of cancer recurrence and overall survival. Aim 4: Perform proteomic analyses on the tumor microenvironment of cancer tissue samples to investigate whether tumor histology and protein composition is associated with specific TEG derangements that have been previously correlated to poor outcomes, potentially identifying a specific subtype of pancreatic cancer.

Official Title
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Use of Viscoelastic Assays Beyond Coagulation: Pre- and Post-operative TEG

Conditions
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Liver Cancer, Esophageal Cancer, Colorectal Cancer, Lung Adenocarcinoma, Control, Pancreas Cancer, Biliary Cancer

Intervention / Treatment
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* Diagnostic Test: TEG indices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma will be eligible for enrollment in the study 18 Years and older Exclusion Criteria: Under 18 years old prisoners those unable to provide informed consent pregnant women and those undergoing emergent or urgent operative intervention at the time of diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer<br>new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma | Diagnostic Test: TEG indices<br>* Blood samples<br>* Other names: Control;|
| Control<br>Patients undergoing major surgery | Diagnostic Test: TEG indices<br>* Blood samples<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEG indices of coagulation | R time (minutes   coagulation factors), angle (degrees   fibrinogen function), MA (mm   platelets function), and LY30 (%  fibrinolysis) measured at baseline (initial presentation or time of diagnosis), after neoadjuvant chemotherapy (if applicable), pre-operatively (before the induction of general anesthesia), intra-operatively (after tumor removal), post-operative days 1, 3 and 5, and at routine follow up appointments at 2 weeks, 3 months, 6 months and 1 year after surgery. | One Year | 
| Disease burden as measured by TNM staging | Disease burden as measured by TNM staging | One year | 
| Pre- operative thrombotic and hemorrhagic complications. | Pre-operative thrombotic and hemorrhagic complications. | One Year | 
| Recurrence free and overall survival. | Recurrence free and overall survival. | One Year | 
| Proteomic analysis of intro-operative sample tumor microenvironment | Proteomic analysis of intro-operative sample tumor microenvironment | One Year | 
| Post-operative thrombotic and hemorrhagic complications | Post-operative thrombotic and hemorrhagic complications | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Type | Benign, pre-malignant, malignant | One Year | 
| Number of patients with pre-operative nodal | Benign, pre-malignant, malignant | One Year | 
| Number of patients withneuronal invasion | neuronal invasion | One year | 
| Number of patients with mass resectability | mass resectability | One year | 
| Number of patients withcomplete pathologic resection | complete pathologic resection | one year | 
| Number of patients withsurgical margins | surgical margins | One year | 
| blood transfusion requirements | Number of patients withblood transfusion requirements | One Year | 
| pre-operative distant metastasis | Number of patients withpre-operative distant metastasis | One year |