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

Recruiting

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

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Control	TEG indices	Patients undergoing major surgery
Cancer	TEG indices	new diagnosis by the providing physician of hepatopancreaticobiliary, esophageal, colorectal or lung adenocarcinoma

Primary Outcome Measures

Name	Time	Method
Disease burden as measured by TNM staging	One year	Disease burden as measured by TNM staging
TEG indices of coagulation	One Year	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.
Pre- operative thrombotic and hemorrhagic complications.	One Year	Pre-operative thrombotic and hemorrhagic complications.
Recurrence free and overall survival.	One Year	Recurrence free and overall survival.
Proteomic analysis of intro-operative sample tumor microenvironment	One Year	Proteomic analysis of intro-operative sample tumor microenvironment
Post-operative thrombotic and hemorrhagic complications	One Year	Post-operative thrombotic and hemorrhagic complications

Secondary Outcome Measures

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

Locations (1): University of Colorado Denver
🇺🇸
Aurora, Colorado, United States