A Pilot Study of Perihepatic Phlebotomy During Hepatic Resections

This is an interventional diagnostic trial for Liver Cancer focused on measuring blood draw, Perihepatic Phlebotomy, 12-236 Read More

Inclusion Criteria:

• All patients with resectable CRLM without extrahepatic metastases confirmed by tissue diagnosis or radiologic exam who are undergoing hepatic resection.
• All patients undergoing hepatic arterial infusion pump placement with or without without hepatic resection.
• Patients may have synchronous or metachronous CRLM
• Patients may have received prior cytotoxic (must be off for at least 2 weeks prior to surgery) or anti-angiogenic therapy (must be off for at least 6 weeks prior to surgery). Specific drugs are listed below.
• 5-FU based chemotherapy - 2 weeks off
• Bevacizumab - 6 weeks off
• Cetuximab or panitumumab - 2 weeks off
• Control patients will include patients consented for pancreaticoduodenectomy for benign or pre-neoplastic lesions. If lesions assumed to be benign turn out to be malignant on final pathology, the blood will be discarded and the patient replaced.
• Patients undergoing a two-stage hepatectomy resection, or who are reevaluated for a second hepatectomy, will be considered for reenrollment to protocol

Exclusion Criteria:

• Evidence of extra-hepatic disease on pre-operative imaging or at operative exploration, excluding the primary colorectal tumor
• Those with known bleeding or clotting diatheses
• Patients diagnosed with chronic inflammatory diseases such as lupus, rheumatoid arthritis, psoriasis, ulcerative colitis, Crohns disease, etc.
• Pre- or intra-operative evidence of portal vein thrombosis or hypertension
• Patients who have taken immune modulating agents in the past 8 weeks including steroids, anti-TNF-α, interferon etc. Patients taking a single dose of Decadron as part of a chemotherapy regimen will not be excluded from the study.
• Patients who take daily anti-inflammatory medications such as COX-2 inhibitors or high dose NSAIDs. Patients taking a daily aspirin or acetaminophen or occasional anti-inflammatory medications will not be excluded from the study.
• If at the discretion of the operating surgeon, blood acquisition would lead to undue morbidity, the patient will be excluded and replaced
• Attending physicians authorized to obtain informed consent may exercise discretion in excluding individuals for appropriate medical or other reasons.