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A Pilot Study of Perihepatic Phlebotomy During Pancreatic and Hepatic Resections

Open (Enrolling)
Pancreas Cancer, Liver Cancer

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Trial Information

A Pilot Study of Perihepatic Phlebotomy During Pancreatic and Hepatic Resections

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.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:


Outcome Description:

as defined as successful completion of blood draws from all three sites.

Outcome Time Frame:

once at the time of surgery

Safety Issue:


Principal Investigator

Michael D'Angelica, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2012

Completion Date:

December 2014

Related Keywords:

  • Pancreas Cancer
  • Liver Cancer
  • blood draw
  • Perihepatic Phlebotomy
  • 12-236
  • Liver Neoplasms
  • Pancreatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021