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A Pilot Study of Perihepatic Phlebotomy During Hepatic Resections

This study is ongoing, but not recruiting participants.
University of Michigan
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center Identifier:
First received: December 11, 2012
Last updated: November 10, 2016
Last verified: November 2016

The purpose of this study is to draw blood from vessels near the liver in patients undergoing liver surgery. This will be performed in both patients with cancer in order to learn more about circulating tumor cells, proteins and DNA mutations in the blood.

The blood in patients with colorectal cancer with liver metastases will be compared to blood taken from patients that do not have cancer that do not have cancer.

Inclusion of patients with benign pathology will allow for the establishment of "normal" values which currently do not exist. We will then study whether tumor mutations can be used to predict recurrence and survival patterns.

Condition Intervention
Liver Cancer
Other: Perihepatic Phlebotomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Perihepatic Phlebotomy During Hepatic Resections

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • ctDNA differences [ Time Frame: once at the time of surgery ]
    to collect preliminary data on perihepatic and peripheral ctDNA differences between prehepatic and posthepatic sites in patients with and without primary colorectal cancers in place.

Secondary Outcome Measures:
  • collect preliminary data [ Time Frame: 1 year ]
    to correlate perihepatic and peripheral ctDNA mutation with recurrence and survival patterns. This will be performed by log-ranks tests of recurrence free survival and overall survival for each gene and possibly for the most common combinations of mutations

Enrollment: 117
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pts having liver or colon surgery
Blood will be obtained from patients at the time of laparotomy for hepatic resection and/or hepatic arterial infusion pump placement, or pancreatic head resection . Blood will be drawn from a peripheral vein or artery (when an arterial catheter is present), the portal vein, and suprahepatic IVC and given to a research assistant and placed on ice followed by immediate processing. Total amount of blood drawn will not exceed fifty milliliters (50ml).
Other: Perihepatic Phlebotomy


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01749332

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
University of Michigan
Principal Investigator: Michael D'Angelica, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT01749332     History of Changes
Other Study ID Numbers: 12-236
Study First Received: December 11, 2012
Last Updated: November 10, 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:
blood draw
Perihepatic Phlebotomy

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on April 21, 2017