A Pilot Study of Perihepatic Phlebotomy During Pancreatic and Hepatic Resections

This study is currently recruiting participants.
Verified April 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01749332
First received: December 11, 2012
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to assess the safety and likelihood of drawing blood from blood vessels near the liver in patients undergoing liver surgery or pancreas surgery. This will be performed in both patients with cancer and those suspected not to have cancer.

The other purpose of this study is learn more about the tumor cells and proteins circulating in the blood that is taken. The tumor cells and related proteins in patients with colorectal cancer with liver metastases will be compared to blood taken from patients with benign pancreas lesions.

Inclusion of patients with benign pathology will allow for the establishment of "normal" values which currently do not exist


Condition Intervention
Pancreas Cancer
Liver Cancer
Other: Perihepatic Phlebotomy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Perihepatic Phlebotomy During Pancreatic and Hepatic Resections

Resource links provided by NLM:


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

Primary Outcome Measures:
  • feasibility [ Time Frame: once at the time of surgery ] [ Designated as safety issue: Yes ]
    as defined as successful completion of blood draws from all three sites.

  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Safety will be monitored in terms of the following four stopping rules concerning adverse events CTCAE


Secondary Outcome Measures:
  • collect preliminary data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    on perihepatic and peripheral circulating proinflammatory cytokines and circulating tumors cells for potential further study


Estimated Enrollment: 36
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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, infrahepatic IVC 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749332

Contacts
Contact: Michael D'Angelica, MD 212-639-3226
Contact: T Peter Kingham, MD 212-639-5260

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michael D'Angelica, MD    212-639-3226      
Contact: T Peter Kingham, MD    212-639-5260      
Principal Investigator: Michael D'Angelica, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Michael D'Angelica, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01749332     History of Changes
Other Study ID Numbers: 12-236
Study First Received: December 11, 2012
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
blood draw
Perihepatic Phlebotomy
12-236

Additional relevant MeSH terms:
Liver Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014