A Pilot Study of Perihepatic Phlebotomy During Pancreatic and Hepatic Resections
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
|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|
- 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
- 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
|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)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749332
|Contact: Michael D'Angelica, MD||212-639-3226|
|Contact: T Peter Kingham, MD||212-639-5260|
|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|
|Principal Investigator:||Michael D'Angelica, MD||Memorial Sloan-Kettering Cancer Center|