Safety and Feasibility of Perihepatic Phlebotomy During Pancreatic and Hepatic Resections
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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: | Safety and Feasibility 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
| Estimated Enrollment: | 36 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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 or resection of a benign head of pancreas mass. 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 |
Inclusion Criteria:
- All patients with resectable CRLM without extrahepatic metastases confirmed by tissue diagnosis or radiologic exam who are undergoing 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 those undergoing pancreatic head resection 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 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| 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 |
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: | December 11, 2012 |
| 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 May 21, 2013