The purpose of this observational trial is to collect and assesses clinical data from patients with pancreatic cancer who receive a modification of the standard surgical procedure used to remove the tumor. This modified surgical procedure may have less risk of serious complications than other treatment options.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01155882.
PRIMARY OBJECTIVES:
I. To collect clinical data from patients who undergo the Whipple at the Splenic Artery (WATSA) procedure.
II. To determine how effective WATSA is at resecting tumors with negative microscopic margins (R0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins.
III. To determine if WATSA can be performed within the usual range of morbidity and mortality (30 day postoperative mortality) for a standard Whipple procedure.
SECONDARY OBJECTIVES:
I. To determine the survival/recurrence rates at 2 years.
II. To determine the effect of occlusion of the splenic vein at the confluence.
OUTLINE:
Data is collected from patients who undergo WATSA.
After surgery, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorSteven Martin Strasberg