Trial Information

Minimal Access Surgery for Pancreas Cancer: A Phase II Trial Study I: Staging of Pancreas Cancer

OBJECTIVES: I. Determine whether a comprehensive laparoscopic examination of the abdomen
with laparoscopic ultrasonography improves staging of pancreatic cancer with respect to (a)
better assessment (compared to CT) of the extent of localized extra pancreatic disease, (b)
vascular invasion, (c) regional lymph node involvement, and (d) metastatic deposits in liver
parenchyma. II. Assess whether one of the newer minimally invasive imaging techniques,
laparoscopic ultrasonography, predicts vascular invasion in pancreatic cancer. III. Develop
an optimal cost effective strategy for assessing resectability in pancreatic cancer.

OUTLINE: Patients who have undergone routine clinical staging (CT scan, angiogram, etc.) and
who have been classified as potentially resectable undergo laparoscopy and laparoscopic
ultrasound (L+LUS). At the end of the L+LUS, based on the new findings patients are
reclassified as either potentially resectable or potentially unresectable. All patient then
undergo definitive staging: those who have metastasis to the liver that can be
pathologically confirmed by biopsy at the time of the laparoscopy are classified as
unresectable and do not undergo laparotomy; all others undergo laparotomy and then are
classified as resectable or unresectable. If 8 or more patients are misclassified at the
time of the L+LUS, then this study is terminated.

PROJECTED ACCRUAL: There will be 50 patients accrued into this study with 25 patients in
each stage. In order to accrue 50 patients, approximately 70 patients will undergo the
initial routine clinical staging (CT scan, angiogram, etc.).