Trial Information

Detection of Peritoneal Micrometastasis in Gastric and Pancreatic Cancer in Peritoneal Wash Samples

Positive peritoneal cytology is a predictor of poor outcome in gastric cancer. These
patients generally have a prognosis similar to patients who are clinically or
radiologically classified as having Stage IV disease. Similar, although fewer, observations
have been made in patients with pancreatic cancer. If identified prior to scheduled
resection, an extensive operation may not be required. The purpose of this pilot trial is to
investigate the ability of a quantitative RT-PCR assay to detect cancer cells in peritoneal
washings of patients undergoing laparoscopy for gastric or pancreatic cancer. This assay may
detect mRNA overly expressed in gastric or pancreatic cancer patients with malignant cells
in the peritoneum which cannot be detected by less sensitive means. Results of this assay
will be compared to cytology results, as detected by standard Papanicolaou staining, during
routine laparoscopic peritoneal washings in the absence of visible M1 disease. We anticipate
enrolling 50 gastric cancer patients and 50 pancreatic cancer patients who will be
undergoing laparoscopy as part of their initial management. We plan to enroll 30 patients
undergoing laparoscopy for a presumed benign condition (e.g., gallstones, prophylactic
bilateral salpingo-oophorectomy [BSO]) as negative controls. We estimate accrual will take
approximately 12 months. Once this assay is established with this pilot study, we plan to
evaluate prospectively the incidence, predictors, and clinical significance of positive
cytology, as detected by standard Papanicolaou stainingand RT-PCR of tumor markers. This
study does not conflict with any existing protocol at Memorial Hospital.