High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery

PRIMARY OBJECTIVES:

I. Overall survival (OS) (18 to 27 months after resection).

SECONDARY OBJECTIVES:

I. Disease free survival (DFS). II. Complication rate. III. Site of first-recurrence (by
site, and distant vs. local). IV. Clearance of malignant cells pre vs. post-lavage.

OUTLINE: Patients are randomized to 1 of 3 arms.

Arm I (EIPL-S) extensive intraoperative peritoneal saline lavage: Patients undergo
pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after
removal of tumor, patients receive extensive intraoperative peritoneal saline (EIPL-S) lavage
10 times over 15 minutes.

Arm II (EIPL-D) extensive intraoperative peritoneal distilled water lavage: Patients undergo
pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after
removal of tumor, patients receive extensive intraoperative peritoneal distilled water
(EIPL-D) lavage 10 times over 15 minutes.

Arm III (NO LAVAGE): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or
total pancreatectomy with no extensive lavage after removal of tumor.

After completion of study treatment, patients are followed up every 3 months.

Inclusion Criteria:

- The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy,
distal pancreatectomy, total pancreatectomy)

- A diagnosis of pancreatic or other periampullary cancer is suspected preoperatively

- In the opinion of the surgeon, the subject has no medical contraindications to
pancreatectomy

- The subject is willing to consent to randomization of lavage vs. standard lavage

Exclusion Criteria:

- The subject does not have a surgical indication for pancreatectomy

- In the opinion of the surgeon, the subject has medical contraindications to
pancreatectomy

- The subject is not willing to consent to EIPL-S lavage vs. EIPL-D lavage vs. standard

- Subject with neoadjuvant chemotherapy or chemoradiation

- Known benign or indolent disease, including benign pancreatic cystic tumors or
pancreatic endocrine tumors