Vapreotide in Pancreas Surgery: A Double-Blind, Placebo-Controlled, Randomized Study of Vapreotide to Prevent Post-Surgical Complications in Patients Undergoing Elective Pancreatic Resection Grant Application Title: Vapreotide to Prevent Complications of Pancreatic Resection

Inclusion Criteria

DISEASE CHARACTERISTICS: Planned elective pancreatic resection due to presumed pancreatic
tumor (either proximal or distal pancreatic lesion) or presumed neoplasm of the ampullary
or periampullary region Require peri-anastomotic drain(s) near the pancreaticoenterostomy
or near the pancreatic stump closure The following are excluded: Emergency surgery of the
pancreas (acute pancreatitis, pancreatic trauma) Known chronic pancreatitis (pancreatic
cancer with duct obstructive chronic pancreatitis allowed) Need for total pancreatectomy
Need for pancreatic transplantation Need for elective pancreatic-cyst anastomosis Need for
pancreatic duct drainage operation without resection (pancreatic stents allowed if
performed with partial pancreatic resection) Enucleation of a pancreatic neoplasm

PATIENT CHARACTERISTICS: Age: 18 to 90 Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL
Renal: Creatinine no greater than 2 times upper limit of normal Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No neoadjuvant or
postoperative adjuvant chemotherapy from 2 weeks before to 2 weeks after surgery Endocrine
therapy: At least 4 weeks since prior somatostatin or somatostatin analogue No other
concurrent somatostatin or somatostatin analogues Radiotherapy: No neoadjuvant or
postoperative adjuvant radiotherapy from 2 weeks before to 2 weeks after surgery Surgery:
See Disease Characteristics Other: No concurrent pancreatic enzyme inhibitors (e.g.,
antiproteases) No concurrent immunosuppressive agents