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
OBJECTIVES: I. Compare the efficacy of vapreotide versus placebo in reducing postoperative
pancreatic complications in patients undergoing elective pancreatic resection. II. Compare
the postoperative complications occurring within 45 days after surgery unrelated to the
pancreas, days of hospitalization and survival at 45 days after surgery, number of
rehospitalizations, and number of postoperative blood units or packed red blood cells
administered in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are randomized to one of two treatment arms. Arm I: Patients undergo surgical resection on
day 1 and receive vapreotide subcutaneously twice daily on days 1-7. Arm II: Patients
undergo surgical resection and receive a placebo as in arm I. Patients are followed at days
28 and 45.
PROJECTED ACCRUAL: A total of 580 patients (290 per arm) will be accrued for this study.
Interventional
Primary Purpose: Supportive Care
Michael G. Sarr, MD, FACS
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068584
NCT00014651
March 2001
April 2002
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Moffett Cancer Center (South) | Tampa, Florida 33601 |
Taubman Health Care Center | Ann Arbor, Michigan 48109 |