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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


Phase 3
18 Years
90 Years
Not Enrolling
Both
Pancreatic Cancer, Perioperative/Postoperative Complications

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Trial Information

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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Michael G. Sarr, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068584

NCT ID:

NCT00014651

Start Date:

March 2001

Completion Date:

April 2002

Related Keywords:

  • Pancreatic Cancer
  • Perioperative/Postoperative Complications
  • perioperative/postoperative complications
  • stage I pancreatic cancer
  • Pancreatic Neoplasms
  • Postoperative Complications

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Loyola University Medical CenterMaywood, Illinois  60153
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Medical College of WisconsinMilwaukee, Wisconsin  53226
University of Texas Medical BranchGalveston, Texas  77555-1329
Virginia Mason Medical CenterSeattle, Washington  98111
Brigham and Women's HospitalBoston, Massachusetts  02115
Moffett Cancer Center (South)Tampa, Florida  33601
Taubman Health Care CenterAnn Arbor, Michigan  48109