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A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula.

Primary Objective:

To compare the incidence of postoperative pancreatic fistula (POPF) occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo prior to undergoing distal pancreatectomy for biopsy-proven or suspected neoplasm.

Secondary Objectives:

- To compare the incidence of International Study Group of Pancreatic Surgery (ISGPS)-defined Biochemical Leak occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo in the subset of participants with a drain placed.

- To compare the number of postoperative days in the hospital within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo.

- To compare change from baseline in cancer-specific quality of life at 14 and 60 days after surgery, as measured by the EORTC QLQ-C30, in participants randomized to receive preoperative lanreotide versus placebo.

Protocol Number: 072501
Phase: Phase III
Applicable Disease Sites: Pancreas
Drugs Involved: Lanreotide/Placebo
Principal Investigator: Brett Ecker
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • RWJBarnabas Health
    • Cooperman Barnabas, Livingston
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.