Pancreatic Cancer Clinical Trial
Official title:
Prospective Randomized, Double Blind, Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess
The purpose of this study is to help us learn more about how to lower the patient's risk of
the most common complications after their pancreas operation. After tumors are removed and
the remaining part of the pancreas is connected to the intestine or closed, a leakage of
pancreatic fluid may occur. This fluid may form an "abscess" (collection of pus) or
"fistula" that would need to be drained. A fistula is a persistent leakage of pancreatic
fluid that sometimes occurs after pancreatic surgery. Fistulas, leaks, and abscesses are
complications that are seen in roughly every 15-20 patients out of every 100 that have
pancreas surgeries. Complications like these extend the patient's stay in the hospital after
surgery. These complications may require the patient's doctor to perform additional tests or
procedures to treat them.
The physical and emotional burden these complications place upon patients, as well as the
financial cost to the health care system, can be great. The surgeons at Memorial
Sloan-Kettering Cancer Center are conducting a study to determine if a drug, SOM230, can
help reduce the rate of these complications. SOM230, also known as Pasireotide, is a drug
that has been observed to reduce the rate of similar complications in other studies.
The surgeon would like to compare the effects, good and/or bad, of SOM230 with "placebo"
(solution without medication) to see if SOM230 reduces the rate of fistulas, leaks and
abscesses.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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