Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
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.