Clinical trialPhase 3Completed
Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess
Prospective Randomized, Double Blind, Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess
- Outcome
- Outcome unknown
- Phase
- Phase 3
- Status
- Completed
- Study type
- Interventional
- Start
- October 2009
- Expected end
- September 2014
- Enrollment
- 439 participants
- Sites
- 1
- Primary outcomes
- To Compare 60-day ≥Grade 3 Pancreatic Complication Rates (Fistula, Leak, and Abscess) as Defined by the MSKCC Surgical Secondary Events System Between Patients Who Receive Perioperative SOM230 and Saline Placebo.
- Sponsor
- Other
- Results posted
- 2016-02-01
- Last update
- 1 February 2016
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
To Compare 60-day ≥Grade 3 Pancreatic Complication Rates (Fistula, Leak, and Abscess) as Defined by the MSKCC Surgical Secondary Events System Between Patients Who Receive Perioperative SOM230 and Saline Placebo. [60 days]. Number, percentage of participants. SOM230 (n=150): 9; Placebo (n=149): 21.