Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess

Inclusion Criteria:

• Male or female patients aged 18 years or greater.

• Signed informed consent

• Candidate for pancreaticoduodenectomy or distal pancreatectomy with or withoutsplenectomy.

Exclusion Criteria:

• Pregnancy

• Patients with malabsorption syndrome, short bowel or chologenic diarrhea notcontrolled by specific therapeutic means.

• Patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 250mg/dl. Note: At the principle investigator's discretion, non-eligible patients can be re-screenedafter adequate medical therapy has been instituted.

• Patients who have congestive heart failure (NYHA Class III or IV), unstable angina,sustained ventricular tachycardia, ventricular fibrillation, clinically significantbradycardia, advanced heart block or a history of acute myocardial infarction withinthe six months preceding enrollment.

• Patients who are at risk for QT prolongation. Risk factors include: patients withelectrolyte disturbances such as hypokalemia, hypomagnesemia, and hypocalcemia;patients with a family history of long QT syndrome. syncope, and idiopathic suddendeath; patients with concomitant diseases that could prolong QT such as autonomicneuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolledhypothyroidism, bradycardia, high-grade AV block, significant cardiac arrhythmias, orcardiac failure; patients using concomitant medications known to prolong the QTinterval while receiving protocol treatment. These medications include selectedantiarrhythmics, antihistamines, macrolide antibiotics, and /or tricyclicantidepressants as follows: Albuterol Alfuzosin Amantadine Amiodarone Amitriptyline Amphetamine Arsenic TrioxideAstemizole Atazanavir Atomoxetine Azithromycin Chloroquine Clomipramine DolasetronMetaproterenol Moxifloxacin Phenermine Phenylpropanolamine

• Those drugs not specifically listed above but possibly suspected of causing QTprolongation would not necessarily preclude patient registration, but would bediscussed with the attending physician prior to initiation of protocol therapy.

• Patients with QTc >450 msec.

• Patients with liver disease such as cirrhosis, chronic active hepatitis or chronicpersistent hepatitis.

• Patients with acute cholecystitis

• Patients with the presence of active or suspected acute or chronic uncontrolledinfection or with a history of immunocompromise, including a positive HIV test result (ELISA and Western blot).

• Patients with abnormal coagulation (INR>1.5) or patients receiving anticoagulants thataffect PT (prothrombin time) or APTT ( activated thromboplastin time)

• Patients with WBC <3 K/mcL; PLT < 100 K/mcL

• Patients who have any current or prior medical condition that may interfere with theconduct of the study or the evaluation of its results in the opinion of theInvestigator.

• Patients who have participated in any clinical investigation with an investigationaldrug (other then pasireotide) within 30 days prior to dosing.

• Known hypersensitivity to somatostatin analogues or any component of the pasireotideor octreotide LAR or s.c. formulations

• Patients with a history of non-compliance to medical regimens or who are consideredpotentially unreliable or will be unable to complete the entire study.