Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Randomized, Double Blind, Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess
Brief 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.


Options:
A: Inclusion Criteria:

* Patients undergone either pancreaticoduodenectomy (reconstruction by pancreaticojejunostomy) or distal pancreatectomy with an amylase value in drains on postoperative day 1 less than 5000 IU/L

Exclusion Criteria:

* Pancreaticoduodenectomy reconstructed with pancreaticogastrostomy
* Clinical suspect of postoperative haemorrhage within 72hours after the operation
* Clinical suspect of biliary fistula
* Fluid collection greater than 3cm at an ultrasound carried out on postoperative day 3
B: Inclusion Criteria:

* The subject has a surgical indication for distal pancreatectomy.
* In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy.
* At least 18 years of age.
* The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group.
* The subject is willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.

Exclusion Criteria:

* The subject does not have a surgical indication for distal pancreatectomy.
* In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy.
* Less than 18 years of age.
* The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group.
* The subject is not willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.
C: Inclusion Criteria:

* Male or female patients aged 18 years or greater.
* Signed informed consent
* Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy.

Exclusion Criteria:

* Pregnancy
* Patients with malabsorption syndrome, short bowel or chologenic diarrhea not controlled 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-screened after 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 significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment.
* Patients who are at risk for QT prolongation. Risk factors include: patients with electrolyte disturbances such as hypokalemia, hypomagnesemia, and hypocalcemia; patients with a family history of long QT syndrome. syncope, and idiopathic sudden death; patients with concomitant diseases that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism, bradycardia, high-grade AV block, significant cardiac arrhythmias, or cardiac failure; patients using concomitant medications known to prolong the QT interval while receiving protocol treatment. These medications include selected antiarrhythmics, antihistamines, macrolide antibiotics, and /or tricyclic antidepressants as follows:

Albuterol Alfuzosin Amantadine Amiodarone Amitriptyline Amphetamine Arsenic Trioxide Astemizole Atazanavir Atomoxetine Azithromycin Chloroquine Clomipramine Dolasetron Metaproterenol Moxifloxacin Phenermine Phenylpropanolamine

* Those drugs not specifically listed above but possibly suspected of causing QT prolongation would not necessarily preclude patient registration, but would be discussed 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 chronic persistent hepatitis.
* Patients with acute cholecystitis
* Patients with the presence of active or suspected acute or chronic uncontrolled infection 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 that affect 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 the conduct of the study or the evaluation of its results in the opinion of the Investigator.
* Patients who have participated in any clinical investigation with an investigational drug (other then pasireotide) within 30 days prior to dosing.
* Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR or s.c. formulations
* Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study.
D: Inclusion Criteria:

* pancreaticoduodenectomy
* distal pancreatectomy

Exclusion Criteria:

* central pancreatectomy
* total pancreatectomy
* enucleation
* laparoscopic procedure
* resection and reconstruction of portal vein

Answer: C