A Phase II Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula

Inclusion Criteria

• Male or female patients age ≥ 18 years
• Candidate for planned elective pancreaticoduodenectomy or distal pancreatectomy for malignancy or suspected malignancy
• Able to provide informed consent
• Able to adhere to dose and schedule of visits
• Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to study drug administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female subjects who are at risk of becoming pregnant must agree to use an effective method of contraception such as double barrier contraception, an injectable, combined oral contraceptive or an intra-uterine device (IUD). The subject must agree to use the contraception during the whole period of the study and for eight months after the last study drug administration. Non childbearing potential is defined as being postmenopausal for at least 1 year, or permanently sterilized at least 3 months before study entry.
• Male subjects must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception.

Exclusion Criteria

• Use of disallowed concomitant medications
• Has been treated with a Somatostatin analogs (SSA) at any time prior to planned study drug administration, except if that treatment was for less than 15 days of short acting SSA or one dose of long acting SSA and the treatment was received more than 6 weeks prior to randomization
• Planned tumor enucleation or total pancreatectomy
• Pregnancy or breastfeeding
• Malabsorption syndrome, short bowel, or chologenic diarrhea uncontrolled by specific therapeutic interventions
• New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina, sustained ventricular arrhythmia, advanced heart block, clinically significant bradycardia, or acute myocardial infarction within six months before enrollment
• Severe renal insufficiency as defined by a calculated creatinine clearance <30 mL/min
• Known allergic reactions to components of the study drug
• Has been treated with Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization
• Treatment with systemic immunosuppressive medications, such as cyclosporine, tacrolimus, or prednisone (≥10 mg daily) within 3 months prior to dosing of study drug
• Treatment with another investigational drug within 10 days prior to dosing of study drug
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.