A Phase II Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
Condition: Pancreatic Leak; Pancreatic Fistula; Pancreaticoduodenal; Fistula; Pancreatectomy; Hyperglycemia
MeSH terms: Pancreatic Fistula; Hyperglycemia; Fistula
Intervention: Lanreotide Prefilled Syringe
Intervention description: All patients enrolled in this study will receive SOMATULINE DEPOT 120 mg immediately prior to planned pancreatic resection. The pharmacist will dispense loaded syringes of the study drug. The single preoperative dose will be given in the pre-surgical center at the University of Washington by a trained health care professional. The study drug will be injected via the deep subcutaneous route in the superior external quadrant of the buttock.
Intervention MeSH terms: Lanreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a single arm investigator-initiated study designed to test the feasibility and
      potential efficacy of preoperative lanreotide to reduce the risk of postoperative abscess or
      pancreatic leak and fistula. All consenting patients undergoing planned elective
      pancreaticoduodenectomy or distal pancreatectomy for malignancy or suspected malignancy will
      be treated with a single deep subcutaneous dose of lanreotide prior to planned resection on
      the day of surgery. Following this intervention, care will be based on standard treatment
      protocols. Sixty-day mortality and morbidity will be collected for all patients.
    

Eligibility criteria:

        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.