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The purpose of this study is to determine the impact of antibiotic therapy on the disease progression and overall survival of patients with Pseudomyxoma Peritonei (PMP).
Full description
Single center, open label, historical controlled, phase II study that proposes two courses of standard H. Pylori eradication antibiotic therapy can suppress carcinogenesis and improve the long-term outcomes of patients with PMP. The first course of antibiotics (PrevPac) will be administered before cytoreductive surgery and HIPEC and the second course afterwards. The historical control group will consist of all PMP patients from Mercy Medical Center's Tumor Registry who did not receive perioperative antibiotic treatment. Long-term statistical outcomes will be calculated using the Kaplan-Meier method and Cox proportional hazard ratio to compare pertinent variable. 80 subjects to be enrolled over 2 years, with a 5 year follow-up period.
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Inclusion criteria
Absolute neutrophil count (ANC) ≥1,000/mm3 Platelets ≥100,000/mm3 Hemoglobin ≥ 8.5 g/dL
Renal function:
Creatinine ≤1.5 times the upper limit of normal (ULN) or calculated creatinine clearance ≥60ml/min
Hepatic function:
Bilirubin ≤1.5 times ULN Alanine aminotransferase (ALT) ≤3 times ULN Aspartate aminotransferase (AST) ≤3 times ULN
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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