Spots Global Cancer Trial Database for "Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures

Study Description

Brief Summary: This early phase I trial evaluates nanopore sequencing for its ability to detect bacteria in bile and prevent surgical site infections in patients undergoing surgery for benign or malignant pancreatic tumors. Surgical site infections are a significant source of poor outcomes in patients undergoing surgery for pancreatic tumors. In most patients who develop this kind of infection, the bacteria identified as causing the infection is also frequently found to be in the bile at time of surgery. Using nanopore sequencing to detect bacteria in the bile of patients undergoing surgery may allow doctors to prevent surgical site infections or treat them sooner or more effectively.

Detailed Description: PRIMARY OBJECTIVE: I. To improve antibiotic stewardship (reducing duration of peri-operative prophylactic antibiotic regimen, reducing administration of broad-spectrum antibiotic) by providing surgical team with rapid Oxford Nanopore (ONT) sequencing data in the early post-operative setting. SECONDARY OBJECTIVE: I. To reduce the cost of care through reduction in surgical site infection (SSI) and improved antibiotic stewardship. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing. ARM II: Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing. After completion of study, patients' medical records are reviewed for 30 days.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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