Answers in Hours A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nanopore Sequencing for Detecting Bacteria in Bile and Preventing Surgical Site Infections in Patients Undergoing Surgery for Benign or Malignant Pancreatic Tumors

Conditions
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Benign Pancreatic Neoplasm, Malignant Pancreatic Neoplasm

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Laboratory Procedure
* Device: Nanopore Sequencing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 18 year (yr) male (M) or female (F) Undergoing pancreaticoduodenectomy or total pancreatectomy for any benign or malignant indication with informed consent Exclusion Criteria: Women who are pregnant Patients who are institutionalized or incarcerated Patients without the cognitive capacity to consent Patients undergoing emergency pancreaticoduodenectomy or total pancreatectomy Patients enrolled in similar clinical trials involving use of perioperative antibiotics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (biospecimen collection, routine testing)<br>Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing. | Procedure: Biospecimen Collection<br>* Undergo collection of bile samples<br>* Other names: Specimen Collection;Other: Laboratory Procedure<br>* Undergo routine laboratory testing<br>* Other names: Tests;|
| Experimental: Arm II (biospecimen, nanopore sequencing, routine testing)<br>Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing. | Procedure: Biospecimen Collection<br>* Undergo collection of bile samples<br>* Other names: Specimen Collection;Other: Laboratory Procedure<br>* Undergo routine laboratory testing<br>* Other names: Tests;Device: Nanopore Sequencing<br>* Undergo nanopore sequencing<br>* Other names: Oxford Nanopore Sequencing Technology;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved antibiotic stewardship | For continuous variables, t-test will be performed and for binary variables chi-square or fisher's exact testing will be performed as appropriate. Additional analysis will be performed as necessary to determine differences in study arms. | Up to 2 years | 
| Reduction in surgical site infections | For continuous variables, t-test will be performed and for binary variables chi-square or fisher's exact testing will be performed as appropriate. Additional analysis will be performed as necessary to determine differences in study arms. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effectiveness (reduced total hospital costs) | For continuous variables, t-test will be performed and for binary variables chi-square or fisher's exact testing will be performed as appropriate. Additional analysis will be performed as necessary to determine differences in study arms. | Up to 2 years | 
| Timeliness of sample analysis | For continuous variables, t-test will be performed and for binary variables chi-square or fisher's exact testing will be performed as appropriate. Additional analysis will be performed as necessary to determine differences in study arms. | Up to 2 years |