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

Not Applicable

Terminated

Interventions: Procedure: Biospecimen Collection
Other: Laboratory Procedure
Device: Nanopore Sequencing

Brief Summary: This trial evaluates whether testing of bile with nanopore sequencing results in earlier detection of bacteriobilia (bacteria in bile) that may lead to 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. Usage of nanopore sequencing for detection of 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arm I (biospecimen collection, routine testing)	Biospecimen Collection	Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.
Arm I (biospecimen collection, routine testing)	Laboratory Procedure	Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.
Arm II (biospecimen, nanopore sequencing, routine testing)	Biospecimen Collection	Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.
Arm II (biospecimen, nanopore sequencing, routine testing)	Laboratory Procedure	Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.
Arm II (biospecimen, nanopore sequencing, routine testing)	Nanopore Sequencing	Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Surgical Site Infections	Up to 90 days	Assessed by incidence of surgical site infections (SSI), classified using American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) definitions. Diagnostics tests to evaluate for SSI included physical examination, laboratory testing, and imaging such as computed tomography (CT) and ultrasound (US). Patients with complicated hospital courses returned for clinical visit after approximately 2 weeks with cross sectional CT imaging and laboratory testing with further follow up visits as clinically indicated. In the instance of an uneventful hospital course, patients returned at 4 weeks from their date of discharge for a clinical visit with CT imaging and laboratory testing. After this first routine follow-up appointment with surgery, patients continued to follow with medical oncology and with the surgical clinic on an as needed basis.
Improved Antibiotic Stewardship - Number of Antibiotics	Up to 90 days	Assessed by the total number of antibiotics administered.
Improved Antibiotic Stewardship - Duration	Up to 90 days	Assessed by the number of days patients were on antibiotics.