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

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

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.

Study Overview

• Status: Terminated
• Conditions: Benign Pancreatic Neoplasm; Malignant Pancreatic Neoplasm
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Laboratory Procedure; Device: Nanopore Sequencing

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (biospecimen collection, routine testing); Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.	Procedure: Biospecimen Collection; Undergo collection of bile samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Laboratory Procedure; Undergo routine laboratory testing; Other Names: Test; Lab Test; Lab Tests; Laboratory Test; Tests; lab exam; lab_exam; laboratory_test
Experimental: Arm II (biospecimen, nanopore sequencing, routine testing); Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.	Procedure: Biospecimen Collection; Undergo collection of bile samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Laboratory Procedure; Undergo routine laboratory testing; Other Names: Test; Lab Test; Lab Tests; Laboratory Test; Tests; lab exam; lab_exam; laboratory_test; Device: Nanopore Sequencing; Undergo nanopore sequencing; Other Names: Oxford Nanopore Sequencing Technology; Oxford Nanopore; Oxford Nanopore Sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Surgical Site Infections	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.	Up to 90 days
Improved Antibiotic Stewardship - Number of Antibiotics	Assessed by the total number of antibiotics administered.	Up to 90 days
Improved Antibiotic Stewardship - Duration	Assessed by the number of days patients were on antibiotics.	Up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeliness of Sample Analysis	Assessed by the time from sample collection to completion of sample analysis, reported in hours.	Up to 90 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Marina R. Walther-Antonio, PhD, Mayo Clinic in Rochester; Principal Investigator: Mark J. Truty, MD, MS, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): September 12, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: 21-004234; NCI-2022-06735 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes