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

NCT ID: NCT05523154

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-19
• Study Completion Date: 2023-11-27

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.

Conditions

Benign Pancreatic Neoplasm; Malignant Pancreatic Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (biospecimen collection, routine testing)

Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.

Group Type: ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of bile samples

Laboratory Procedure

Intervention Type: OTHER

Undergo routine laboratory testing

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.

Group Type: EXPERIMENTAL

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of bile samples

Laboratory Procedure

Intervention Type: OTHER

Undergo routine laboratory testing

Nanopore Sequencing

Intervention Type: DEVICE

Undergo nanopore sequencing

Interventions

Biospecimen Collection

Undergo collection of bile samples

Intervention Type: PROCEDURE

Laboratory Procedure

Undergo routine laboratory testing

Intervention Type: OTHER

Nanopore Sequencing

Undergo nanopore sequencing

Intervention Type: DEVICE

Other Intervention Names

Biological Sample Collection; Biospecimen Collected; Specimen Collection; lab exam; Lab Test; Lab Tests; lab_exam; Laboratory Test; laboratory_test; Test; Tests; Oxford Nanopore; Oxford Nanopore Sequencing; Oxford Nanopore Sequencing Technology

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina R. Walther-Antonio, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Mark J. Truty, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2022-06735

Identifier Type: REGISTRY

Identifier Source: secondary_id

21-004234

Identifier Type: -

Identifier Source: org_study_id