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

NCT05523154 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-02-18

Study results available
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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.

Conditions

  • Benign Pancreatic Neoplasm
  • Malignant Pancreatic Neoplasm

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of bile samples

OTHER

Laboratory Procedure

Undergo routine laboratory testing

DEVICE

Nanopore Sequencing

Undergo nanopore sequencing

Sponsors & Collaborators

Principal Investigators

  • Marina R. Walther-Antonio, PhD · Mayo Clinic in Rochester

  • Mark J. Truty, MD, MS · Mayo Clinic in Rochester

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-19
Primary Completion
2023-09-12
Completion
2023-11-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05523154 on ClinicalTrials.gov