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

Not Applicable

Active, not recruiting

• Conditions: Malignant Pancreatic Neoplasm; Benign Pancreatic Neoplasm
• Interventions: Procedure: Biospecimen Collection; Other: Laboratory Procedure; Device: Nanopore Sequencing

• Registration Number: NCT05523154
• Lead Sponsor: Mayo Clinic

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Study Start: 2023-01-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-04-16
• Study Completion: 2025-04-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• >= 18 year (yr) male (M) or female (F)
• Undergoing pancreaticoduodenectomy or total pancreatectomy for any benign or malignant indication with informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
Improved antibiotic stewardship	Up to 2 years	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.
Reduction in surgical site infections	Up to 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Cost effectiveness (reduced total hospital costs)	Up to 2 years	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.
Timeliness of sample analysis	Up to 2 years	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States