2023-01-19
2023-09-12
2023-11-27
8
NCT05523154
Mayo Clinic
Mayo Clinic
INTERVENTIONAL
Ȫnswers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-08-23 | 2024-12-09 | 2025-01-27 |
2022-08-29 | 2025-01-27 | 2025-02-18 |
2022-08-31 | 2025-02-18 | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
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
OTHER: Laboratory Procedure
|
| 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
OTHER: Laboratory Procedure
DEVICE: Nanopore Sequencing
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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