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Trial Title:
"Answers in Hours" a Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures
NCT ID:
NCT05523154
Condition:
Benign Pancreatic Neoplasm
Malignant Pancreatic Neoplasm
Conditions: Official terms:
Neoplasms
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of bile samples
Arm group label:
Arm I (biospecimen collection, routine testing)
Arm group label:
Arm II (biospecimen, nanopore sequencing, routine testing)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Laboratory Procedure
Description:
Undergo routine laboratory testing
Arm group label:
Arm I (biospecimen collection, routine testing)
Arm group label:
Arm II (biospecimen, nanopore sequencing, routine testing)
Other name:
lab exam
Other name:
Lab Test
Other name:
Lab Tests
Other name:
lab_exam
Other name:
Laboratory Test
Other name:
laboratory_test
Other name:
Test
Other name:
Tests
Intervention type:
Device
Intervention name:
Nanopore Sequencing
Description:
Undergo nanopore sequencing
Arm group label:
Arm II (biospecimen, nanopore sequencing, routine testing)
Other name:
Oxford Nanopore
Other name:
Oxford Nanopore Sequencing
Other name:
Oxford Nanopore Sequencing Technology
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Start date:
January 19, 2023
Completion date:
April 16, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05523154
https://www.mayo.edu/research/clinical-trials