To hear about similar clinical trials, please enter your email below

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

Login to your account

Did you forget your password?