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

Malignant Pancreatic Neoplasm Clinical Trial

Official title:

Nanopore Sequencing for Detecting Bacteria in Bile and Preventing Surgical Site Infections in Patients Undergoing Surgery for Benign or Malignant Pancreatic Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05523154
• Other study ID #: 21-004234
• Secondary ID: NCI-2022-06735
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: January 19, 2023
• Est. completion date: September 15, 2024

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This early phase I trial evaluates nanopore sequencing for its ability to detect bacteria in bile and prevent 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. Using nanopore sequencing to detect bacteria in the bile of patients undergoing surgery may allow doctors to prevent surgical site infections or treat them sooner or more effectively.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pancreatic Neoplasm
• Neoplasms
• Pancreatic Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of bile samples

Other:
• Laboratory Procedure
Undergo routine laboratory testing

Device:
• Nanopore Sequencing
Undergo nanopore sequencing

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved antibiotic stewardship	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.	Up to 2 years
Primary	Reduction in surgical site infections	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.	Up to 2 years
Secondary	Cost effectiveness (reduced total hospital costs)	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.	Up to 2 years
Secondary	Timeliness of sample analysis	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.	Up to 2 years

External Links

•   Mayo Clinic Clinical Trials