Clinical trial NCT05523154: "Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures
Official title: Nanopore Sequencing for Detecting Bacteria in Bile and Preventing Surgical Site Infections in Patients Undergoing Surgery for Benign or Malignant Pancreatic Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Benign Pancreatic Neoplasm
Malignant Pancreatic Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of Participants With Surgical Site Infections
timeFrame: Up to 90 days
measure: Improved Antibiotic Stewardship - Number of Antibiotics
timeFrame: Up to 90 days
measure: Improved Antibiotic Stewardship - Duration
timeFrame: Up to 90 days
Secondary outcomes:
measure: Timeliness of Sample Analysis
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Marina R. Walther-Antonio, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic in Rochester
name: Mark J. Truty, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: