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

Mayo Clinic

Status: Terminated

Conditions: Benign Pancreatic Neoplasm; Malignant Pancreatic Neoplasm

Treatments: Other: Laboratory Procedure; Device: Nanopore Sequencing; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05523154

21-004234 (Other Identifier)

NCI-2022-06735 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

8 participants in 2 patient groups

Arm I (biospecimen collection, routine testing)

Active Comparator group

Description:

Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.

Treatment:

Procedure: Biospecimen Collection

Other: Laboratory Procedure

Arm II (biospecimen, nanopore sequencing, routine testing)

Experimental group

Description:

Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.

Treatment:

Procedure: Biospecimen Collection

Device: Nanopore Sequencing

Other: Laboratory Procedure