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

NCT05523154 | Terminated Results FDA Device

• 2 other identifiers: 21-004234NCI-2022-06735
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Pancreatic Neoplasm; Malignant Pancreatic Neoplasm

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Surgical Site Infections

  Assessed by incidence of surgical site infections (SSI), classified using American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) definitions. Diagnostics tests to evaluate for SSI included physical examination, laboratory testing, and imaging such as computed tomography (CT) and ultrasound (US). Patients with complicated hospital courses returned for clinical visit after approximately 2 weeks with cross sectional CT imaging and laboratory testing with further follow up visits as clinically indicated. In the instance of an uneventful hospital course, patients returned at 4 weeks from their date of discharge for a clinical visit with CT imaging and laboratory testing. After this first routine follow-up appointment with surgery, patients continued to follow with medical oncology and with the surgical clinic on an as needed basis.

  Up to 90 days

• Improved Antibiotic Stewardship - Number of Antibiotics

  Assessed by the total number of antibiotics administered.

  Up to 90 days

• Improved Antibiotic Stewardship - Duration

  Assessed by the number of days patients were on antibiotics.

  Up to 90 days

Secondary Outcomes (1)

• Timeliness of Sample Analysis

  Up to 90 days

Study Arms (2)

Arm I (biospecimen collection, routine testing)

ACTIVE COMPARATOR

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

Procedure: Biospecimen Collection; Other: Laboratory Procedure

Arm II (biospecimen, nanopore sequencing, routine testing)

EXPERIMENTAL

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

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

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of bile samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (biospecimen collection, routine testing); Arm II (biospecimen, nanopore sequencing, routine testing)

Laboratory Procedure OTHER

Undergo routine laboratory testing

Also known as: lab exam, Lab Test, Lab Tests, lab_exam, Laboratory Test, laboratory_test, Test, Tests

Arm I (biospecimen collection, routine testing); Arm II (biospecimen, nanopore sequencing, routine testing)

Nanopore Sequencing DEVICE

Undergo nanopore sequencing

Also known as: Oxford Nanopore, Oxford Nanopore Sequencing, Oxford Nanopore Sequencing Technology

Arm II (biospecimen, nanopore sequencing, routine testing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 18 year (yr) male (M) or female (F)
• Undergoing pancreaticoduodenectomy or total pancreatectomy for any benign or malignant indication with informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Specimen Handling; Clinical Laboratory Techniques; Nanopore Sequencing

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Sequence Analysis; Genetic Techniques

Limitations and Caveats

This study was limited in that it was terminated early resulting in a small number of subjects being analyzed

Results Point of Contact

• Title: Dr. Marina Walther-Antonio
• Organization: Mayo Clinic

waltherantonio.marina@mayo.edu

(507) - 284-2282

Study Officials

• Marina R. Walther-Antonio, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

• Mark J. Truty, MD, MS

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 31, 2022
• Study Start: January 19, 2023
• Primary Completion: September 12, 2023
• Study Completion: November 27, 2023
• Last Updated: February 18, 2025
• Results First Posted: February 18, 2025

Record last verified: 2025-01

Locations

US (1)