TerminatedNot Applicable

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

Stopped: lack of funding

United States8 participantsStarted 2023-01-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial has been terminated, can you tell me why it was stopped early, and whether that affects anything about my current treatment plan for my pancreatic condition?
2This trial was testing whether rapid microbiome analysis of bile duct cultures could help reduce surgical site infections — is this kind of advanced testing available to me outside of a clinical trial, or is it still mostly experimental?
3The study was looking at improving antibiotic stewardship, meaning using fewer or shorter courses of antibiotics — how are decisions about my antibiotics currently being made, and is there a risk I could receive antibiotics I don't need after a procedure?
4Since this trial involved pancreatic surgery, can you walk me through what the standard approach to preventing and treating infections looks like for my specific situation, given that this research didn't reach completion?
5Are there other active studies or newer approaches to bile duct infection management that might be relevant to me, now that this particular trial is no longer enrolling?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Surgical Site Infections

Timeframe: Up to 90 days

Improved Antibiotic Stewardship - Number of Antibiotics

Timeframe: Up to 90 days

Improved Antibiotic Stewardship - Duration

Timeframe: Up to 90 days

Trial details

NCT IDNCT05523154

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-12

Results submitted2024-12-09

View on ClinicalTrials.gov More Benign Pancreatic Neoplasm trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.