Benign Pancreatic NeoplasmNCT05523154

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

A study testing Biospecimen Collection, Laboratory Procedure and Nanopore Sequencing in people with Benign Pancreatic Neoplasm and Malignant Pancreatic Neoplasm, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Benign Pancreatic Neoplasm, Malignant Pancreatic Neoplasm
What is being tested?: Biospecimen Collection, Laboratory Procedure and Nanopore Sequencing
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 19 Jan 2023to 27 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

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:

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.

Conditions: Benign Pancreatic Neoplasm, Malignant Pancreatic Neoplasm
Being tested: Biospecimen Collection, Laboratory Procedure, Nanopore Sequencing
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of bile samples
Laboratory ProcedureOther
Also called lab exam, Lab Test, Lab Tests, lab_exam
Undergo routine laboratory testing
Nanopore SequencingDevice
Also called Oxford Nanopore, Oxford Nanopore Sequencing, Oxford Nanopore Sequencing Technology
Undergo nanopore sequencing

Study groups in NCT05523154
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Biospecimen Collection; Other: Laboratory Procedure; Device: Nanopore Sequencing

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 90 days
Improved Antibiotic Stewardship - Number of Antibiotics
Assessed by the total number of antibiotics administered.
Measured: Up to 90 days
Improved Antibiotic Stewardship - Duration
Assessed by the number of days patients were on antibiotics.
Measured: Up to 90 days

Secondary outcomes (1)

Timeliness of Sample Analysis
Assessed by the time from sample collection to completion of sample analysis, reported in hours.
Measured: Up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jan 202327 Nov 2023

First posted31 Aug 2022
Study start19 Jan 2023
Primary completion12 Sep 2023
Study completion27 Nov 2023

Why it stopped: lack of funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Benign Pancreatic NeoplasmStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05523154
Sponsor's protocol ID: 21-004234
Other IDs: NCI-2022-06735
Status last verified: Jan 2025
First submitted: 23 Aug 2022
Last updated: 18 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Benign Pancreatic Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nanopore Sequencing for Detecting Bacteria in Bile and Preventing Surgical Site Infections in Patients Undergoing Surgery for Benign or Malignant Pancreatic Tumors
ClinicalTrials.gov ID: NCT05523154
Acronym / sponsor ID: 21-004234
Conditions: Benign Pancreatic Neoplasm, Malignant Pancreatic Neoplasm
Study type: Interventional
Recruitment status: TerminatedReason stopped: lack of funding
Enrolment: 8 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 19 Jan 2023 (actual)
Primary completion: 12 Sep 2023 (actual)
Study completion: 27 Nov 2023 (actual)
First posted: 31 Aug 2022 (actual)
Results: Posted 18 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

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:

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm I (biospecimen collection, routine testing)	Active comparator	Procedure: Biospecimen Collection, Other: Laboratory ProcedurePatients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.
Arm II (biospecimen, nanopore sequencing, routine testing)	Experimental	Procedure: Biospecimen Collection, Other: Laboratory Procedure, Device: Nanopore SequencingPatients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of bile samples	Procedure or surgery	Arm I (biospecimen collection, routine testing), Arm II (biospecimen, nanopore sequencing, routine testing)
Laboratory ProcedureAlso: lab exam, Lab Test, Lab Tests, lab_examUndergo routine laboratory testing	Other	Arm I (biospecimen collection, routine testing), Arm II (biospecimen, nanopore sequencing, routine testing)
Nanopore SequencingAlso: Oxford Nanopore, Oxford Nanopore Sequencing, Oxford Nanopore Sequencing TechnologyUndergo nanopore sequencing	Device	Arm II (biospecimen, nanopore sequencing, routine testing)

Primary outcome

Number of Participants With Surgical Site Infections
Time frame: Up to 90 days
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.
Improved Antibiotic Stewardship - Number of Antibiotics
Time frame: Up to 90 days
Assessed by the total number of antibiotics administered.
Improved Antibiotic Stewardship - Duration
Time frame: Up to 90 days
Assessed by the number of days patients were on antibiotics.

1 secondary outcome

Timeliness of Sample Analysis
Time frame: Up to 90 days

Results and safety

Results posted to the registry on 18 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Biospecimen Collection, Routine Testing)	3	3
Arm II (Biospecimen, Nanopore Sequencing, Routine Testing)	5	5

Primary outcome: Number of Participants With Surgical Site Infections

Time frame: Up to 90 days. Count of participants. Unit: Participants

Measure	Arm I (Biospecimen Collection, Routine Testing) n = 3	Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) n = 5
Value	1	2

Population analysed: To determine whether the use of rapid Oxford Nanopore sequencing technology reduced rates of surgical site infections we compared the number of patients diagnosed with a surgical site infection in Arm II compared to the number of patients diagnosed with a surgical site infection in Arm I.

Primary outcome: Improved Antibiotic Stewardship - Number of Antibiotics

Time frame: Up to 90 days. Mean (Standard Deviation). Unit: Antibiotics Administered

Measure	Arm I (Biospecimen Collection, Routine Testing) n = 3	Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) n = 5
Value	7.7 (2.31)	5.4 (1.82)

Population analysed: To determine whether use of Oxford Nanopore sequencing improved antibiotic stewardship we compared the total number of antibiotics administered to Arm II patients compared to the total number of antibiotics administered to Arm I patients. We also compared the number of days patients were on antibiotics

Primary outcome: Improved Antibiotic Stewardship - Duration

Time frame: Up to 90 days. Mean (Standard Deviation). Unit: Days

Measure	Arm I (Biospecimen Collection, Routine Testing) n = 3	Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) n = 5
Value	21 (14.93)	25.2 (23.30)

Population analysed: To determine whether use of Oxford Nanopore sequencing improved antibiotic stewardship we compared the total number of days patients were on antibiotics to Arm II patients compared to the total number of days patients were on antibiotics to Arm I patients.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected for 90 days post-surgery. Adverse events were assessed daily while inpatient and then weekly while outpatient. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (Biospecimen Collection, Routine Testing)	3 of 3 (100%)	3 of 3 (100%)	0 of 3
Arm II (Biospecimen, Nanopore Sequencing, Routine Testing)	3 of 5 (60%)	5 of 5 (100%)	0 of 5

Limitations and caveats (from the sponsor): This study was limited in that it was terminated early resulting in a small number of subjects being analyzed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marina R. Walther-Antonio, PhD principal investigator

Mayo Clinic in Rochester

Mark J. Truty, MD, MS principal investigator

Mayo Clinic in Rochester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Surgical Site Infections (time frame: Up to 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05523154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.