Benign Pancreatic Neoplasm, Malignant Pancreatic Neoplasm
Conditions
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of bile samples
OTHERLaboratory Procedure
Undergo routine laboratory testing
DEVICENanopore Sequencing
Undergo nanopore sequencing
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Site Infections | 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 | Up to 90 days | Assessed by the total number of antibiotics administered. |
| Improved Antibiotic Stewardship - Duration | Up to 90 days | Assessed by the number of days patients were on antibiotics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timeliness of Sample Analysis | Up to 90 days | Assessed by the time from sample collection to completion of sample analysis, reported in hours. |
Countries
United States
Participant flow
Pre-assignment details
This study evaluated the clinical use of Oxford Nanopore Sequencing in characterizing biliary microbial contamination in patients undergoing pancreatic head resection (total pancreatectomy, pancreaticoduodenectomy) surgery. Following enrollment, stratified randomization was performed using surgery type as a stratification factor. Patients that did not complete surgery were, therefore, removed from the study prior to assignment to a study group. assignment to a study group was dependent
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Biospecimen Collection, Routine Testing) Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.
Biospecimen Collection: Undergo collection of bile samples
Laboratory Procedure: Undergo routine laboratory testing | 3 |
| Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.
Biospecimen Collection: Undergo collection of bile samples
Laboratory Procedure: Undergo routine laboratory testing
Nanopore Sequencing: Undergo nanopore sequencing | 5 |
| Total | 8 |
Baseline characteristics
| Characteristic | Arm I (Biospecimen Collection, Routine Testing) | Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Continuous | 57.7 years STANDARD_DEVIATION 19.14 | 55.8 years STANDARD_DEVIATION 15.32 | 56.5 years STANDARD_DEVIATION 15.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 5 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 5 Participants | 8 Participants |
| Region of Enrollment United States | 3 participants | 5 participants | 8 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 5 |
| other Total, other adverse events | 3 / 3 | 5 / 5 |
| serious Total, serious adverse events | 3 / 3 | 3 / 5 |
Outcome results
Primary
Improved Antibiotic Stewardship - Duration
Assessed by the number of days patients were on antibiotics.
Time frame: Up to 90 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Biospecimen Collection, Routine Testing) | Improved Antibiotic Stewardship - Duration | 21 Days | Standard Deviation 14.93 |
| Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) | Improved Antibiotic Stewardship - Duration | 25.2 Days | Standard Deviation 23.3 |
Primary
Improved Antibiotic Stewardship - Number of Antibiotics
Assessed by the total number of antibiotics administered.
Time frame: Up to 90 days
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Biospecimen Collection, Routine Testing) | Improved Antibiotic Stewardship - Number of Antibiotics | 7.7 Antibiotics Administered | Standard Deviation 2.31 |
| Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) | Improved Antibiotic Stewardship - Number of Antibiotics | 5.4 Antibiotics Administered | Standard Deviation 1.82 |
Primary
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.
Time frame: Up to 90 days
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Biospecimen Collection, Routine Testing) | Number of Participants With Surgical Site Infections | 1 Participants |
| Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) | Number of Participants With Surgical Site Infections | 2 Participants |
Secondary
Timeliness of Sample Analysis
Assessed by the time from sample collection to completion of sample analysis, reported in hours.
Time frame: Up to 90 days
Population: To determine whether use of Oxford Nanopore Sequencing resulted in more rapid microbial results we compared the time taken to complete microbial standard cultures in Arm with the time taken to complete Oxford Nanopore sequencing analysis in Arm II.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Biospecimen Collection, Routine Testing) | Timeliness of Sample Analysis | 163.5 Hours | Standard Deviation 87.56 |
| Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) | Timeliness of Sample Analysis | 60.9 Hours | Standard Deviation 2.32 |