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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-06735 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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lack of funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of bile samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Timeliness of Sample Analysis | Assessed by the time from sample collection to completion of sample analysis, reported in hours. | Up to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marina R. Walther-Antonio, PhD | Mayo Clinic in Rochester | Principal Investigator |
| Mark J. Truty, MD, MS | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Up to 90 days |
Adverse event data was collected for 90 days post-surgery. Adverse events were assessed daily while inpatient and then weekly while outpatient
All recorded adverse events are reported. These include all adverse events Grade III or higher (requiring surgical, endoscopic, or radiological intervention) and all observed or volunteered adverse effects Grade III or higher (serious or non-serious) and abnormal test findings, regardless of the treatment group if applicable or suspected causal relationship to the investigational device (Oxford Nanopore sequencing) or if applicable to other study treatment or diagnostic product(s).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial injury | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
This study was limited in that it was terminated early resulting in a small number of subjects being analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marina Walther-Antonio | Mayo Clinic | (507) - 284-2282 | waltherantonio.marina@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2023 | Dec 9, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2023 | Dec 9, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D000081414 | Nanopore Sequencing |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D017421 | Sequence Analysis |
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|
| Laboratory Procedure | Other | Undergo routine laboratory testing |
|
|
| Nanopore Sequencing | Device | Undergo nanopore sequencing |
|
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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 |
| OG001 | 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 |
|
|
| Primary | Improved Antibiotic Stewardship - Number of Antibiotics | Assessed by the total number of antibiotics administered. | 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 | Posted | Mean | Standard Deviation | Antibiotics Administered | Up to 90 days |
|
|
|
| Primary | Improved Antibiotic Stewardship - Duration | Assessed by the number of days patients were on antibiotics. | 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. | Posted | Mean | Standard Deviation | Days | Up to 90 days |
|
|
|
| Secondary | Timeliness of Sample Analysis | Assessed by the time from sample collection to completion of sample analysis, reported in hours. | 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. | Posted | Mean | Standard Deviation | Hours | Up to 90 days |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| 3 |
| 3 |
| EG001 | 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 | 0 | 5 | 3 | 5 | 5 | 5 |
| Fatigue | General disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
| Intraabdominal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Bactereremia | Infections and infestations | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | Systematic Assessment |
|
| Pancreatic anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Abdominal infection/ bacteremia | Infections and infestations | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| GI Bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Nausea/ vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Post-operative biliary leak | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Stomal ulcer | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005821 | Genetic Techniques |