Trial Outcomes & Findings for "Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures (NCT NCT05523154)

Last Updated: 2025-02-18

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

Up to 90 days

Results posted on

2025-02-18

Participant Flow

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

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	3	5
Overall Study COMPLETED	3	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Biospecimen Collection, Routine Testing) n=3 Participants 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	Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) n=5 Participants 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	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	57.7 years STANDARD_DEVIATION 19.14 • n=5 Participants	55.8 years STANDARD_DEVIATION 15.32 • n=7 Participants	56.5 years STANDARD_DEVIATION 15.48 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm I (Biospecimen Collection, Routine Testing) n=3 Participants 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	Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) n=5 Participants 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
Number of Participants With Surgical Site Infections	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 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

Assessed by the total number of antibiotics administered.

Outcome measures

Outcome measures
Measure	Arm I (Biospecimen Collection, Routine Testing) n=3 Participants 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	Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) n=5 Participants 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
Improved Antibiotic Stewardship - Number of Antibiotics	7.7 Antibiotics Administered Standard Deviation 2.31	5.4 Antibiotics Administered Standard Deviation 1.82

PRIMARY outcome

Timeframe: 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.

Assessed by the number of days patients were on antibiotics.

Outcome measures

Outcome measures
Measure	Arm I (Biospecimen Collection, Routine Testing) n=3 Participants 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	Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) n=5 Participants 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
Improved Antibiotic Stewardship - Duration	21 Days Standard Deviation 14.93	25.2 Days Standard Deviation 23.30

SECONDARY outcome

Timeframe: 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.

Assessed by the time from sample collection to completion of sample analysis, reported in hours.

Outcome measures

Outcome measures
Measure	Arm I (Biospecimen Collection, Routine Testing) n=3 Participants 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	Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) n=5 Participants 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
Timeliness of Sample Analysis	163.5 Hours Standard Deviation 87.56	60.9 Hours Standard Deviation 2.32

Adverse Events

Arm I (Biospecimen Collection, Routine Testing)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm II (Biospecimen, Nanopore Sequencing, Routine Testing)

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Biospecimen Collection, Routine Testing) n=3 participants at risk 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	Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) n=5 participants at risk 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
Injury, poisoning and procedural complications Arterial injury	33.3% 1/3 • Number of events 1 • 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).	0.00% 0/5 • 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).
General disorders Fatigue	33.3% 1/3 • Number of events 1 • 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).	0.00% 0/5 • 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).
Vascular disorders Hematoma	33.3% 1/3 • Number of events 1 • 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).	0.00% 0/5 • 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).
Gastrointestinal disorders Intraabdominal hemorrhage	33.3% 1/3 • Number of events 2 • 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).	0.00% 0/5 • 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).
Infections and infestations Bactereremia	66.7% 2/3 • Number of events 2 • 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).	0.00% 0/5 • 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).
Hepatobiliary disorders Cholangitis	33.3% 1/3 • Number of events 1 • 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).	0.00% 0/5 • 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).
Injury, poisoning and procedural complications Pancreatic anastomotic leak	0.00% 0/3 • 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).	20.0% 1/5 • Number of events 1 • 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).
Infections and infestations Abdominal infection/ bacteremia	0.00% 0/3 • 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).	20.0% 1/5 • Number of events 1 • 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).
Cardiac disorders Myocardial infarction	0.00% 0/3 • 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).	20.0% 1/5 • Number of events 1 • 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).
Gastrointestinal disorders GI Bleed	0.00% 0/3 • 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).	20.0% 1/5 • Number of events 1 • 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).

Other adverse events

Other adverse events
Measure	Arm I (Biospecimen Collection, Routine Testing) n=3 participants at risk 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	Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) n=5 participants at risk 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
Gastrointestinal disorders Diarrhea	100.0% 3/3 • Number of events 3 • 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).	0.00% 0/5 • 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).
Blood and lymphatic system disorders Anemia	66.7% 2/3 • Number of events 2 • 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).	0.00% 0/5 • 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).
General disorders Fatigue	33.3% 1/3 • Number of events 1 • 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).	0.00% 0/5 • 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).
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • Number of events 1 • 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).	60.0% 3/5 • Number of events 3 • 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).
Gastrointestinal disorders Nausea/ vomiting	66.7% 2/3 • Number of events 2 • 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).	40.0% 2/5 • Number of events 2 • 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).
Injury, poisoning and procedural complications Post-operative biliary leak	33.3% 1/3 • Number of events 1 • 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).	0.00% 0/5 • 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).
Injury, poisoning and procedural complications Stomal ulcer	33.3% 1/3 • Number of events 1 • 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).	0.00% 0/5 • 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).
Vascular disorders Thromboembolic event	33.3% 1/3 • Number of events 1 • 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).	0.00% 0/5 • 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).

Additional Information

Dr. Marina Walther-Antonio

Mayo Clinic

Phone: (507) - 284-2282

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place