CancerNCT03612687
Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery
An observational study of Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a pilot study with the primary objective to validate the use of advanced minimally invasive hemodynamic monitoring with the PreSep™ Central Venous Oximetry Catheter, the Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management in Hepatobiliary and Pancreas Surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Minimally invasive hemodynamic monitoring
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The procedures will be divided by organ systems, liver and pancreas, and by method of surgery, laparoscopic versus open. Five patients will be chosen for each group for a total of 20 patients enrolled. The following procedures will be included in the study: liver resection (>2 segments), distal pancreatectomy and splenectomy, and pancreaticoduodenectomy, including robotic procedures.
Who may be able to join
- 1. Adult male and female patients admitted to Carolinas Medical Center (CMC) with the need for the following surgical procedures: liver resection, distal pancreatectomy and splenectomy, and pancreaticoduodenectomy.
Who cannot join
- Indication for emergency surgery, including pancreatic debridement in an acute setting; ruptured hepatic adenomas/hepatocellular carcinomas
- Suspected inability to comply with trial procedures or understand consent
- Employee at the investigational center, relative or spouse of the investigators
- Patients incarcerated at the time of surgery
- Females who are pregnant or breastfeeding
- Planned use of Cell Saver during surgical procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28204
About this study
Official title: Use of an Advanced Minimally Invasive Hemodynamic Monitoring for Perioperative Fluid Management in Hepatobiliary and Pancreas Surgery: A Pilot Study
This is a pilot study with the primary objective to validate the use of advanced minimally invasive hemodynamic monitoring with the PreSep™ Central Venous Oximetry Catheter, the Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management in Hepatobiliary and Pancreas Surgery. All of these devices and monitors are FDA approved devices and routinely used in the perioperative setting for these cases.
Read the detailed description
Surgical procedures involving the liver and pancreas are complex and involve paying close attention to hemodynamics to keep the patient stable through the duration of the case. Volume overload in liver and pancreas surgery leads to more intraoperative blood loss and rapid volume shifts make the patient unstable and more difficult to manage. Traditional methods of invasive monitoring to determine cardiac output and stroke volume include the placement of a pulmonary artery catheter and an arterial line. With the addition of the FloTrac™ Sensor to the arterial line and the Vigileo™ monitor; a pulmonary artery catheter would be no longer required. The minimally invasive cardiac output monitor connected to the central venous catheter will generate detailed information of cardiac function and fluid status and thereby help monitor and manage the hemodynamics of the patient intraoperatively. The information obtained from the Vigileo™ will be compared to the regular data normally available in patients undergoing hepatobiliary surgery to determine the advantages of using the system to aid in fluid management of the patient.
- Conditions
- Cancer
- Being tested
- Minimally invasive hemodynamic monitoring
- Keywords
- Hemodynamic Monitoring, Perioperative Fluid Management, Hepatobiliary and Pancreas Surgery
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive hemodynamic monitoringDevice
Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Liver Surgery | Laparoscopic Liver Surgical Procedures with minimally invasive hemodynamic monitoring Receives: Device: Minimally invasive hemodynamic monitoring | |
| Laparoscopic Pancreas Surgery | Laparoscopic Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring Receives: Device: Minimally invasive hemodynamic monitoring | |
| Open Liver Surgery | Open Liver Surgical Procedures with minimally invasive hemodynamic monitoring Receives: Device: Minimally invasive hemodynamic monitoring | |
| Open Pancreas Surgery | Open Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring Receives: Device: Minimally invasive hemodynamic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative complications
Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events
Measured: Intraoperative period
Secondary outcomes (5)
Extubation time
Measurement of time to extubation (hours)
Measured: up to 48 hours
Incidence of postoperative blood transfusions
Volume of blood transfused following surgical procedure (mL)
Measured: up to 10 days
Incidence of postoperative complications
Rate of pre-specified postoperative complications (number of patients affected)
Measured: up to 10 days
ICU length of stay
Intensive Care Unit (ICU) length of stay (days)
Measured: up to 3 days
Length of hospital stay
Time to discharge from hospital (days)
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study startMay 2014
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Swan, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612687
- Sponsor's protocol ID
- 03-14-03E
- Status last verified
- Jul 2018
- First submitted
- 22 May 2014
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Advanced Minimally Invasive Hemodynamic Monitoring for Perioperative Fluid Management in Hepatobiliary and Pancreas Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT03612687
- Acronym / sponsor ID
- 03-14-03E
- Conditions
- Cancer
- Keywords
- Hemodynamic Monitoring, Perioperative Fluid Management, Hepatobiliary and Pancreas Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study with the primary objective to validate the use of advanced minimally invasive hemodynamic monitoring with the PreSep™ Central Venous Oximetry Catheter, the Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management in Hepatobiliary and Pancreas Surgery. All of these devices and monitors are FDA approved devices and routinely used in the perioperative setting for these cases.
Detailed description
Surgical procedures involving the liver and pancreas are complex and involve paying close attention to hemodynamics to keep the patient stable through the duration of the case. Volume overload in liver and pancreas surgery leads to more intraoperative blood loss and rapid volume shifts make the patient unstable and more difficult to manage. Traditional methods of invasive monitoring to determine cardiac output and stroke volume include the placement of a pulmonary artery catheter and an arterial line. With the addition of the FloTrac™ Sensor to the arterial line and the Vigileo™ monitor; a pulmonary artery catheter would be no longer required. The minimally invasive cardiac output monitor connected to the central venous catheter will generate detailed information of cardiac function and fluid status and thereby help monitor and manage the hemodynamics of the patient intraoperatively. The information obtained from the Vigileo™ will be compared to the regular data normally available in patients undergoing hepatobiliary surgery to determine the advantages of using the system to aid in fluid management of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Liver Surgery | – | Device: Minimally invasive hemodynamic monitoringLaparoscopic Liver Surgical Procedures with minimally invasive hemodynamic monitoring |
| Laparoscopic Pancreas Surgery | – | Device: Minimally invasive hemodynamic monitoringLaparoscopic Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring |
| Open Liver Surgery | – | Device: Minimally invasive hemodynamic monitoringOpen Liver Surgical Procedures with minimally invasive hemodynamic monitoring |
| Open Pancreas Surgery | – | Device: Minimally invasive hemodynamic monitoringOpen Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The procedures will be divided by organ systems, liver and pancreas, and by method of surgery, laparoscopic versus open. Five patients will be chosen for each group for a total of 20 patients enrolled. The following procedures will be included in the study: liver resection (>2 segments), distal pancreatectomy and splenectomy, and pancreaticoduodenectomy, including robotic procedures.
Key inclusion criteria (1 listed)
- 1. Adult male and female patients admitted to Carolinas Medical Center (CMC) with the need for the following surgical procedures: liver resection, distal pancreatectomy and splenectomy, and pancreaticoduodenectomy.
Key exclusion criteria (6 listed)
- Indication for emergency surgery, including pancreatic debridement in an acute setting; ruptured hepatic adenomas/hepatocellular carcinomas
- Suspected inability to comply with trial procedures or understand consent
- Employee at the investigational center, relative or spouse of the investigators
- Patients incarcerated at the time of surgery
- Females who are pregnant or breastfeeding
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 |
|---|---|---|
| Minimally invasive hemodynamic monitoringUse of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management | Device | Laparoscopic Liver Surgery, Laparoscopic Pancreas Surgery, Open Liver Surgery, Open Pancreas Surgery |
Primary outcome
Incidence of intraoperative complications
Time frame: Intraoperative period
Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events
5 secondary outcomes
Extubation time
Time frame: up to 48 hours
Incidence of postoperative blood transfusions
Time frame: up to 10 days
Incidence of postoperative complications
Time frame: up to 10 days
ICU length of stay
Time frame: up to 3 days
Length of hospital stay
Time frame: up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Ryan Swan, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 27 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of intraoperative complications (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.