Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery

NCT03612687 | Completed FDA Device

• 1 other identifier: 03-14-03E
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. All of these devices and monitors are FDA approved devices and routinely used in the perioperative setting for these cases.

Conditions

Cancer

Keywords

Hemodynamic Monitoring; Perioperative Fluid Management; Hepatobiliary and Pancreas Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of intraoperative complications

  Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding events

  Intraoperative period

Secondary Outcomes (5)

• Extubation time

  up to 48 hours

• Incidence of postoperative blood transfusions

  up to 10 days

• Incidence of postoperative complications

  up to 10 days

• ICU length of stay

  up to 3 days

• Length of hospital stay

  up to 10 days

Study Arms (4)

Laparoscopic Liver Surgery

Laparoscopic Liver Surgical Procedures with minimally invasive hemodynamic monitoring

Device: Minimally invasive hemodynamic monitoring

Laparoscopic Pancreas Surgery

Laparoscopic Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring

Device: Minimally invasive hemodynamic monitoring

Open Liver Surgery

Open Liver Surgical Procedures with minimally invasive hemodynamic monitoring

Device: Minimally invasive hemodynamic monitoring

Open Pancreas Surgery

Open Pancreas Surgical Procedures with minimally invasive hemodynamic monitoring

Device: Minimally invasive hemodynamic monitoring

Interventions

Minimally invasive hemodynamic monitoring DEVICE

Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management

Laparoscopic Liver Surgery; Laparoscopic Pancreas Surgery; Open Liver Surgery; Open Pancreas Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ryan Swan, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: August 2, 2018
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 27, 2022

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)