Hepatopancreaticobiliary and Foregut Operations
Conditions
Keywords
SP DaVinci, Gallbladder removal, Esophageal procedures, Gastric resections, Pancreas procedures, Liver procedures
Brief summary
The purpose of this study is to collect data to evaluate safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in hepatopancreatic biliary (HPB) and Foregut operations. HPB and Foregut operations of this study consist of cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy.
Interventions
DEVICEda Vinci SP® Single-Port Robotic Surgical System
The da Vinci SP® Surgical System is designed to enable the performance of surgical procedures using a minimally invasive single-port approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.
Sponsors
AdventHealth
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Cholecystectomy Stage 1 - Inclusion Criteria: * Patients between the ages of 18 and 80 years of age * Either male or female * BMI ≤ 26 kg/m2 * ASA ≤ 3 * Diagnosed with benign disease Fundoplication Stage 1- Inclusion Criteria: * Patients diagnosed with GERD and/or hiatal hernia * Patients between the ages of 18 and 80 years of age * Either men or women * BMI ≤ 26 kg/m2 * ASA ≤ 3 Gastrectomy Stage 2- Inclusion Criteria: * Patients between the ages of 18 and 80 years of age * Either men or women * BMI ≤ 26 kg/m2 * ASA ≤ 3 * Diagnosed with benign or relatively early malignant disease of the stomach * AJCC 8th edition T0 or T1 tumor pathology * AJCC 8th edition T2, T3, tumor pathology (following neoadjuvant therapy if necessary) at the discretion of the investigator * Free of metastatic disease Distal Pancreatectomy Stage 2- Inclusion Criteria: * Patients between the ages of 18 and 80 years of age * Either men or women * BMI ≤ 26 kg/m2 * ASA ≤ 3 * Diagnosed with benign or malignant disease of the pancreas * No vascular involvement * Free of metastatic disease Pancreaticoduodenectomy Stage 3- Inclusion Criteria: * Patients between the ages of 18 and 80 years of age * Either men or women * BMI ≤ 26 kg/m2 * ASA ≤ 3 * Diagnosed with benign or malignant disease of the pancreas * Diagnosed with benign or malignant distal bile duct disease * No vasculature involvement (i.e., no T4 disease, pancreatic or Stage 4a or b disease, or distal bile duct Stage 3b or 4 disease) * Free of metastatic disease Esophagectomy Stage 3- Inclusion Criteria: * Patients between the ages of 18 and 80 years of age * Either men or women * BMI ≤ 26 kg/m2 * ASA ≤ 3 * Diagnosed with benign or malignant disease of the esophagus * AJCC 8th edition T0, T1a, T1b, T2 (without other indications for neoadjuvant therapy) tumor pathology * AJCC 8th edition some T2, T3, or T4a, (following neoadjuvant therapy) at the discretion of the investigator * Free of metastatic disease Hepatectomy Stage 4- Inclusion Criteria: * Patients between the ages of 18 and 80 years of age * Either men or women * BMI ≤ 26 kg/m2 * ASA ≤ 3 * Diagnosed with benign or malignant disease of the liver or bile duct * Free of metastatic disease, not including metastatic disease to the liver (e.g., colorectal liver metastases)
Exclusion criteria
Cholecystectomy Stage 1-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion Using the planned da Vinci SP-assisted Single Port Robot. | 12 months | The number of subjects who completed the planned da Vinci SP-assisted operation without conversion to an alternate approach. Conversion to an alternate approach comprises conversion to open, multiport laparoscopic, multiport robotic or hand-assisted approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned operation using the alternate approach. |
| Intraoperative and post-operative adverse events | 24 months | The incidence of all intraoperative and post-operative adverse events that occur through the 24-month follow-up period. |
| Number of Positive resection Margins | 24 months | Number of positive resection margins in patients with Malignant disease. |
| Number of Lymph node yield | 24 Months | Number of lymph node yield in patients with Malignant disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Status Classification | Pre-Operative Visit | Assessment of the fitness of patient before surgery using the ASA Physical Status Score: Class I - A patient in normal health Class II - A patient with mild systemic disease resulting in no functional limitations Class III - A patient with severe systemic disease that limits activity, but is not incapacitating Class IV - A patient with severe systemic disease that is a constant threat to life Class V - A moribund patient not likely to survive without the operation Class VI - A patient already declared brain dead whose organs are being removed for donor purposes |
| Charlson Comorbidity Index Score | Pre-Operative Visit | Predicts one-year mortality for patients with a range of comorbid conditions, helping the physician determine how aggressively to treat a condition. This index score is assessed by assigning points (1,2,3 or 6) based on the likelihood of dying associated to 17 different conditions (co-morbidities). Scores are summed to provide a total score to predict mortality. Comorbidity classification is categorized as low (score ≤ 3), moderate (score 4 and 5), high (score 6 and 7), and very high comorbidity (score ≥ 8) |
| Operative Time | Intraoperative | Measured in minutes |
| Estimated blood loss | Intraoperatively | Measured after surgery in milliliters of blood. Estimated based on blood infusion volume during the surgery. |
| Intraoperative complications | Intraoperatively | Incidence rate - number of intraoperatively complications during surgery. |
| Postoperative complications | 10 day, 2 months post surgery | Incidence number of complications, assessed through electronic medical records (EMR) at 10 days 60 days post-surgery. |
| Post surgery complications | 2 months post surgery | Rate of complications collected in the electronic medical using the Clavien-Dindo classification system for grading adverse events. Classification of surgical complications: Grade I - Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II - Requiring pharmacological treatment with drugs. Blood transfusions and total parenteral nutrition are also included Grade III - Requiring surgical, endoscopic or radiological intervention Grade IIIa - Intervention not under general anesthesia Grade IIIb - Intervention under general anesthesia Grade IV - Life threatening complication (including Central Nervous System (CNS) complications) requiring IC/ICU management Grade IVa - Single organ dysfunction (including dialysis) Grade IVb - Multiorgan dysfunction Grade V - Death of a patient |
| In-hospital mortality | 10 days post-surgery | Has patient expired during in-hospital stay post-surgery. |
| Date of Discharge | 10 days post-surgery | Measured in number of days |
| Survival | 10 days, 2, months, annually through year 5 | Assessed through follow-up visits. Data collected through patient's chart in the electronic medical record (EMR). |
| Disease reoccurrence | 10 day, 2 month and annually through year 5 | Review of EMR records for new diagnosis assessed at schedule visits. Measured in number of days until reoccurrence diagnosis is noted in the patients' record. |
| 30-Day Readmission | 30 days post surgery | Review of EMR records for any readmission following discharge post surgery |
| 30-day complications | 30 days post surgery | Assessed as number of complications experienced by patient in the 30-day period post-surgery. |
Countries
United States
Contacts
CONTACTDaniel Robledo, MS
PRINCIPAL_INVESTIGATORSharona Ross, MD
AdventHealth
Outcome results
None listed