A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease
- Conditions
- Hepatopancreaticobiliary and Foregut Operations
- Interventions
- Device: da Vinci SP® Single-Port Robotic Surgical System
- Registration Number
- NCT06562179
- Lead Sponsor
- AdventHealth
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 35
- 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-
- Subject requiring an emergent operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Subjects with malignant disease
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
Fundoplication Stage 1- Exclusion Criteria:
- Subject requiring an emergent operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
Gastrectomy Stage 2- Exclusion Criteria:
- Subject requiring an emergency operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- AJCC 8th edition T2, T3, T4a, T4b tumor pathology (without neoadjuvant therapy unless contraindicated)
- Clinical or radiological evidence of distant metastatic disease
Distal Pancreatectomy Stage 2- Exclusion Criteria:
- Subject requiring an emergent operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- Tumor involvement with surrounding vasculature (e.g., common hepatic artery, superior mesenteric artery, superior mesenteric vein, portal vein)
- Clinical or radiological evidence of metastatic disease
Pancreaticoduodenectomy Stage 3- Exclusion Criteria:
- Subject requiring an emergent operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- Tumor involvement with surrounding vasculature (e.g., T4a for pancreatic disease: common hepatic artery, superior mesenteric artery, superior mesenteric vein, portal vein)
- Tumor involvement with surrounding vasculature (e.g., T3b for bile duct disease: common hepatic artery, superior mesenteric artery, superior mesenteric vein, portal vein)
- Clinical or radiological evidence of metastatic disease
Esophagectomy Stage 3- Exclusion Criteria:
- Subject requiring an emergency operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- AJCC 8th edition T2 (in some circumstances), T3, and T4a tumor pathology (without neoadjuvant therapy)
- Clinical or radiological evidence of distant metastatic disease
Hepatectomy Stage 4- Exclusion Criteria:
- Subject requiring an emergency operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- Perihilar cholangiocarcinoma (i.e., Klatskin tumor)
- Involvement of major vasculature (ex: portal vein, hepatic artery, or inferior vena cava)
- Clinical or radiological evidence of metastatic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description da Vinci SP® Single-Port Robotic Surgical System da Vinci SP® Single-Port Robotic Surgical System This study will be separated into four stages, depending on the condition the participant is diagnosed with. Each Participant will go through (1) one operation. Stage One will include five (5) subjects who undergo cholecystectomy and five (5) subjects who undergo hiatal hernia repair with fundoplication (Nissen or Toupet) for a total of ten (10) subjects. Stage Two will include five (5) subjects who undergo gastrectomy and five (5) subjects who undergo distal pancreatectomy for a total of ten (10) subjects. Stage Three will include five (5) subjects who undergo pancreaticoduodenectomy and five (5) subjects who undergo esophagectomy for a total of ten (10) subjects. Stage Four will include five (5) subjects who undergo hepatectomy
- Primary Outcome Measures
Name Time Method 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.
Number of Positive resection Margins 24 months Number of positive resection margins in patients with Malignant disease.
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 Lymph node yield 24 Months Number of lymph node yield in patients with Malignant disease.
- Secondary Outcome Measures
Name Time Method 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
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.
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 purposesIn-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
30-day complications 30 days post surgery Assessed as number of complications experienced by patient in the 30-day period post-surgery.
Estimated blood loss Intraoperatively Measured after surgery in milliliters of blood. Estimated based on blood infusion volume during the surgery.
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
Intraoperative complications Intraoperatively Incidence rate - number of intraoperatively complications during surgery.
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).
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
Trial Locations
- Locations (1)
AdventhHealth
🇺🇸Tampa, Florida, United States