A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease

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- Exclusion Criteria:

• 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