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

AdventHealth

Status: Enrolling

Conditions: Hepatopancreaticobiliary and Foregut Operations

Treatments: Device: da Vinci SP® Single-Port Robotic Surgical System

Study type: Interventional

Funder types: Other

Identifiers

NCT06562179

1907766

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

da Vinci SP® Single-Port Robotic Surgical System

Experimental group

Description:

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

Treatment:

Device: da Vinci SP® Single-Port Robotic Surgical System