Clinical trial NCT06562179: A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease
Official title: A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatopancreaticobiliary and Foregut Operations
Keywords: SP DaVinci
Gallbladder removal
Esophageal procedures
Gastric resections
Pancreas procedures
Liver procedures
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Completion Using the planned da Vinci SP-assisted Single Port Robot.
timeFrame: 12 months
measure: Intraoperative and post-operative adverse events
timeFrame: 24 months
measure: Number of Positive resection Margins
timeFrame: 24 months
measure: Number of Lymph node yield
timeFrame: 24 Months
Secondary outcomes:
measure: Physical Status Classification
timeFrame: Pre-Operative Visit
measure: Charlson Comorbidity Index Score
timeFrame: Pre-Operative Visit
measure: Operative Time
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperatively
measure: Intraoperative complications
timeFrame: Intraoperatively
measure: Postoperative complications
timeFrame: 10 day, 2 months post surgery
measure: Post surgery complications
timeFrame: 2 months post surgery
measure: In-hospital mortality
timeFrame: 10 days post-surgery
measure: Date of Discharge
timeFrame: 10 days post-surgery
measure: Survival
timeFrame: 10 days, 2, months, annually through year 5
measure: Disease reoccurrence
timeFrame: 10 day, 2 month and annually through year 5
measure: 30-Day Readmission
timeFrame: 30 days post surgery
measure: 30-day complications
timeFrame: 30 days post surgery
Other outcomes:
Locations:
city: Tampa
country: United States
facility: AdventhHealth
state: Florida
Study officials:
affiliation: AdventHealth
name: Sharona Ross, MD
role: PRINCIPAL_INVESTIGATOR
References:
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