A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AdventHealth
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of Lymph node yield
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cholecystectomy Stage 1 - Inclusion Criteria:
- •Patients between the ages of 18 and 80 years of age
- •Either male or female
- •BMI ≤ 26 kg/m2
- •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
- •Gastrectomy Stage 2- Inclusion Criteria:
- •Patients between the ages of 18 and 80 years of age
- •Either men or women
- •BMI ≤ 26 kg/m2
- •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
- •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
- •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
- •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
- •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)
排除标准
- •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
- 另有 12 项未显示
研究组 & 干预措施
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
干预措施: da Vinci SP® Single-Port Robotic Surgical System (Device)
结局指标
主要结局
Number of Lymph node yield
时间窗: 24 Months
Number of lymph node yield in patients with Malignant disease.
Completion Using the planned da Vinci SP-assisted Single Port Robot.
时间窗: 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
时间窗: 24 months
Number of positive resection margins in patients with Malignant disease.
Intraoperative and post-operative adverse events
时间窗: 24 months
The incidence of all intraoperative and post-operative adverse events that occur through the 24-month follow-up period.
次要结局
- Intraoperative complications(Intraoperatively)
- Estimated blood loss(Intraoperatively)
- Charlson Comorbidity Index Score(Pre-Operative Visit)
- Operative Time(Intraoperative)
- Postoperative complications(10 day, 2 months post surgery)
- Physical Status Classification(Pre-Operative Visit)
- In-hospital mortality(10 days post-surgery)
- Date of Discharge(10 days post-surgery)
- 30-day complications(30 days post surgery)
- 30-Day Readmission(30 days post surgery)
- Disease reoccurrence(10 day, 2 month and annually through year 5)
- Survival(10 days, 2, months, annually through year 5)
- Post surgery complications(2 months post surgery)
研究者
Sharona B. Ross, MD
MD, Foregut and HPB Surgeon
AdventHealth