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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство da Vinci SP® Single-Port Robotic Surgical System
  The da Vinci SP® Surgical System is designed to enable the performance of surgical procedures using a minimally invasive single-port approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.

Первичные конечные точки

• Completion Using the planned da Vinci SP-assisted Single Port Robot. [Срок оценки: 12 months]
• Intraoperative and post-operative adverse events [Срок оценки: 24 months]
• Number of Positive resection Margins [Срок оценки: 24 months]
• Number of Lymph node yield [Срок оценки: 24 Months]

Вторичные конечные точки (12)

• Physical Status Classification [Срок оценки: Pre-Operative Visit]
• Charlson Comorbidity Index Score [Срок оценки: Pre-Operative Visit]
• Operative Time [Срок оценки: Intraoperative]
• Estimated blood loss [Срок оценки: Intraoperatively]
• Intraoperative complications [Срок оценки: Intraoperatively]
• Postoperative complications [Срок оценки: 10 day, 2 months post surgery]
• Post surgery complications [Срок оценки: 2 months post surgery]
• In-hospital mortality [Срок оценки: 10 days post-surgery]
• Date of Discharge [Срок оценки: 10 days post-surgery]
• Survival [Срок оценки: 10 days, 2, months, annually through year 5]
• Disease reoccurrence [Срок оценки: 10 day, 2 month and annually through year 5]
• 30-Day Readmission [Срок оценки: 30 days post surgery]

Критерии участия

Критерии включения

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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• AdventhHealth — Tampa

Публикации

• Rosemurgy A, Wilfong C, Craigg D, Co F, Sucandy I, Ross S. The Evolving Landscape of Esophageal Cancer: A Four-Decade Analysis. Am Surg. 2019 Sep 1;85(9):944-948. PMID 31638504
• Golkar FC, Ross SB, Sperry S, Vice M, Luberice K, Donn N, Morton C, Hernandez JM, Rosemurgy AS. Patients' perceptions of laparoendoscopic single-site surgery: the cosmetic effect. Am J Surg. 2012 Nov;204(5):751-61. doi: 10.1016/j.amjsurg.2011.07.026. PMID 23140831
• Ross S, Rosemurgy A, Albrink M, Choung E, Dapri G, Gallagher S, Hernandez J, Horgan S, Kelley W, Kia M, Marks J, Martinez J, Mintz Y, Oleynikov D, Pryor A, Rattner D, Rivas H, Roberts K, Rubach E, Schwaitzberg S, Swanstrom L, Sweeney J, Wilson E, Zemon H, Zundel N. Consensus statement of the consortium for LESS cholecystectomy. Surg Endosc. 2012 Oct;26(10):2711-6. doi: 10.1007/s00464-012-2478-y. E PMID 22936433
• Ross S, Roddenbery A, Luberice K, Paul H, Farrior T, Vice M, Patel K, Rosemurgy A. Laparoendoscopic single site (LESS) vs. conventional laparoscopic fundoplication for GERD: is there a difference? Surg Endosc. 2013 Feb;27(2):538-47. doi: 10.1007/s00464-012-2476-0. Epub 2012 Jul 18. PMID 22806533
• Sukharamwala P, Teta A, Ross S, Co F, Alvarez-Calderon G, Luberice K, Rosemurgy A. Over 250 Laparoendoscopic Single Site (LESS) Fundoplications: Lessons Learned. Am Surg. 2015 Sep;81(9):870-5. PMID 26350663
• Rosemurgy AS, Downs D, Swaid F, Ross SB. Laparoendoscopic Single-Site (LESS) Nissen Fundoplication: How We Do It. J Gastrointest Surg. 2016 Dec;20(12):2093-2099. doi: 10.1007/s11605-016-3290-0. Epub 2016 Oct 11. No abstract available. PMID 27730403
• Ryan CE, Ross SB, Sukharamwala PB, Sadowitz BD, Wood TW, Rosemurgy AS. Distal pancreatectomy and splenectomy: a robotic or LESS approach. JSLS. 2015 Jan-Mar;19(1):e2014.00246. doi: 10.4293/JSLS.2014.00246. PMID 25848192
• Barbaros U, Sumer A, Demirel T, Karakullukcu N, Batman B, Icscan Y, Saricam G, Serin K, Loh WL, Dinccag A, Mercan S. Single incision laparoscopic pancreas resection for pancreatic metastasis of renal cell carcinoma. JSLS. 2010 Oct-Dec;14(4):566-70. doi: 10.4293/108680810X12924466008448. PMID 21605524

Идентификаторы

NCT: NCT06562179 · 1907766

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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