Robot-assisted vs Laparoscopic vs Open Radical Cholecystectomy for Gallbladder Cancer: a Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Post operatives complications
研究概览
简要总结
The gallbladder is the most common primary cancer site among the biliary tracts and its incidence is increasing. Its prognosis is still poor with a 5-year survival of almost 20%.
Cholecystectomy is curative in patients with Tis and T1a. For patients with resectable T1b and above disease, radical cholecystectomy is advocated consisting of en bloc resection of the gallbladder, wedge resection of the liver or segment 4b, extrahepatic bile duct, and the regional lymph nodes.
The aim of this study is to compare patients who have undergone Robotic, Laparoscopic and Open liver resection with lymphadenectomy for >T1b gallbladder cancers in a case-matched analysis using propensity scores. The primary endpoints are intra- and postoperative outcomes, and the secondary endpoints long-term oncologic outcomes and feasibility and adequacy of minimally invasive versus traditional open approach.
详细描述
Background:
The gallbladder is the most common primary cancer site among the biliary tracts and its incidence is increasing. Its prognosis is still poor with a 5-year survival of almost 20%.
Cholecystectomy is curative in patients with Tis and T1a. For patients with resectable T1b and above disease, radical cholecystectomy is advocated consisting of en bloc resection of the gallbladder, wedge resection of the liver or segment 4b, extrahepatic bile duct, and the regional lymph nodes.
Traditionally, the open approach was preferred over laparoscopic approach due to the difficulty in achieving adequate lymphadenectomy, the complexity of liver resection, and the risk of gallbladder rupture leading to peritoneal metastases. However, recent meta-analysis, including only few studies, showed that laparoscopy yielded similar long-term oncological outcomes and favorable short-term outcomes in comparison with open surgery. But, laparoscopy to treat this disease is a challenging operation and still entails some limitations, especially regarding the achievement of enough nodes.
In the last years, Robotic surgery is gaining more and more interest in HPB surgery. The robotic approach has advantages such as filtration of hand tremor, seven degrees of freedom of wrist articulation, 3-dimensional (3D) stereoscopic images, and elimination of counterintuitive "fulcrum effect" of conventional laparoscopic surgery. These advantages may facilitate precise dissection for lymphadenectomy and hepatic resection and thus make surgery safe.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>T1b gallbladder cancers
- •Age at least 18 years;
- •Types of surgery include Robotic, Laparoscopic and Open approach
- •A statement by each centre will be required confirming the number of procedures - minimum 1 year of follow up
排除标准
- •not completed data
结局指标
主要结局
Post operatives complications
时间窗: Up to 90 days from surgery
Complications according to Clavien Dindo
Blood Loss
时间窗: intraoperative
Intraoperative estimated blood loss
Pathological outcomes
时间窗: Up to 1 month from surgery
Specimen margins involvement according to the AJCC 8th edition
recurrence
时间窗: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Disease free survival in months
Conversion
时间窗: intraoperative
Conversion to open surgery
operative time
时间窗: Intraoperative
Operative time of the procedure
Survival
时间窗: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival after surgery in months
次要结局
未报告次要终点
研究者
Benedetto Ielpo
MD, PhD, FACS
Hospital del Mar