Randomized Clinical Trial Comparing Three Dimension Laparoscopic and Open Surgery for Perihiliar Cholangiocarcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- TNM Staging
研究概览
简要总结
Cholangiocarcinoma (CCA) is the most common biliary tract malignancy and the second most common primary hepatic malignancy. The prognosis of CCA is dismal. Surgery is the only potentially curative treatment, but the majority of patients present with advanced stage disease, and recurrence after resection is common. It is classified into intrahepatic (iCCA), perihilar (pCCA), and distal (dCCA) subtypes. Among all, pCCA is the most common subtype.
This is a prospective, randomized, controlled multicenter trial with two treatment arms, three dimension laparoscopic approach versus open approach. The trial hypothesis is that three dimension laparoscopic surgery has advantages in postoperative recoveries and be equivalent in operation time, oncological results and long-term follow-up compared with open counterpart. The duration of the entire trial is two years including prearrangement, follow-up and analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven pCCA.
- •Highly presumed perihlar bile duct malignancy with difficulties to obtain histological evidence.
- •Preoperative staging work up performed by upper abdomen enhanced CT scan.
- •The subject understands the nature of this trial and willing to comply.
- •Ability to provide written informed consent.
- •Patients treated with curative intent in accordance to international guidelines
排除标准
- •Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
- •Subjects undergoing any part for hepatectomy.
- •Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >
- •Synchronous malignancy in other organs.
- •Palliative surgery
结局指标
主要结局
TNM Staging
时间窗: 24 months
According to AJCC guideline, each patients TNM staging were recorded.
Mortality
时间窗: 24 months
Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.
Length of Stay
时间窗: 24 months
Length of stay was defined as the postoperative time interval in days.
R0 Resection Rate
时间窗: 24 months
Negative margin rate.
Bile leakage
时间窗: 24 months
The drain bilirubin was monitored after surgery, any elevation for the bilirubin level or the diagnostic puncture proved bile fluid in abdominal cavity.
Complication rate
时间窗: 24 months
Complication Rate Measure Description Any complication mentioned in the protocol should be carefully record and analyzed, including postoperative hemorrhage, postoperative pancreatic fistula, etc.
次要结局
未报告次要终点
研究者
Renyi Qin
Clinical professor
Tongji Hospital