Role of Circulating Tumor Cells (CTC´s) Spread During Pancreaticoduodenectomy in Metastasis and Survival Rates in Patients With Pancreatic and Periampullary Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Local tumor recurrence
研究概览
简要总结
This multicentre, prospective and randomized study aims(1:1) to compare the rate of recurrence, metastasis and survival according to the levels of intraoperative circulating tumor cells (CTCs) during cephalic duodenopancreatectomy in patients with pancreatic and periampullary tumors.
详细描述
Cephalic duodenopancreatectomy is the technique indicated for patients with pancreatic head carcinoma and periampullar tumors.
There are different technical variants, it is not standardized what is the best option in relation to local recurrence, metastasis and survival.
In the study, patients will be randomized into two study groups with pancreatic and periampullary tumors undergoing cephalic pancreatectomy (NT) vs initial approach by superior mesenteric artery (SMA).
The measurement of circulating tumor cells (CTCs) allows to assess the degree of cellular dissemination due to surgical manipulation.CTCs will be evaluated during surgery (nº CTCs / mL blood). To do this, a maximum of 4 blood samples from the portal vein will be performed, in each study group according to the following scheme:
- NT group: basal (at the beginning of surgery), portal vein pancreatic detachment, postresection (NT2) and before closure (NT3).
- SMA group: basal (at the beginning of surgery), after Kocher maneuver and SMA dissection, postresection, before closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Patients older than 18 years, with adenocarcinomas of the pancreas and potentially resectable periampullary tumors by cephalic duodenopancreatectomy or total duodenopancreatectomy indicated intraoperatively for technical reasons, who voluntarily agree to participate in the study and sign informed consent
排除标准
- •Patients in whom liver metastases or peritoneal carcinomatosis are detected during surgery.
- •Patients with neuroendocrine pancreatic tumors or cystic tumors.
- •Patients in whom tumor resection is not finally achieved because it shows intraoperatively that the tumor is locally advanced and unresectable.
- •Patients with macroscopic residual tumor (R2).
- •High-risk patients with severe pathology (ASA IV) according to the American Association of Anesthesiologists.
- •Patients receiving neoadjuvant therapy
- •Patients in whom the intraoperative pathological anatomy indicates borders of pancreatic resection affected
结局指标
主要结局
Local tumor recurrence
时间窗: From the day of surgery to 3 years of follow-up
Presence (YES or NO) compatible images of local tumor recurrence Valid imaging tests of presence or absence can be checked by: computerized tomography (CT) or magnetic resonance (NMR)
Circulating tumor cells (CTC´s)
时间窗: During the surgery: at the beginning of surgery, immediately after disconnecting the pancreas from the portal vein, just at the moment the pancreatic resection ends and before the skin closed
Change in the concentration of circulating tumor cells (CTCs) levels (nº CTCs/ mL blood) during the surgery, 4 blood samples will be taken from the portal vein
Metastasis
时间窗: From the day of surgery to 3 years of follow-up
Presence (YES or NO) compatible images of metastasis
Patient survival
时间窗: From the day of surgery to 3 years of follow-up
Death (YES OR NO): number of patients dying during study
次要结局
- Morbidity(From the day of surgery up to 6 weeks of follow-up)