Use of Pre-planning Models for the Guidance of the Endoscopic Ultrasound-guided Laser Ablation of Pancreatic Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility of pre-planned laser setting in lesion ablation
研究概览
简要总结
Pancreatic ductal adenocarcinoma (PDAC) is the fourth cause of cancer death in Western countries. More than 50% of the patients with PDAC has a local advanced or metastatic disease at the time of the diagnosis. There is a growing interest in the investigation of novel and alternative therapeutic strategies which could be used in synergy with radiotherapy and chemotherapy. These methods include echoendoscopic (EUS) guided locoregional ablation to reduce the tumoral mass.
The most studied technique is the radiofrequency ablation (RFA). Another interesting technique involves the use of the laser source at a wavelength of 1064 nm. Among all the ablative methods, LA is the only one that allows the use of a thinner needle. These features make LA a suitable option for treating focal lesions in high-risk areas or in hard-to-reach locations. A previous study demonstrated the feasibility of this technique in pancreatic solid lesions.
In order to perform a study aimed at the complete treatment of the lesion, it is necessary to identify the laser parameters which are specific to the size and location of the lesion.
The present protocol presents a prospective interventional study aimed at the analysis and applicability of predictive mathematical models for the calculation of laser settings in the ablation of pancreatic lesion by means of a EUS-guided LA.
详细描述
Pancreatic ductal adenocarcinoma (PDAC) is the fourth cause of cancer death in Western countries, with an estimation of 57,600 new cases and 47,050 deaths in 2020 in USA.
Since the number of deaths due to this lethal disease is rapidly increasing, it is estimated to become the second leading cause of tumor-related death by 2030.
The high mortality rate of PDAC is due to several causes, including: i) a poor early diagnosis, ii) the severe biological aggressiveness, and iii) the lack of response to the systemic therapies.
At present, surgical resection, i.e., pancreatectomy, represents the only widely accepted treatment option with the potential to increase long-term survival. However, only 20% of the patients are appropriate surgical candidates at the time of the diagnosis. In the majority of the patients, the disease is at an advanced or metastatic stadium, and the surgical resection does not represent a possible option. In these last cases, only palliative solutions are available.
Nowadays there is a growing interest in the investigation of novel and alternative therapeutic strategies which could be used in synergy with radiotherapy and chemotherapy. These methods include the inoculation o antitumoral agents within the lesion, through laparoscopic, percutaneous or echoendoscopic (EUS) guidance and locoregional ablation to reduce the tumoral mass.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of pancreatic ductal adenocarcinoma (stage III or IV);
- •Inoperable neuroendocrine tumor;
- •Pancreatic metastasis from renal clear cell cancer;
- •Stable situation or progression after chemotherapeutic treatment;
- •Age >18 years;
- •Acquisition of signed Informed Consent;
- •Performance status 0-1-2 (ECOG).
排除标准
- •Absolute contraindications to general anaesthesia or deep sedation;
- •Absence of suitable ultrasound acoustic window for the procedure;
- •Known bleeding disorders that cannot be sufficiently corrected with clotting factors or fresh frozen plasma (FFP);
- •Use of anticoagulants that cannot be discontinued;
- •International normalized ratio (INR) >1.5 or platelet count <50,000;
- •Pregnancy or lactation;
- •Inability to sign informed consent;
- •Other concomitant neoplastic diseases.
结局指标
主要结局
Feasibility of pre-planned laser setting in lesion ablation
时间窗: 1,3,6 months
Evaluate the applicability of mathematical models in predicting the laser settings estimation (energy = power x time) for LA EUS-guided of pancreatic lesions in order to obtain the major volume of ablation with less adverse events. The volume ablation obtained, will be calculated with CT/MRI.
次要结局
- Progression free survival(6 months)
- Rate of resectability(3 months)
研究者
Francesco Maria Di Matteo
Head of Operative Digestive Endoscopy department
Campus Bio-Medico University