Focal Cryoballoon Ablation for Dysphagia Palliation in Patients with Advanced Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Primary outcome safety
研究概览
简要总结
Rationale:
Dysphagia is commonly encountered in patients with esophageal carcinoma who are no candidates for treatment with curative intent. It often has a considerable impact on quality of life and can cause malnourishment. Current palliative treatments mainly include esophageal stenting and radiotherapy, but these can be associated with substantial drawbacks such as a high rate of adverse events, fatigue or an untimely/ temporary symptom improvement. Recent studies showed promising results for the use of spray cryotherapy as palliation for dysphagia. Moreover, there are suggestions that cryotherapy has a positive effect on the host's anti-tumor response. However, no data exists on the feasibility, efficacy and safety for cryoballoon therapy in the esophagus. Secondly, cryo-immunologic data in patients with EC is lacking.
Objective:
- To evaluate the feasibility of cryoballoon ablation in patients with esophageal carcinoma and symptoms of dysphagia. Additionally, efficacy and safety will be assessed.
- To evaluate the effect of cryoballoon ablation on host's anti-tumor response. Study design: Pilot study, Multi-center Prospective Uncontrolled Intervention
Study Study population: Adult patients (≥18 years) with dysphagia due to incurable esophageal carcinoma Intervention (if applicable): Focal cryoballoon ablation of visible tumor during an upper endoscopy. Cryoballoon ablation will be performed for two cycles of 12 seconds. In total, patients will undergo 3 treatment sessions (range 1-3) with an interval of 1-3 weeks based onthe severity of symptoms reported by the patient.
Main study parameters/endpoints:
-
- Feasibility of cryoballoon ablation defined as technical success of the procedure
-
Safety based on incidence of procedure-related serious adverse events
-
Efficacy defined as success rates two weeks after the last cryoablation treatment based on patient reported symptom improvement, and objective evaluation of the esophageal lumen that is free from tumor
-
Host's anti-tumor response after cryoballoon ablation based on sequential esophageal tumor biopsies and peripheral blood samples
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
- •Age >18 years at time of consent
- •Histopathologically-confirmed esophageal / gastroesophageal cancer
- •Patients in the palliative setting (with or without (future) systemic chemotherapy)
- •Dysphagia defined as a score of ≥2 (able to swallow only semi-solids)
- •Signed written informed consent
排除标准
- •Alternative etiology for dysphagia
- •Inability to pass the ultraslim endoscope
- •Severe medical comorbidities precluding endoscopy
- •Uncorrected coagulopathy
- •Prior distal esophagectomy
- •Previous esophageal varices
- •Expected survival <6 weeks
- •Prior radiotherapy for esophageal cancer
- •T4b esophageal cancer
- •Incapacitated subjects
- •Pregnant or breastfeeding
结局指标
主要结局
Primary outcome safety
时间窗: 2 weeks
Safety based on incidence of all procedure related serious adverse events up to the end of follow-up. The technique is considered to be safe if ≥80% of the procedures is performed without the occurrence of procedure-related serious adverse events.
primary outcome efficacy
时间窗: 2 weeks
Efficacy * Subjective parameters based on clinical success rate at week 2 after last therapy, using the 5 point Likert dysphagia score (0= no dysphagia, 1= dysphagia to solids, 2= dysphagia to semisolids, 3= dysphagia to liquids, 4= dysphagia to saliva). An improvement of one point is considered as clinical success. * Objective parameters: * Ability of the diagnostic endoscope to pass * Percentage of the diameter of the esophageal lumen that is open/ free from tumor, as assessed by the treating endoscopist and two independent assessors, comparing pre- and post-treatment.
primary outcome feasibility
时间窗: 1 day
Feasibility: defined as technical success rates of a full cryotherapy procedure. This includes the ability to pass the scope and the completion of a full circle of freezing and thawing, with the number of cycles needed per site as deemed necessary by the endoscopist. The technique is considered to be feasible if ≥70% of the procedures is technically successful.
次要结局
- secondary outcome efficacy subjective(12 weeks)
- secondary outcome pain(2 weeks)
- secondary outcome safety(12 weeks)
- secondary outcome other palliation(12 weeks)
- Secondary outcome immunology(12 weeks)
研究者
Laura Boer
Principle Investigator
UMC Utrecht