Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions - a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Patient satisfaction
研究概览
简要总结
The goal of this observational study is to evaluate the long-term clinical effectiveness of EUS-RFA and quality of life in patients with pancreatic or adrenal tumors recieving EUS-RFA.
Primary Objectives:
- Clinical effectiveness: To evaluate the proportion of included patients who show doc-umented improvement in their clinical symptoms and biochemical parameters (blood test results) over time.
- Patient satisfaction: To assess patient satisfaction with the procedure and subsequent disease-related quality of life, measured using validated questionnaires.
Secondary Objectives:
- Safety: To determine the proportion of treated patients who experience complications, as defined by the AGREE classification, within 30 days after the procedure.
- Technical success: To assess the proportion of included patients in whom the EUS-RFA procedure can be successfully completed.
Exploratory Objectives:
• To identify factors associated with adverse events and factors related to clinical success or lack there of.
The study is observational. All participant will receive EUS-RFA as part of their standard clinical care.
Participants will:
- Undergo EUS-RFA, in which a fine needle is guided into the tumor using an endo-scope and ultrasound imaging. Radiofrequency energy is applied through the needle to heat and destroy tumor cells while protecting the surrounding tissue.
- Have follow-up visits including blood tests, imaging scans, and clinical evaluations at regular intervals for up to 5 years after treatment.
- Complete validated questionnaires about satisfaction and quality of life.
The study will include approximately 138 patients recruited between 2025 and 2035 from two Danish hospital departments (Herlev and Gentofte Hospital and Rigshospitalet). Data collection will continue until 2040 to assess long-term outcomes.
This study may help determine whether EUS-RFA can serve as a safe and effective alternative to traditional surgery for selected patients with small hormone-producing or benign tumors in the pancreas or adrenal glands, potentially reducing surgical risks and improving recovery and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 with one or more lesions amendable to undergo EUS-RFA
- •Insulinomas ≤ 25 mm confirmed by a 72-h fasting test, cross-sectional scanning, and a biopsy with low Ki67 index (<10%)
- •Non-functional pNEN lesions between 10-20 mm and growing, confirmed by a biopsy with low Ki67 index (<10%), or larger pNEN lesions in patients who are not candidates for surgical treatment
- •Unilateral APA with benign characteristics on non-contrast enhanced CT located in the left adrenal and confirmed lateralization on AVS
- •Adult habile patients
- •Signed informed consent
排除标准
- •Severe multimorbidity (ASA score ≥ IV or ECOG performance score ≥ 4)
- •Uncorrected coagulopathy (INR >1.8 or thrombocyte count < 50 mia/L)
- •Pregnancy
- •Metastatic malignancy with expected remaining life expectancy < 3 years
- •Stenosis in upper GI tract or altered anatomy (e.g. previous gastrectomy) preventing the passage of an echoendoscope
结局指标
主要结局
Patient satisfaction
时间窗: From enrollment and 5 years forward
Patient satisfaction measured through validated questionarie SF-36. Scores for each domain range from 0 to 100, with a higher score defining a more favorable state
Clinical efficacy
时间窗: From enrollment and 5 years forward
Proportion of included patients with documented biochemical response and symptom improvement, or lesion size decrement/cessation of growth in case of MEN1 patients
次要结局
- Adverse events(From enrollment and 5 years forward)
- Technical success(From enrollment and 5 years forward)