Endoscopic Ultrasound-Guided Chemoablation of Pancreatic Cysts - An Efficacy Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of participants with > 50% to < 90% reduction in cyst volume
研究概览
简要总结
This phase II trial tests the effect of endoscopic ultrasound (EUS)-guided chemoablation in treating patients with pancreatic cysts. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage, and the five-year survival rate is currently less than 10%. Pancreatic cysts are a common precancerous lesion that may develop into pancreatic cancer. An EUS is a procedure in which an endoscope is inserted into the body. An endoscope is a thin, tube-like instrument that has a light and a lens for viewing. A probe at the end of the endoscope is used to bounce high-energy sound waves (ultrasound) off internal organs to make a picture (sonogram). EUS-guided chemoablation uses a fine needle inserted into the pancreatic cyst to deliver chemotherapy, such as gemcitabine and paclitaxel, directly into the cyst ("intracystic"). Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. An EUS-guided chemoablation, with gemcitabine and paclitaxel, may be an effective minimally invasive strategy to destroy abnormal or precancerous cells while reducing exposure to the rest of the body in patients with pancreatic cysts.
详细描述
PRIMARY OBJECTIVE:
I. To assess the efficacy of EUS-chemoablation of pancreatic cystic neoplasms (PCNs).
SECONDARY OBJECTIVES:
I. To assess the safety of EUS-guided chemoablation of PCNs. II. To assess the long-term response to EUS-chemoablation.
OUTLINE:
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
盲法说明
Independent radiologists, unaware of treatment details, assess cyst resolution on follow-up imaging.
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
- •A diagnosis of a pancreatic cystic neoplasm (PCN) confirmed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) including cyst fluid next-generation sequencing (NGS) and/or EUS-needle based confocal laser endomicroscopy (nCLE) and/or EUS-through the needle biopsy (TTNB)
- •The pancreatic cystic lesion (PCL) measures at least 1 cm in diameter on CT, MRI/MRCP, or EUS
- •This cohort may include patients with PCNs previously treated with other ablative modalities include EUS-radiofrequency ablation (RFA) (NCT05961982, institutional review board [IRB]: 2023C0004) or EUS-pulsed electric field (PEF) (IRB 20251089) who have shown either no response or only a partial response to therapy
- •The patient is not a surgical candidate. Common clinical scenarios include-
- •Cirrhosis of the liver (common clinical scenario)
- •Advanced (≥ 75 years) age (common clinical scenario)
- •Morbid obesity
- •Significant cardiorespiratory comorbidity
- •Patient's choice (patient elects for non-surgical management)
- •Other significant comorbid conditions that impose prohibitive surgical risks
- •Estimated life expectancy of at least 1 year
- •Capable of giving written informed consent or has a legally authorized representative (LAR) to consent for them
- •Women of childbearing potential must have a negative pregnancy test (serum/urine) on the day of treatment. Pregnancy testing is the routine standard of care practice in the endoscopy laboratory for all patients undergoing endoscopy and sedation for endoscopy
排除标准
- •Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it unsafe for the patient to participate in the study
- •Any psychiatric disorder making reliable informed consent impossible
- •Pregnancy or breast-feeding
- •Pregnant patients will be excluded due to confounding variables
- •Contraindication to general anesthesia after review by Ohio State University (OSU) Preoperative Assessment Clinic (OPAC)
- •Non-English speaking individuals are excluded because study materials, consent forms, and validated patient-reported assessments are available only in English, and interpreter-mediated consent could compromise comprehension of procedural risks associated with an investigational intervention
研究组 & 干预措施
Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)
Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.
干预措施: Ablation Therapy (Procedure)
Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)
Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.
干预措施: Endoscopic Ultrasound-Guided Fine-Needle Aspiration (Procedure)
Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)
Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.
干预措施: Endoscopic Ultrasound (Procedure)
Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)
Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.
干预措施: Magnetic Resonance Cholangiopancreatography (Procedure)
Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)
Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.
干预措施: Gemcitabine Hydrochloride (Drug)
Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)
Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.
干预措施: Paclitaxel (Drug)
Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)
Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.
干预措施: Biospecimen Collection (Procedure)
Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)
Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.
干预措施: Computed Tomography (Procedure)
Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)
Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.
干预措施: Electronic Health Record Review (Other)
Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)
Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.
干预措施: Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Number of participants with > 50% to < 90% reduction in cyst volume
时间窗: At 12 months after EUS-guided chemoablation
Determined using standard of care surveillance imaging, MRI/MRCP, (or CT with pancreas protocol) or endoscopic ultrasound
Number of participants with < 50% reduction in cyst volume
时间窗: At 12 months after EUS-guided chemoablation
Determined using standard of care surveillance imaging, MRI/MRCP, (or CT with pancreas protocol) or endoscopic ultrasound
Number of participants with greater than 90% reduction in cyst volume
时间窗: At 12 months after endoscopic ultrasound (EUS)-guided chemoablation
Number of participants with greater than 90% reduction in cyst volume - Determined using standard of care surveillance imaging, magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP), computed tomography (CT) with pancreas protocol, or endoscopic ultrasound (EUS).
次要结局
- Proportion of adverse events attributable to EUS-chemoablation(Up to 30 days post procedure)
研究者
Somashekar Krishna
Principal Investigator
Ohio State University Comprehensive Cancer Center