Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complete stone clearance
研究概览
简要总结
The goal of this clinical trial is to learn if a low-power holmium laser works to treat large and/or difficult bile duct or pancreatic duct stones in adults. It will also learn about the safety of the low-wattage holmium laser. The main questions it aims to answer are:
Is the low-power holmium laser effective at treating large and/or difficult bile duct or pancreatic duct stones? Is the low-power holmium laser effective safe to use in adults? How does the low-power holmium laser compare to electrohydraulic lithotripsy for the management of large and/or difficult bile duct or pancreatic duct stones.
Participants will:
Undergo ERCP procedure and their bile duct or pancreatic duct stone will either be broken up with the low-power holmium laser lithotripsy device or the electrohydraulic lithotripsy lithotripsy device.
Answer a call 30 days after the procedure to document symptoms and/or any side effects.
详细描述
This study aims to assess two main questions. 1: Whether low-wattage holmium:YAG laser lithotripsy (using the Quanta System Litho EVO device) is safe and effective in the management large and/or difficult bile duct or pancreatic duct stones. 2: Whether low-wattage holmium:YAG laser lithotripsy is non-inferior to electrohydraulic lithotripsy in the management of large and/or difficult gallstones.
Part one of the study will investigate whether utilizing the low-wattage holmium:YAG laser lithotripsy device via single-operator cholangioscopy (SOC-LL) is safe and effective to treat large and/or difficult choledocholithiasis or pancreaticolithiasis.
Part two of the study will be a non-inferiority study to determine if SOC-LL is non-inferior for stone clearance, among other secondary outcomes, compared to electrohydraulic lithotripsy via single-operator cholangioscopy (SOC-EHL).
Patients who meet the inclusion criteria will undergo ERCP procedures and will either undergo SOC-LL or SOC-EHL to treat their large and/or difficult choledocholithiasis or pancreaticolithiasis. Stone clearance and other procedural or safety measures will be assessed after the procedure. The patient will be monitored after the procedure for adverse events and the administration of medications or admission to the hospital will be determined by the proceduralist. Roughly 30 days after the procedure the patient will be called to assess for any adverse effects as well as to determine symptom resolution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-85 years
- •Signed written informed consent.
- •Presence of one or more biliary (common bile duct or intrahepatic) or pancreatic duct stones that are deemed "difficult" based on at least one of the following criteria:
- •Stone diameter ≥ 15 mm in any single dimension as measured on prior cross-sectional imaging (CT, MRCP, or EUS).
- •Presence of an impacted stone that cannot be dislodged with a standard balloon or basket.
- •Stone located proximal to a benign biliary or pancreatic duct stricture.
- •Documented failure of stone extraction during a prior ERCP attempt using standard techniques (e.g., sphincterotomy with balloon/basket extraction).
排除标准
- •Pregnancy: Repeated ERCP would be delayed until after delivery if possible
- •Clinically significant, uncorrectable coagulopathy (defined as INR > 1.5 or platelet count < 50,000/μL).
- •Surgically altered upper gastrointestinal anatomy that precludes conventional ERCP access (e.g., Roux-en-Y gastric bypass), unless an alternative access route (e.g., laparoscopy-assisted or EUS-directed) is planned as the standard of care.
- •Known or highly suspected malignant biliary or pancreatic stricture associated with the stone.
- •Acute pancreatitis at the time of screening, unless it is gallstone pancreatitis with persistent biliary obstruction, for which ERCP is therapeutically indicated.
- •Severe cardiopulmonary disease or other comorbidities that, in the judgment of the investigator, would make the patient an unsuitable candidate for a prolonged endoscopic procedure under general anesthesia.
- •Known life expectancy of less than 6 months.
- •Inability or unwillingness to comply with study procedures or follow-up requirements.
研究组 & 干预措施
Laser Lithotripsy
Laser lithotripsy (LL). Use of LL to break down large/difficult bile duct or pancreatic duct stones.
干预措施: Laser lithotripsy with low-wattage holmium laser (Device)
Electrohydraulic Lithotripsy
Electrohydraulic lithotripsy (EHL). Use of EHL to break down large/difficult bile duct or pancreatic duct stones.
干预措施: Electrohydraulic lithotripsy (Device)
结局指标
主要结局
Complete stone clearance
时间窗: Immediately after the procedure
Complete stone clearance is defined as the lithotripsy and clearance of ductal stone fragments as confirmed on cholangiogram or pancreaticogram at the end of the index/first procedure of the study.
次要结局
- Overall complete stone clearance rate(Immediately after the final procedure)
- Number of procedures(Immediately after the final procedure)
- Total procedure time(Immediately after the final procedure)
- Total lithotripsy time(Immediately after the final procedure)
- Rate of rescue mechanical lithotripsy(Immediately after the final procedure)
- Length of post-procedure hospital stay(Immediately after the final procedure)
研究者
Neal Ambrish Mehta
Assistant Professor
Rush University Medical Center