Comparison of Outcomes in Patients Undergoing Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) Using Duodenoscope With Single-use Distal Cover and Conventional Reusable Duodenoscope: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 319
- 试验地点
- 1
- 主要终点
- Number of Participants With Procedure-related Adverse Events
研究概览
简要总结
The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.
详细描述
The risks associated with the ERCP procedure will be explained to patients who meets the eligibility criteria. Consenting patients will be randomized to undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either (1) a duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope. Assessments will be made during, and immediately after the procedure, then patients will be called after 1 week, 1 month, and 3 months after the procedure to get information about adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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 undergoing ERCP for biliary and pancreatic conditions
- •Age > 18 years old
排除标准
- •Vulnerable patient groups including pregnant women
- •Patients who are unable to consent
- •Patients with known cholangitis
- •Patients with known Carbapenem-Resistant Enterobacteriaceae (CRE) or any other multi-drug resistant organisms (MDRO) infection
- •Surgically altered anatomy except for Billroth I
研究组 & 干预措施
Duodenoscope with single-use distal cover
Patients will undergo ERCP using a duodenoscope with a single-use distal cover
干预措施: Duodenoscope with single-use distal cover (Device)
Conventional Duodenoscope
Patients will undergo ERCP using a conventional duodenoscope
干预措施: Conventional duodenoscope (Device)
结局指标
主要结局
Number of Participants With Procedure-related Adverse Events
时间窗: 3 months
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes were assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient.
次要结局
- Duodenoscope Maneuverability: Intubation Into Esophagus(Maneuverability will be assessed only during the procedure (approximately 10 minutes))
- Duodenoscope Maneuverability: Passage Into Stomach(Maneuverability will be assessed only during the procedure (approximately 10 minutes))
- Duodenoscope Maneuverability: Navigation Across Pylorus(Maneuverability will be assessed only during the procedure (approximately 10 minutes))
- Duodenoscope Maneuverability: Achieving Short Position of the Scope(Maneuverability will be assessed only during the procedure (approximately 10 minutes))
- Duodenoscope Imaging Characteristics Profile: Image Quality(Imaging characteristics were assessed only during the procedure (approximately 15 minutes))
- Duodenoscope Maneuverability: Achieving Optimal Papillary Position(Maneuverability will be assessed only during the procedure (approximately 10 minutes))
- Duodenoscope Mechanical Characteristics Profile: Scope Stiffness(Mechanical characteristics assessed only during the procedure (approximately 15 minutes))
- Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality(Mechanical characteristics assessed only during the procedure (approximately 15 minutes))
- Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency(Mechanical characteristics assessed only during the procedure (approximately 15 minutes))
- Duodenoscope Mechanical Characteristics Profile: Hand Strain(Mechanical characteristics assessed only during the procedure (approximately 15 minutes))
- Duodenoscope Imaging Characteristics Profile: Image Stability(Imaging characteristics were assessed only during the procedure (approximately 15 minutes))
- Number of Participant With Procure Success (Ability to Perform Interventions)(30-60 minutes)
研究者
Subhas Banerjee
Professor of Medicine
Stanford University