Endoscopic sphincterotomy with large balloon dilatation (ESLBD) versus endoscopic sphincterotomy (ES) alone for predicted difficult choledocholithiasis: a randomized controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Success rate defined as proportion of patients achieving complete removal of CBD calculus confirmed by cholangiogram at the end of the procedure
研究概览
简要总结
It is a Randomized controlled trial that will be conducted in the ERCP suite Division of Gastroenterology school of digestive and liver disease Institute of Post Graduate Medical Education and Research Kolkata India. This study will be an open label non inferiority parallel group 1:1 allocation randomized controlled clinical trial to assess the efficacy and safety of ESLBD versus ES for CBD clearance in patients with choledocholithiasis of size greater than 10mm and or greater or equal to 1 in number and undergoing index ERCP and it will be conducted in between October 2024 to March 2026. In each group sample size will be 54 making total of 108. Candidates will be selected as per Inclusion and exclusion criteria and will get randomized. After ES or ESLBD conventional extraction balloon trawled and stone will be removed from the bile duct. Mechanical lithotripsy will be used as rescue therapy in each group. Primary outcome of this study will be to determine Success rate that will be defined as per clearance achieved at the end of the procedure and secondary outcomes will be to know the incidence of post procedural complications in each group along with to determine the procedure time for each group. For the complications each individual will be followed for 24 hours 48 hours 7 days and 14 days. at the end of the study statistical analysis will be recorded in standard pre-defined proformas. Collected data will be entered in MS Excel sheet and analyzed by using SPSS statistics software. For analysis of categorical data chi square test will be used. For analysis of continuous variables Mann Whitney test will be used and for paired samples Wilcoxon rank sum test will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults greater than 18 years old with radiologically ( Ultrasound and or MRCP) confirmed Choledocholithiasis of size equal to or greater than 10mm and or more than one in number undergoing ERCP for the first time Ability to provide informed consent.
排除标准
- •Those with previous Biliary Sphincterotomy and or biliary stent in situ Those with recurrent choledocholithiasis after previous endoscopic choledocholithiasis clearance Patients having one or more choledocholithiasis with shortest transverse diameter greater than 15mm Patients having impacted CBD calculus with relatively narrower CBD distal to the calculus on pre ERCP MRCP Patients with Mirrizi syndrome Patients with suspected biliary ascarisis Patients having a stricture benign or malignant distal to the CBD calculus Patients with ongoing Acute pancreatitis Pancreatic head mass Ongoing hypotension including those with sepsis Patients with ongoing severe cholangitis as evidenced by the presence of one or greater organ dysfunction according to Tokyo guidelines Pregnant women Patients with significant renal illness like dialysis dependent Patients with recent or past variceal bleeding uncontrolled ascites persistent hepatic encephalopathy and severe coagulopathy INR greater than 3 Patients with acute liver failure and or acute on chronic liver failure Patients with recent Cerebrovascular accident and or Transient ischemic attack Patients on anti coagulants and or clopidogrel that cannot be stopped temporarily standard contraindications to ERCP Unwillingness or inability to consent for the study.
结局指标
主要结局
Success rate defined as proportion of patients achieving complete removal of CBD calculus confirmed by cholangiogram at the end of the procedure
时间窗: end of procedure 2 hours
次要结局
- Complication rates Incidence of post procedural pancreatitis infections bleeding perforation and other adverse events
研究者
Dr Akanksha Srivastava
IPGMER and SSKM Hospital, Kolkata