Analysis of the Effectiveness and Safety of Endoscopic Retrograde Cholangiopancreatography Versus Percutaneous Transhepatic Biliary Drainage in Severe Acute Cholangitis Caused by Common Bile Duct Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Length of Hospital Stay
研究概览
简要总结
This study is a prospective, randomized controlled trial designed to compare the effectiveness and safety of endoscopic retrograde cholangiopancreatography (ERCP) with percutaneous transhepatic biliary drainage (PTBD) for the treatment of severe acute cholangitis caused by common bile duct stones. The primary goal is to determine which emergency drainage procedure leads to faster patient recovery, specifically by evaluating the length of hospital stay, without increasing complication rates.
详细描述
Severe acute cholangitis (AC) due to common bile duct stones is a life-threatening condition requiring urgent biliary decompression. While both ERCP and PTBD are established minimally invasive options, the optimal choice remains under discussion. This single-center, prospective, randomized controlled trial was conducted to compare these two interventions. A total of 126 patients with severe AC (Tokyo Guidelines 2018 Grade II or III) were randomized to either the ERCP group (n=63) or the PTBD group (n=63). Randomization was performed using a computer-generated sequence with concealed allocation. While operators could not be blinded, outcome assessors and data analysts were. The study hypothesis is that ERCP, as a more direct route for potential stone removal and drainage, may facilitate a quicker overall recovery compared to PTBD. The trial evaluates procedural outcomes, recovery metrics, therapeutic efficacy, inflammatory markers, and safety profiles to provide evidence for clinical decision-making.
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 (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 who met the diagnostic criteria for acute cholangitis according to the Tokyo Guidelines 2018 (TG18), and were diagnosed through physical examination, ultrasound, CT, or MRCP showing common bile duct stones as the cause of obstruction.
- •Body temperature <36°C or >38°C.
- •Presence of jaundice or signs of organ dysfunction (e.g., hypotension responsive to fluids for Grade II, or requiring vasopressors for Grade III, altered mental status, etc.).
- •Patients who signed informed consent.
排除标准
- •Patients with concurrent diseases such as gastric perforation or active gastrointestinal bleeding unrelated to cholangitis.
- •Patients with acute pancreatitis as the primary diagnosis.
- •Patients with serious primary diseases in the heart, brain, lungs, kidneys, hematopoietic, or nervous systems contraindicating either procedure.
- •Pregnant or breastfeeding women.
- •Patients with cognitive dysfunction unable to provide consent.
- •Known pancreatobiliary malignancy as the cause of obstruction.
- •Severe liver cirrhosis (Child-Pugh C) or liver atrophy.
- •Patients with severe systemic primary diseases, who could not tolerate the anesthesia or procedure.
- •Patients with mental disorders, hematologic diseases (e.g., severe coagulopathy uncorrectable pre-procedure), autoimmune diseases directly impacting biliary system, or those using high-dose corticosteroids affecting inflammatory markers.
- •Patients participating in other clinical drug trials.
- •Previous ERCP or PTBD for the current episode of cholangitis.
结局指标
主要结局
Length of Hospital Stay
时间窗: At hospital discharge (up to approximately 3-4 weeks post-procedure).
The total number of days from hospital admission to discharge.
次要结局
- Time to First Ambulation(From date of procedure until hospital discharge (estimated maximum of 4 weeks).)
- Procedure Time(Measured intraoperatively)
- Time to Return of Bowel Function(From date of procedure until hospital discharge (estimated maximum of 4 weeks).)
- Therapeutic Efficacy(Assessed at 24 hours post-procedure.)
- Change in Inflammatory Markers(Baseline (pre-treatment), 72 hours post-procedure, and 3 months post-treatment.)
- Change in Pain Intensity(Baseline (pre-treatment), 72 hours post-procedure, and 3 months post-treatment.)
- Incidence of Complications(up to 3 months post-procedure.)
研究者
Liping Zhu
Principal Investigator
Wuhan Integrated Traditional Chinese and Western Medicine Hospital