Prophylactic Endoscopic Sphincterotomy in Patients Unfit for Cholecystectomy After an Acute Biliary Pancreatitis Episode - an Open-label, Two-armed, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 92
- 主要终点
- Recurrent pancreatobiliary events
研究概览
简要总结
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of prophylactic endoscopic sphincterotomy (ES) in frail patients unfit for cholecystectomy following an episode of acute biliary pancreatitis (ABP).
Eligible patients will be randomized in a 1:1 ratio to either prophylactic ES during the index admission or conservative treatment. The primary endpoint is the time from randomization to the first occurrence of a recurrent pancreatobiliary event within 12 months, including recurrent ABP, cholangitis, choledocholithiasis requiring endoscopic retrograde cholangiopancreatography (ERCP), or cholangiogenic liver abscess. Secondary outcomes include mortality, pancreatobiliary events requiring intensive care unit admission, post-ERCP complications, cholecystitis, and length of hospitalization.
A total of 92 patients will be enrolled. The trial will be led by the Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary, and conducted in accordance with Good Clinical Practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •adult patients (above 18 years)
- •naïve papilla
- •evidence of AP based on the Atlanta criteria:
- •pain in the upper abdomen
- •serum amylase or lipase concentration > 3 times the upper limit of normal
- •imaging features of acute pancreatitis on abdominal imaging
- •high probability of a biliary etiology:
- •gallstones or biliary sludge on imaging (any type)
- •dilated common bile duct on imaging defined as > 8 mm in patients ≤ 75 years or > 10 mm in patients > 75 years
- •abnormal liver enzymes (alanine aminotransferase [ALT] two times the upper limit of normal)
- •patients unfit for surgery due to the attending physician's decision e.g. American Society of Anesthesiologists (ASA) class ≥ III; severe heart failure with reduced ejection fraction <40%, severe uncontrolled hypertension, chronic kidney disease stage four or five
排除标准
- •previous cholecystectomy
- •previous endoscopic sphincterotomy or pancreatobiliary stenting
- •ERCP/ES is recommended by the guidelines (3)
- •sign of cholangitis
- •presence of CBD stone on any imaging
- •signs of stone in endoscopic ultrasonography or magnetic resonance imaging in case of abnormal liver enzymes (persistently elevated ALT and aspartate aminotransferase (AST) with less than a 20% decrease over four days) or dilated CBD (defined as above)
- •chronic pancreatitis
- •estimated life expectancy < 12 months
- •ERCP is contraindicated, e.g. the procedure cannot be carried out safely due to the patient's comorbidities or physical status; high risk of bleeding or contraindication of the discontinuation of the anticoagulation therapy.
- •ERCP is technically not feasible due to altered anatomy, e.g., total gastrectomy, Roux-en-Y gastric bypass anatomy
- •pancreatobiliary malignancy
研究组 & 干预措施
Prophylactic endoscopic sphincterotomy
Papillary cannulation and sphincterotomy techniques will be performed in adherence to the recommendations outlined in the ESGE (European Society of Gastrointestinal Endoscopy) guideline. All recommended measures for post-ERCP (Endoscopic Retrograde Cholangiopancreatography) pancreatitis prevention must be implemented, including the use of prophylactic pancreatic stents, rectal nonsteroidal anti-inflammatory drugs, and optimal hydration protocols where appropriate.
All rescue techniques may be utilized if necessary, in accordance with clinical judgment and guideline recommendations.
ERCP/ES (endoscopic sphincterotomy) will be performed by an experienced endoscopist, defined as someone who has performed more than 300 ERCPs in their lifetime and maintains a native papilla cannulation success rate of at least 90%.
If the ES cannot be performed during the initial ERCP, the number of further attempts is under the discretion of the endoscopist.
干预措施: Prophylactic endoscopic sphincterotomy (Procedure)
Conservative treatment
This study arm will follow a conservative treatment strategy, and no endoscopic procedures will be performed.
结局指标
主要结局
Recurrent pancreatobiliary events
时间窗: 1 year
Composite time-to-first-event endpoint including: * cholangitis - Tokyo guidelines * recurrent acute biliary pancreatitis - revised Atlanta criteria * choledocholithiasis - imaging/ERCP confirmation * cholangiogenic liver abscess - imaging plus clinical diagnosis
次要结局
- Number of participants with recurrent acute biliary pancreatitis, cholangitis, choledocholithiasis, or cholangiogenic liver abscess (individual components of the composite primary outcome)(At 3, 6, 9, and 12 months.)
- Length of hospitalization(From enrollment to one month.)
- Pancreatobiliary events requiring intensive care unit admission(At 3, 6, 9, and 12 months.)
- Mortality associated with pancreatobiliary events(At 3, 6, 9, and 12 months.)
- All-cause mortality(At 3, 6, 9, and 12 months.)
- Acute cholecystitis(At 3, 6, 9, and 12 months.)
- Post-endoscopic retrograde cholangiopancreatography pancreatitis(Peri-procedural.)
- Other endoscopic retrograde cholangiopancreatography-related complications(Peri-procedural.)