NL-OMON56974尚未招募不适用
eedle-knife fistulotomy (NKF) for primary biliary access in patients with choledocholithiasis; a *real world* prospective multicenter pilot study - INCISIO
Amsterdam UMC0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patients with an indication for ERCP with sphincterotomy (e.g.
- •choledocholithiasis)
- •- Sedation with administration of propofol or general anesthesia during ERCP
- •- Naive papilla
- •- Capable of written informed consent
- •- Age >= 18 years
排除标准
- •- Low risk of pancreatitis: (1) definite chronic pancreatitis according to
- •M-ANNHEIM criteria
- •(15), (2) previous sphincterotomy, and (3) routine biliary stent exchange. In
- •case of a pancreatic duct intervention, chronic pancreatitis and previous
- •sphincterotomy are not exclusion criteria
- •- Acute pancreatitis, according to the Atlanta classification
- •- Altered anatomy (defined as anatomical variations in which bile and/or
- •pancreatic secretions (in case of pancreatic duct interventions) do not enter
- •the duodenum by way of the ampulla of Vater (e.g., Roux-en-Y reconstruction,
- •surgery for chronic pancreatitis)
- •- Pregnancy
- •- Severe liver disease (ascites)
- •- Contraindications for rectal NSAIDs, including allergy, active
- •gastrointestinal bleeding, ulcer disease, renal insufficiency (glomerular
- •filtration rate < 30 mL/min) and NSAID use for other indications (other than
- •cardioprotective aspirin)
- •- Coagulopathy or anticoagulant use, except for antiplatelet monotherapy
- •- Type I (flat papilla without oral protrusion) and type IIIA (papillary
- •orifice inside the diverticulum) according to the Viana classification (18),
- •and all others without an intraduodenal segment
- •- Active cholangitis
研究者
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