Determinants of Technical Success and Safety in Therapeutic ERCP for Obstructive Jaundice: A Prospective Comparative Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Impact of type of anesthesia on technical success rate
研究概览
简要总结
compare the impact of type of anesthesia on ERCP including technical success, rate of complications, peri procedural safety, patient and endoscopist satisfaction in adult patients with obstructive jaundice
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
- None
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 old.
- •Patient with obstructive jaundice as an indication for therapeutic ERCP.
- •Provided written informed consent.
排除标准
- •Patients below 18 years old.
- •Indications for ERCP other than obstructive jaundice.
- •with coagulopathy not corrected prior to procedure.
- •severe active cardiopulmonary comorbidities.
- •Previous altered upper GIT anatomy (e.g gastric by-pass).
- •Pregnancy
研究组 & 干预措施
Group A
50 patient will under go procedure (ERCP) under general anesthesia (25 calcular obstructive jaundice ,25 malignant obstructive jaundice)
干预措施: ERCP (Procedure)
Group B
50 patient will under go procedure (ERCP)under sedation (25 calcular obstructive jaundice, 25 malignant obstructive jaundice)
干预措施: ERCP (Procedure)
结局指标
主要结局
Impact of type of anesthesia on technical success rate
时间窗: at the time of the procedure
Technical success rate defined as successful deep biliary cannulation and completion of the intended therapeutic intervention.
次要结局
- rate of procedure related complications(at the time of procedure up to 72 hours post procedure)
研究者
Mohamed Khaled Abdelazim
Resident doctor, Tropical Medicine and Gastroentrology
Sohag University