Endoscopic Retrograde Cholangiopancreatography With and Without Endoscopic Ultrasound Guided Hepaticogastrostomy for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Technical success
研究概览
简要总结
A prospective randomized clinical trial to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced malignant hilar biliary obstruction. The primary outcome will be technical success, clinical success, procedural duration, and re-interventions. Secondary outcomes will be the rate of adverse events. patients will be followed up at 1 and 3 month intervals
详细描述
Bilateral stenting by Endoscopic Retrograde Cholangiopancreatography in malignant hilar biliary obstructions (MHBO) is challenging and technically difficult. EUS hepaticogastrostomy (EUS-HGS) has been increasingly used as an alternative method to achieve internal biliary drainage in MHBO. Because of the difficulty of ERCP in such scenario, the combination of EUS-HGS and ERCP provides a possible chance of longer stent patency with less event of stent clogging Aim of the work: to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced MHBO.
The inclusion criteria will be presence of inoperable MHBO with elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal The study patients will be randomized in 1:1 ratio to: ERCP biliary drainage (ERCP-BD) group: bilateral metallic stents insertion will be attempted by transpapilary approach. Combined ERCP and EUS-HGS group: unilateral metallic stent will be inserted on right side by transpapilary approach and a transmural stent will be inserted on left side by EUS.
technical success, clinical success, procedural duration, and re-interventions and adverse events will be assesed
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
- Double (Participant, Investigator)
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
- •Presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography bismuth type III & IV only.
- •Histologically confirmed malignant hilar biliary obstruction.
- •Elevated serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
- •Absence of duodenal narrowing/obstruction.
- •Accept sharing in the study
排除标准
- •Pregnancy.
- •Distal biliary obstruction as the main lesion.
- •Benign biliary stenosis.
- •Malignant hilar biliary obstruction bismuth type I and II.
- •Presence of duodenal obstruction.
- •Surgically altered anatomy or inability to access the major duodenal papilla.
- •Patients underwent previous intervention for biliary drainage.
- •Previously failed biliary cannulation at ERCP.
- •Large volume ascites.
- •Patients unfit for anesthesia.
- •Patients having uncorrectable coagulopathy or thrombocytopenia.
- •History of allergy to radiocontrast agents.
- •Refuse sharing in the study.
结局指标
主要结局
Technical success
时间窗: during the procedure
considered after stent placement (expanded and patent) with good bile flow and drainage
Procedural duration
时间窗: at the end of the procedure
defined as time from biliary cannulation to stent placement by ERCP, and time from needle puncture of the dilated bile duct to stent placement by EUS
Clinical success
时间窗: 3 month
considered at 2 weeks by a 50% decrease in total bilirubin levels from baseline and at 4 weeks if total bilirubin is less than 3mg/dL.
Re-interventions
时间窗: 3 month
need for re-intervention to secure biliary drainage
次要结局
- Adverse events(3 month)