跳至主要内容
临床试验/CTRI/2017/07/008957
CTRI/2017/07/008957尚未招募不适用

A Prospective evaluation of preoperative biliary drainage using Endoscopic ultrasound guided hepato-gastrectomy in distal malignant biliary obstruction

Endoscopy Research foundation1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年10月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
16
试验地点
1
主要终点
To study the technical & clinical success and immediate complications of preoperative biliary drainage by EUS-HGS in patients with distal malignant biliary obstruction

研究概览

简要总结

Preoperative biliary drainage in distal malignant biliary obstruction is considered to decrease jaundice prior to delayed curative surgery. Present rationale is biliary drainage using ERCP and biliary stenting. Some studies favours direct surgery rather than preoperative drainage, but have certain limitations. Biliary stenting can be done either with plastic or covered metal stent. However, covered metal stents have added advantages such as decrease risk of bleeding, pancreatitis, frequent stent block prior to surgery and are retrievable.

EUS-guided biliary drainage (EUS-BD) is an established alternative technique to unsuccessful endoscopic retrograde cholangio-pancreaticography (ERCP) in patients with malignant biliary obstruction.  Recent study establishes the short term outcome and complications comparable between EUS-BD and ERCP. In addition complication like pancreatitis was frequent in ERCP than EUS-BD.   Among different methods of EUS guided biliary drainage, EUS guided hepatogastric stenting  (EUS-HGS) showed more technical and clinical success with comparable complication rate. EUS-HGS has certain advantages over conventional biliary drainage. Firstly challenging step of antigrade guidewire passage both in rendezveous & antegrade stenting is avoided. Secondly, it is more physiological in patients with altered anatomy (congenital or altered) as it requires less repeated puncture.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1Willing and able to comply with the study procedures and provide written informed consent to participate in the study 2Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and ampullary cancers 3Biliary obstructive symptoms or signs 4Bilirubin level > 2 mg/dl 5Patients deemed as resectable by pancreatic protocol CT or MRI 6Surgery intent within 4 weeks.

排除标准

  • 1Biliary strictures caused by confirmed benign tumors 2Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and ampullary cancers.
  • 3Hilar stricture or obstruction due to any cause.
  • 4Neoadjuvant chemotherapy for current malignancy 5Palliative indication due to reasons other than surgical candidate status 6Previous biliary drainage by ERCP/PTC 7Patients for whom endoscopic techniques are contraindicated 8Participation in another investigational trial within 180 days 9Pregnancy.

结局指标

主要结局

To study the technical & clinical success and immediate complications of preoperative biliary drainage by EUS-HGS in patients with distal malignant biliary obstruction

时间窗: 2, 4, 6, 8 weeks follow up

次要结局

  • After EUS-HGS in postoperative period (after surgery) to study(1Length of hospital stay after surgery)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

Loading locations...

相似试验

To evaluate a new technique of drainage of bile... | 临床试验