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临床试验/NCT01408264
NCT01408264已完成4 期

A Prospective Randomised Trial of 0.025 Wire Guided Cannulation Versus Current Practice 0.035 Wire Guided Cannulation

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2010年8月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
184
试验地点
1
主要终点
Post-ERCP pancreatitis

研究概览

简要总结

The aim of this study is to determine whether using a smaller wire results in a higher success rate at endoscopic retrograde cholangiopancreatography (ERCP), and lower incidence of adverse events

详细描述

Cannulation of the bile duct is a prerequisite to successful therapeutic biliary endoscopy. Cannulation itself can carry substantial risk to the patient. Acute pancreatitis following ERCP can occur up to 5% of cases. The risk increases in patients with non dilated bile ducts, young age, known past history of pancreatitis and suspected sphincter of oddi dysfunction. During the procedure of ERCP, the number of pancreatograms also correlates with incidence of post ERCP pancreatitis. Hydrostatic pressure by contrast injection into the pancreatic duct may be the principal cause of pancreatitis. We performed a meta-analysis of randomized controlled trials that compared the technique of contrast guided to wire guide cannulation in achieving bile duct cannulation during ERCP and found that wire guide cannulation was better at the prevention of post ERCP pancreatitis. The use of a guide wire obviates the need for contrast injection. The current standard is the use of a 0.035" guidewire with a hydrophilic tip. We now postulate that the use of a 0.025" further reduces post-ERCP pancreatitis as a finer wire theoretically induces less trauma to the pancreatic orifice.

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
Single (Participant)

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

  • •All patients referred for ERCP who have an intact naïve papilla are considered for inclusion

排除标准

  • •Age <18yrs
  • •Acute illness (hypotension: BP<90mmHg, hypoxia: O2 <95%, haemodynamic instability)
  • •Inability or refusal to give informed consent.
  • •Patients with previous sphincterotomy
  • •Pancreatic or ampullary cancer are excluded as post-ERCP pancreatitis (PEP) is very uncommon in these subgroups and tumour-related anatomical variation may alter cannulation technique.
  • •(consider substratify results for this subgroup, but exclude if duodenal stenosis precludes an attempt on the papilla)
  • •Patients with surgically altered anatomy (Bilroth II gastrectomy and Roux en Y anastomosis) are excluded as cannulation technique is fundamentally different from that in normal anatomy.

研究组 & 干预措施

0.035 guidewire

Active Comparator

conventional 0.035 guidewire

干预措施: Conventional 0.035 guidewire (Device)

Olympus Visiglide 0.025 guidewire

Active Comparator

Olympus Visiglide 0.025

干预措施: Olympus Visiglide 0.025 guidewire (Device)

结局指标

主要结局

Post-ERCP pancreatitis

时间窗: 30 days after ERCP

Reported post-ERCP pancreatitis

次要结局

  • Abdominal pain(30 days after ERCP)
  • Prolonged hospitalisation(30 days after ERCP)
  • Death(30 days after ERCP)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Yun-wong Lau

Professor

Chinese University of Hong Kong

研究点 (1)

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