“FULLY COVERED SEMS VS MULTIPLE PLASTIC STENTS VS COMBINED STENTS TO TREAT BENIGN BILIARY STRICTURES : A MULTICENTRIC RANDOMISED CONTROLLED TRIAL (COMBS TRIAL)”
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 3
研究概览
简要总结
Endoscopy has become the preferred option for treating benign
biliary stricture (BBS). ESGE recommends temporary insertion
of either multiple plastic stents or a fully covered
SEMS(FCSEMS) for treatment of benign biliary strictures. The
choice between the two strategies depends on the etiology of the
stricture, its location, the CBD diameter, and the endoscopist’s
experience.
The study primarily aims to statistically evaluate and compare
the safety profile and complication rates in all the three groups
throughout the study period. The study secondarily also aims to
compare the biliary stricture resolution 2 years after initial
stent(s)placement defined as the absence of re-stenting after the
stenting period and 2 years serum alkaline phosphatase (ALP)
level not exceeding twice the level at the end of stenting period, technical success and
treatment failure of stent placement, number of endoscopic
retrograde cholangiopancreatography (ERCP) procedures
during 2 years after initial stent placement, total number of
stents placed during the study and duration of stent placement
procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group.
- •greater than or equal to 18 years 2)Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice {Total bilirubin greater than or equal to 2.5mg/dl} for at least 1 month or persistent cholestasis associated with at least 3 times normal alkaline phosphatase levels) documented at time of enrolment for naive stricture or at the time of prior plastic stent placement in strictures that had 1 prior plastic stent inserted 3)Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts. 4)Benign etiologies like chronic pancreatitis, post cholecystectomy and idiopathic.
排除标准
- •Malignant bile duct stricture 2)A prior biliary metal stent or more than 1 plastic stent for 6 months 3)Stricture within 2 cm of common bile duct bifurcation 4)Portal cavernous cholangiopathy, 5)Known bile duct fistula or leak, 6)Symptomatic duodenal stenosis with gastric stasis, 7)Contraindication to endoscopic techniques or devices, 8)Refusal to consent.
研究者
Dr Ashok Jhajharia
Sawai Man Singh Medical college