The Role of Cholangioscopy and Biliary Radio Frequency Ablation in the Management of Occluded Biliary Self-expanding Metal Stent.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Successful restoration of bile duct drainage
研究概览
简要总结
Primary Objective: To document state-of- the-art multi-modality management of occluded biliary SEMS aiming to minimize number of reinterventions while providing symptom relief without procedure-related serious adverse events.
NOTE: This study will be hypothesis-generating for an anticipated randomized controlled study (RCT) to compare outcomes of placement of a plastic stent inside the occluded SEMS to outcomes of the proposed multi-modality approach.
详细描述
Study Design:
Prospective, multi-center, single arm, post market, observational study
Two groups:
- Sludge group: SEMS occluded due to sludge/stones in SEMS
- Ingrowth/overgrowth group: SEMS occluded due to malignant tumor ingrowth or benign hyperplastic tissue overgrowth
Primary Endpoint:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- •Recurrent biliary obstructive symptoms after biliary SEMS placement
- •Biliary SEMS occlusion.
排除标准
- •Contraindications for endoscopic techniques
- •Ongoing cholangitis. NOTE: In case a patient presents who meets the inclusion and exclusion criteria, but has cholangitis, then a naso-biliary drain (NBD) will be placed before the ERCP until the cholangitis resolves.
研究组 & 干预措施
Sludge group
If Single operator cholangioscopy reveals only sludge then sludge will be cleared using conventional technique during ERCP.
干预措施: Single operator cholangioscopy, Endoscopic biliary RFA (Device)
Ingrowth / Overgrowth
If Single operator cholangioscopy reveals tumour ingrowth or overgrowth then to evaluate the role of biliary RFA for occluded stent due to tumour ingrowth or overgrowth
干预措施: Single operator cholangioscopy, Endoscopic biliary RFA (Device)
结局指标
主要结局
Successful restoration of bile duct drainage
时间窗: 1 month
Successful restoration of bile duct drainage with biliary obstructive symptom and cholangitis relief as applicable, without procedure related SAE'S, from procedure through 30 days followup.
次要结局
- Resolution of cholangitis(1 week and 1 month)
研究者
Mohan Ramchandani
Consultant Gastroenterologist
Asian Institute of Gastroenterology, India