Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis (SupraBilS): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Time-to-Stent disfunction
研究概览
简要总结
This is a randomized controlled trial comparing patients with obstructive jaundice due to malignancies of the perihilar area of bile ducts and undergoing both preoperative and palliative biliary drainage. The comparison will focus on the technique:, on the one hand, an arm of patients undergoing standard-of-care ERCP with trans-papillary plastic protesis placement, and on the other hand, an experimental arm of patients undergoing suprapapillary plastic protesis placement with no sphincterotomy. The primary objective will be to compare the time-to-stent dysfunction in the two groups; secondary objectives will include a comparison of the safety, technical, and clinical success of the procedures.
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
- •Radiological/ biochemical/pathological diagnosis of malignant OJ.
- •Stenosis maximum extent may be 2 cm after biliary confluence.
- •Documented obstructive jaundice (serum bilirubin > 3 mg/dL).
- •Indication for biliary drainage (preoperative or palliative).
- •Age ≥ 18 years.
- •Signed informed consent.
排除标准
- •Contraindications to endoscopic approach (duodenal stenosis, surgically altered anatomy).
- •Previous sphincterotomy or drainage.
- •Involvement of the papilla of Vater by the tumour.
- •Uncontrolled coagulopathy (INR > 1.5 uncorrectable or <50.000 PLTs).
- •Ongoing uncontrolled cholangitis as defined according to the Tokyo 2018 Guidelines, or systemic sepsis.
研究组 & 干预措施
Suprapapillary
ERCP for malignant stenosis of bile duct with suprapapillary stents positioning (experimental)
干预措施: ERCP with suprapapillary stent placement (Procedure)
Trans Papillary
ERCP for malignant stenosis of bile duct with transpapillary stents positioning (Standard of care).
干预措施: ERCP with transpapillary stent placement (Procedure)
结局指标
主要结局
Time-to-Stent disfunction
时间窗: From index procedure to a minimum of one year of follow up.
In days, calculated from the index procedure. Stent(s) dysfunction, which includes occlusion or migration of the stent(s) and tumour ingrowth/overgrowth, is defined as the presence of at least two of the following three criteria: 1. New dilation of the biliary tree on imaging: 2. Bilirubin level above 2 mg/dL (34.2 mmol/L) with a new increase ≥ 1 mg/dL compared with the value after initial clinical success, or elevation of alkaline phosphatase and/or g-glutamyl transferase greater than 2 times the upper normal limit with a new elevation of 30 U/L 3. Cholangitis, characterized by fever along with leucocytosis (\> 10,000/mL) or C-reactive protein levels above 20 mg/dL.
次要结局
- Safety of the procedure(From the index procedure within 14 days.)
- Technical success(At the moment of index procedure.)
- Clinical Success(Between 14 and 30 days from the index procedure.)
研究者
Andrea Ruzzenente
Professor
Azienda Ospedaliera Universitaria Integrata Verona