Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study (ERASE-pilot)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety (rate of adverse events)
研究概览
简要总结
Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed. It is hypothesized that the curative resection rate can be increased and recurrence prevented by using a combination of snare tip soft coagulation (STSC) of the resection margins and thermal ablation by cystotome of the biliary orifice in patients with and without the suggestion of intraductal extension.
Therefore, aim of this study is to assess the safety and feasibility of endoscopic papillectomy combined with thermal ablation of the biliary orifice by cystotome and STSC of the lateral resection margins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Papillary adenoma which seems suitable for curative endoscopic resection.
- •18 years or older.
- •Capable of providing written and oral informed consent.
排除标准
- •Patients with intraductal extension of >1 cm beyond the duodenal wall or adenocarcinoma will be excluded since surgical resection is considered the preferred treatment in these cases.
- •Failure to place a PD stent in patients with normal pancreatic duct anatomy.
- •Refusal to provide informed consent.
研究组 & 干预措施
Intervention
干预措施: Thermal ablation of resection margins by STSC and biliary orifice by cystotome. (Other)
结局指标
主要结局
Safety (rate of adverse events)
时间窗: During 9 months follow-up
i.e. pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis.
次要结局
- Curative resection rate(3 and 9 months)
- Additional yield of EUS prior to resection.(Prior to intervention.)
- Effect of hemospray as first modality in case of post procedural bleeding in need of intervention.(Delayed bleeding is expected not more than 30 days after the procedure)
- Individual components of the primary outcome.(During 9 months follow-up)
研究者
Rogier P. Voermans
R.P. Voermans MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
