Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Therapeutic success
研究概览
简要总结
Although ampullary tumors are rare (representing 0.6-0.8 % of all digestive cancers), their estimated incidence has increased in recent years (<1 per 100 000 per year). Most noninvasive ampullary tumors of the major papilla occur as sporadic and asymptomatic lesions, detected during conventional upper endoscopy performed for another indication.
Nonetheless, they can present with jaundice (17%), pain (14%), pancreatitis (4%), cholangitis (1%), and can be associated with common bile duct stones (up to 38%). Resection of ampullary adenomas is warranted to prevent malignant progression. The most recent European Society of Gastrointestinal Endoscopy (ESGE) recommend endoscopic ampullectomy as the standard of care approach for ampullary adenomas without intraductal extension, due to excellent outcomes of technical and clinical success (high complete and curative resection rates of 94% and 87%, respectively), with lower morbidity and recurrence rates. This procedure as a low rate of mortality (of 0.4%), but the rate of adverse events can exceed 20%. The most frequent adverse events are acute pancreatitis (12%), intraprocedural and/or delayed bleeding (11%), perforation (3%), cholangitis (3%), ampullary stenosis (2.5%). Also there is a high recurrence rate of up to one third after endoscopic resection; up to two thirds are identified at the first follow-up endoscopy, requiring additional endoscopic resection or surgery.
详细描述
The relevance of the study is to assess the predictors for therapeutic success, adverse events and recurrence after endoscopic ampullectomy is of paramount importance to develop expertise in this challenging procedure.
The occurrence of adverse events after endoscopic ampullectomy carries a significant impact on the prognosis and recovery, possibly limiting a broader proficiency in this procedure. Thus, identifying significant predictors is crucial to more accurately select the patients and to evolve strategies to prevent and minimize the incidence and severity of adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patients (≥18 years) submitted to endoscopic resection of an ampullary adenoma with the following features were included:
- •lesions up to 30 mm (including with laterally spreading component)
- •with low-grade or high-grade dysplasia on preprocedural histology
- •with no intraductal extension
- •with no evidence of invasive malignancy on endoscopic assessment (including endoscopic features including hard consistency, friable or ulcera:ve surface and spontaneous bleeding)
- •A minimum follow-up period of one year afer endoscopic ampullary resection.
排除标准
- •Patients with lesions with the following features were excluded:
- •intraductal extension
- •evidence of invasive malignancy
- •other non-adenomatous lesions
- •Patients who underwent endoscopic resection or surgical ampullectomy prior to enrollment
- •Patients with a follow-up of less than a year after endoscopic ampullary resection
- •Patients with pancreas divisum.
结局指标
主要结局
Therapeutic success
时间窗: 1 year
- Rate of adenoma recurrence after endoscopic resection of ampullary adenomas
Safety outcomes
时间窗: 1 year
- Rate of adverse events related to endoscopic resection of ampullary adenomas
次要结局
- Prophylaxis(1 year)
- Risk factors(1 year)
研究者
Paulo Sérgio Durão Salgueiro
MD, PhD
Universidade do Porto
