跳至主要内容
临床试验/NCT06648746
NCT06648746尚未招募不适用

Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy

Universidade do Porto0 个研究点目标入组 100 人开始时间: 2024年12月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paulo Sérgio Durão Salgueiro

MD, PhD

Universidade do Porto

相似试验