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临床试验/NCT03494543
NCT03494543已完成不适用

Endoscopic Papillectomy for Ampullary Adenomas: an Italian Single Centre Experience

Azienda USL Reggio Emilia - IRCCS0 个研究点目标入组 62 人开始时间: 2005年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
主要终点
technical success

研究概览

简要总结

In this single-center experience we retrospectively evaluated principal clinical outcomes of endoscopic papillectomy in all patients referred to our unit. The same evaluation was then performed dividing sproradic ampullary adenoma from familial adenomatous polyposis associated adenomas, and resulting outcomes were compared.

详细描述

INTRODUCTION Ampullary adenomas are rare tumors of digestive tract with a prevalence of 0.04% to 0.12%, but represent a large part of small intestinal neoplasms. They can origin from the duodenal epithelium or from the pancretobiliary one; the latter seems to have a worse prognosis in terms of nodal metastasis and local invasion with lower long term survival. In these kinds of lesion the adenoma-to-carcinoma sequence has been demonstrated, as already described in the colon.

Symptoms are variable and often are due to the growth of the lesion that can cause pancreatico-biliary obstruction, leading to jaundice and pancreatitis, gastric outlet obstruction, leading to sub-occlusive syndrome or nonspecific abdominal pain, and, rarely, bleeding. Commonly ampullary adenomas are asymptomatic and are discovered during esophagogastroduodenoscopy performed for several symptoms, such as dyspepsia and reflux syndrome, or during endoscopic screening in patients with familial adenomatous polyposis (FAP).

FAP is an autosomal dominant disease caused by mutation in the adenomatous polyposis coli (APC) genes. FAP patients develop colonic polyps in over 90% by age 35 years, while the duodenum is the second most common site of polyp formation. Duodenal/ampullary cancer is the second cause of cancer death in FAP and the risk of development it is 100- to 300-fold higher than the general population and is measured with the Spigelman score that ranges between stage I and IV on the basis of duodenal polyp number, size, histology and grade of dysplasia.

Considering the malignant potential of these lesions, above all in sporadic ampullary adenomas (SAA), complete excision is indicated. Otherwise, in patients with FAP the risk of adenoma to adenocarcinoma transformation seems to be lower and the need of resection is controversial. In the other hand management with annual or biennial surveillance, because of the documented stability of the situation, is suggested only in FAP patients when just minimal irregularity of the papilla is found and low-grade dysplasia was detected.

In the past years pancreatoduodenectomy or transduodenal resection, on the basis of the local invasion and of the local expertise, were the standard treatment, but these approach were burdened by high mortality and morbidity rates. In the last years case reports, retrospective and prospective series have demonstrated the feasibility and safety of the endoscopic resection for benign ampullary adenoma and for early stage ampullary carcinoma with not only diagnostic but also curative intent. Success rate of the endoscopic papillectomy (EP) ranges from 46 to 92% and recurrence rate from 0 to 33% and, recently, the same efficacy with low morbidity respect of surgery have been reported.

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

  • Patients with diagnosis of ampullary adenoma on the endoscopic resection specimen and with at least 24 months of follow-up were included in the analysis

排除标准

  • Patients taht underwent endoscopic papillectomy without a diagnosis of adenoma or adenocarcinoma in the specimen

结局指标

主要结局

technical success

时间窗: 24 months

The primary outcome of the study was the technical success of endoscopic papillectomy, considered as achieved when all the following criteria were met: a) complete removal, even in multiple sessions b) absence of residues at histology (histology \<= pT1) at the first follow-up; c) recurrence successful treated by endoscopy (not surgery). Technical failure of EP was considered when at least one of the following criteria was met: a) histology\> pT1; b) residual adenomatous tissue not suitable of endoscopic resection; c) recurrence treated by surgery

次要结局

  • incidence of recurrence(24 months)
  • concordance of histology pre- and post endoscopi papillectomy(24 months)
  • number of procedures to achieve technical success(24 months)
  • incidence of adverse events(24 months)

研究者

发起方
Azienda USL Reggio Emilia - IRCCS
申办方类型
Other Gov
责任方
Sponsor

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