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临床试验/NCT03471403
NCT03471403招募中不适用

Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis

Western Sydney Local Health District1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Number of serious and non-serious adverse events

研究概览

简要总结

The purpose of this study is to collect prospective observational data regarding patients with diagnosed Familial Adenomatous Polyposis (FAP) undergoing cold snare polypectomy for duodenal adenomas

详细描述

Familial adenomatous polyposis (FAP) is a autosomal dominant disorder, secondary to a germ-line mutation in the tumour suppressor gene and characterised by multiple colorectal polyps (>100). Typically colorectal adenomas develop in the second and third decade of life. As a result these patients require an endoscopic colonic surveillance program, especially for at-risk family members, which usually begins in the 2nd decade of life starting with annual flexible sigmoidoscopies. The lifetime risk of colorectal cancer (CRC) is 100 percent, if left untreated and patient usually develop CRC in the 4th-5th decade of life. The patient's thus usually progress to a total colectomy.

FAP is also associated with adenomas in the upper gastrointestinal tract and is in nearly 90% of patients with FAP by age 70.Upper gastrointestinal tract screening with gastroscopies commences usually from 25-30 years of age. Usually a duodenoscopy is performed simultaneously to assess for ampullary adenomas. Although surgical procedures have been shown to be effective and have changed the natural history of colorectal cancer in FAP the management of duodenal adenomatosis remains a challenge. The prevalence of FAP associated duodenal adenomas has led to the development of Spigelman classification which assigns surveillance intervals by dividing patient's into four group based on size, histology and severity of dysplasia on histology7. Local endoscopic therapy options available for duodenal adenomatosis include; snare polypectomy, thermal ablation (using a mono/bipolar current) and laser coagulation each with their own limitation. Endoscopic intervention is usually recommended for Spigelman stage II and III disease.

Duodenal endoscopic mucosal resection (EMR) has been shown to be safe and effective methods in removing flat duodenal adenomas in FAP as observed in small case series. However as with colonic EMR these patient's automatically are placed in a higher risk group with the feared complications of delayed bleeding (per and post procedure) and perforation, with the former being as high as 10-15%. The bleeding risk is especially increased in the duodenum due to the rich vascularity of the sub-mucosal layer.

Cold snare polypectomy (CSP) has been shown to be a safe and effective method for removing diminutive colorectal polyps (<8mm) as compared to conventional polypectomy/endoscopic mucosal resection (EMR).

A small case series published the use of a hybrid technique, for duodenal adenomas, where a submucosal injection is performed underneath the lesion to separate the mucosa from the larger sub-mucosal vessels from which bleeding risk is thought to arise. By then performing cold snare piece-meal polypectomy and avoiding the need for thermal therapy risk of delayed bleeding associated is significantly reduced as compared to conventional EMR.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient's diagnosed with a confirmed diagnosis of FAP (genetic testing) and able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
  • Patients already commenced on endoscopic surveillance for FAP.

排除标准

  • Patient's with known strictures/stenosis
  • Pregnancy
  • Patients who did not consent to study
  • Bleeding diathesis

结局指标

主要结局

Number of serious and non-serious adverse events

时间窗: Three years

* bleeding risk * adenoma recurrence

次要结局

  • Pain post procedure(Three years)
  • Duration of endoscopic procedure(Three years)
  • Perforation (peri-procedure and delayed)(Three years)
  • Hospital readmission(Three years)
  • Change in Spigelman stage(Three years)

研究者

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

Professor Michael Bourke

Director of Gastrointestinal Endoscopy

Western Sydney Local Health District

研究点 (1)

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