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临床试验/NCT03185390
NCT03185390已完成不适用

Periampullary Lesions Via ERCP in Assuit University Hospital

Assiut University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
percentage of different types of periampullary massesand efficacy of ERCP guided biopsy calculating the number of cases correctly diagnosed by ERCP or guided biopsy

研究概览

简要总结

A periampullary lesion may be begin as duodenal adenoma, ampullary adenoma, gall stone pregnant ampulla, Stricture, or periampullary lipoma, or malignant as pancreatic ductal adenocarcinoma, distal CBD cholangiocarcinoma, ampullary carcinoma and periampullary duodenal adenocarcinoma, pancreatic carcinoma.

The aim of the study is to detect incidence of different types of periampullary lesions detected by ERCP in Assuit University Hospital and the role of ERCP in early detection, diagnosis and management and diagnostic accuracy and sensitivity of biopsy and brush cytology taken by ERCP in a period of 1 years starting from June 2017 to June 2018.

详细描述

Periampullary lesion is defined as lesion located in 2CM around the ampulla of Vater. Periampullary lesions, identified during endoscopic retrograde cholangiopancreatography (ERCP), duodenoscopy or endoscopic ultrasonography (EUS) often present a diagnostic dilemma. Although some of these lesions represent a benign lesion, they also occur in case of malignancy. Therefore, management of periampullary lesions widely varies from observation for low-grade dysplasia to pancreaticoduodenectomy in case of invasive carcinoma. Unfortunately, endoscopic biopsies are by definition superficial and, therefore, the risk of a sample errors exists. On the other hand the similarity in presentation and the difficulty in accurate location of the origin of these lesions often leads to a diagnostic challenge. ERCP in addition to its diagnostic value it allows therapeutic procedures, such as sphincterotomy, stenting, and nasobiliary drainage. It permits sampling of pancreatic juice, bile, and brush or grasp biopsy, but endoscopic biopsies are by definition superficial and, therefore, the risk of a sample errors exists .

ERCP is an invasive procedure that requires an expert endoscopist/radiologist and a cooperative patient.

Very small tumors (< 1 cm) can be missed. A periampullary lesion may be begin as duodenal adenoma, ampullary adenoma, gall stone pregnant ampulla, Stricture, or periampullary lipoma, or malignant as pancreatic ductal adenocarcinoma, distal CBD cholangiocarcinoma, ampullary carcinoma and periampullary duodenal adenocarcinoma, pancreatic carcinoma.

The aim of the study is to detect incidence of different types of periampullary lesions detected by ERCP in Assuit University Hospital and the role of ERCP in early detection, diagnosis and management and diagnostic accuracy and sensitivity of biopsy and brush cytology taken by ERCP in a period of 1 years starting from June 2017 to June 2018.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All cases admitted in Assuit university hospital with periampullary lesions detected by ERCP within the period of the study.

排除标准

  • Cases diagnosed to have periampullary lesion and managed without ERCP

结局指标

主要结局

percentage of different types of periampullary massesand efficacy of ERCP guided biopsy calculating the number of cases correctly diagnosed by ERCP or guided biopsy

时间窗: one year

次要结局

  • number of cases addmited in Assiut University Hospital with differrent types of periampullary mass diagnosed correctly by the help of ERCP(one year)

研究者

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

emad mamdouh

Principle invvestigat

Assiut University

研究点 (1)

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