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临床试验/NCT02587923
NCT02587923Unknown不适用

A Retrospective Study on Safety, Diagnostic Yield and Therapeutic Effects of Endoscopic Unroofing for Small Gastric Subepithelial Tumors

Medical University of Vienna0 个研究点目标入组 20 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Diagnostic yield

研究概览

简要总结

Background: Accurate diagnosis of small gastric subepithelial tumors (SETs) is essential in order to assess their malignant potential. Endoscopic unroofing by conventional snare or needle knife has been reported to yield sufficient tissue samples for histological evaluation including immunohistochemical staining.

Aims: The investigators aim to evaluate endoscopic unroofing in patients with small gastric SETs regarding its safety and diagnostic accuracy as well as a potential therapeutic effect of this technique over time.

Methods: In the context of a retrospective analysis, the investigators will identify patients who underwent endoscopic unroofing of small SETs of the stomach at the Medical University of Vienna. Demographic data, indication for intervention, safety of the procedure and follow-up will be assessed.

详细描述

INTRODUCTION

Small gastric subepithelial tumors (SETs) are often incidental findings at upper endoscopy. Differential diagnoses include a variety of different pathologies such as gastrointestinal stromal tumors (GISTs), leiomyomas, leiomyosarcomas, lipomas, carcinoid tumors, granular cell tumors, duplication cysts or pancreatic rests. Since some of these entities have a potential of malignancy, accurate classification of gastric SETs is essential to define the best diagnostic and therapeutic management. Endosonography (EUS) is the current gold standard for further characterization of small gastric SETs. It provides differentiation between extra- and intramural lesions, information on the involvement of certain wall layers, measurement of a lesion as well as structural analysis according to the echogenicity of a lesion. Nevertheless, a level of uncertainty remains, even if a lesion shows a typical echo-pattern and layer involvement.

According to current guidelines, lesions of more than two centimeters in size that are suspected to be GISTs should be removed by surgical resection. Lesions less than one centimeter can be followed by annual EUS. For lesions bigger than one centimeter but smaller than two centimeters tissue sampling is recommended in order to correctly diagnose a lesion according to immunohistochemical markers (such as CD117 or CD34 in GISTs) and to quantify the malignant potential according to other histological factors (such as the mitotic index in GISTs) [1].

Tissue sampling can be done by using standard or jumbo forceps biopsy and EUS-guided fine needle aspiration or biopsy, but the diagnostic yield of these methods is rather low [2,3]. Better results can be achieved by endoscopic resection techniques such as endoscopic submucosal dissection (ESD), submucosal tunneling endoscopic resection or full thickness endoscopic resection [4,5]. The main advantage of these approaches is that they are not only diagnostic but also therapeutic strategies since the respective lesion can be resected as a whole comparable with conventional surgery. However, there is a high risk of procedure related adverse events such as bleeding or perforation (the latter is often unavoidable considering that most SETs are arising from deep wall layers such as the muscularis propria layer).

Endoscopic unroofing is very similar to the mentioned endoscopic resection techniques with the main difference that only partial resection is intended in order to get a representative tissue specimen for histological evaluation. This method has been described in a case series by Lee et al. in 2010 where it showed a very favorable diagnostic yield in gastric SETs [6]. To date, no study has reported on the follow-up of lesions investigated by endoscopic unroofing.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Diagnostic yield

时间窗: 1 week

Proportion of study patients with a histologically confirmed diagnosis after endoscopic unroofing.

Adverse Events

时间窗: 30 days

Peri-interventional adverse events whether related or not

Tumor status after endoscopic unroofing

时间窗: 12 months

Local result during follow up after endoscopic unroofing (proportion of patients with no change vs. partial remission vs. complete remission)

次要结局

未报告次要终点

研究者

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

Werner Dolak, MD

Assistant Doctor

Medical University of Vienna

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Endoscopic Unroofing for Small Gastric SETs | 临床试验