跳至主要内容
临床试验/NCT01056003
NCT01056003Unknown不适用

Gastric Inlet Patches of the Cervical Esophagus. Incidental Finding or Underrated Cause of Globus Sensations.

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
4,000
试验地点
1

研究概览

简要总结

As known from several observational and retrospective endoscopic studies the prevalence of gastric inlet patches (GIPs) of the cervical esophagus is estimated between 1-10%. In most cases GIPs are found within endoscopy as an incident finding, since in most cases they are harmless and do not cause any symptoms. None the less several data exist where an association between GIPs and globus sensations is discussed. Case reports even refer to bleeding complications and moreover to malignant transformations of GIPs.

As a result of the assumed association of GIPs and globus sensations we performed a pilot trial. Here we included 10 patients with globus and GIPs and were able to demonstrate a significant symptom relief after ablation of the GIP (Meining et al, Endoscopy 2006). To exclude a potential placebo-effect we concluded a multicenter and sham controlled trial where we imposingly were able to prove the symptom relief after ablation of the GIPs (Bajbouj et al, Gastroenterology 2009).

All patients, who are scheduled for esophagogastroduodenoscopy (EGD) in any of the above mentioned endoscopical departments are routinely standardized asked whether they have any hints suggestive for globus sensations (modified globus-questionnaire from Deary et al., J Psychosom Res 1995). Concurrently it is noted, whether the patients have endoscopical detected GIP. All GIPs are biopsied and examined in one institute. Together with anamnestic data (age, gender) a talley sheet gives a survey of all relevant information to prove or disprove following hypotheses.

Study hypotheses:

  1. The presence of GIPs is associated with globus sensations. In other words: Do patients with globus sensations significantly more often have GIPs?
  2. GIPs are not congenital, they arise in the course of the time and become symptomatic. In other words: Do GIPs significantly occur in more elderly people?
  3. The more increased the GIPs diameter is the more likely globus sensations are present? In other words: Do huge GIPs cause significantly more often symptoms than small ones?
  4. The more mucus-producing mucosa is histologically proven the more likely globus sensations are present? In other words: Do we find more cardiac mucosa in patients with symptoms than fundus mucosa?

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
— 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • emergency EGD
  • any condition which contraindicates biopsy sampling
  • unavailable informed consent for the GD

研究者

发起方
Technical University of Munich
申办方类型
Other

研究点 (1)

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