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临床试验/NCT07252180
NCT07252180进行中(未招募)不适用

A Prospective Study Comparing Patient Satisfaction and Efficacy of Two Different Methods of Ablation of Inlet Patches: Argon Plasma Coagulation Versus Radio Frequency Ablation

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
72
试验地点
1
主要终点
Patient satisfaction

研究概览

简要总结

The goal of this prospective study is to compare 2 different treatment options for the ablation of inlet patches in patients with esophageal symptoms. The main questions it aims to answer are:

Is 1 method more effective than the other? Do patients prefer 1 method over the other?

Participants will undergo ablation with either argon plasma or radiofrequency.

详细描述

Inlet patches (IP) are areas of ectopic gastric mucosa in the proximal esophagus. [1-4] They also been referred to as cervical inlet patch (CIP), heterotopic gastric mucosa (HGM), heterotopic gastric mucosa of the proximal esophagus (HGMPE), and heterotopic gastric mucosa of the upper esophagus (HGMUE). While initially thought to be rare, they are in fact frequently found. Recent studies, including those specifically evaluating for their presence, have found IP in 10-14% of patients undergoing endoscopy [5-10].

While frequently identified as an incidental lesion, there is growing data that IP can cause symptoms, many of which are attributed to their ability to produce acid [11-13]. A recent meta-analysis comparing patients with IP to those without IP identified heartburn, dysphagia, throat discomfort, globus, hoarseness, and cough as being more prevalent in patients with IP [14].

Studies have shown that some throat symptoms have improved with ablation of IP performed during upper endoscopy [15-23]. The initial prospective studies involved treatment using argon plasma coagulation (APC) and showed safety, effective ablation of the IP, and improvement in symptoms [15-17]. Similar results have been shown in more recent larger retrospective studies [18,19], as well as in pediatric populations [20,21]. While most studies used APC to ablate IP, some studies also showed that radio frequency ablation (RFA) was successful in eradicating IP and improving symptoms [22,23]. However, to date, no studies have compared these two ablative methods.

In the investigators' experience, they have successfully used both methods to ablate IP. However, several patients have complained of sore throats after APC ablation, and the investigators have not experienced this after RFA. Additionally, in prior studies, patient satisfaction with these procedures has not been explored.

Aims The aims are to compare two proven methods of ablating IP-APC and RFA. The primary endpoint will be to compare patient satisfaction with the procedures (rated on a 0-10 scale), as well as complaints of pain or discomfort afterwards. Secondarily, the investigators will compare the efficacy of ablation between the two methods in terms of the number of sessions required to achieve complete IP eradication. Finally, the investigators will also assess differences in symptom improvement between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Inlet patch >5 mm in size
  • Esophageal or throat symptoms
  • Willing to participate

排除标准

  • No inlet patch
  • Unwilling to participate

结局指标

主要结局

Patient satisfaction

时间窗: 5 days after intervention

The main outcome will be the patient satisfaction score assessed five days after the initial ablation. This score will be on a 0-10 scale where 0 represents a horrible experience and 10 represents a wonderful experience. This score will be compared between the two groups.

Patient satisfaction

时间窗: 5 days after intervention

The main outcome will be the patient satisfaction score assessed five days after the initial ablation. This score will be on a 0-10 scale where 0 represents a horrible experience and 10 represents a wonderful experience. This score will be compared between the two groups.

次要结局

  • Procedures to eradication(1 month after interventions)
  • Improvement in symptoms(1 month after interventions)
  • Procedures to eradication(1 month after interventions)
  • Improvement in symptoms(1 month after interventions)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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