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临床试验/NCT04074694
NCT04074694Unknown不适用

Treatment of Juvenile Recurrent Parotitis: the Yield of Minimally Invasive Intervention, a Prospective Controlled Study

Carmel Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Quality of Life (QoL ) Questionnaire

研究概览

简要总结

Juvenile recurrent parotitis (JRP) is an inflammatory disease characterized by recurrent painful swelling of the Parotid gland in the pediatric age. A watchful waiting treatment strategy was acceptable for most children; however, recent studies claimed that a sialoendoscopic intervention may stop the recurrent flare-ups.

The Objective of our study:

To determine the effectiveness of sialoendoscopy vs. conservative therapy ('watch and wait') alone for Juvenile Recurrent Parotitis

Research Endpoints:

The study's endpoints will evaluate frequency and severity of flare-ups before and after treatment and Quality of Life parameters as evaluated according to life-quality questionnaires.

详细描述

Juvenile recurrent parotitis (JRP) is an inflammatory disease characterized by recurrent painful swelling of the Parotid gland in the pediatric age. A watchful waiting treatment strategy was acceptable for most children; however, recent studies claimed that a sialoendoscopic intervention may stop the recurrent flare-ups.

Moreover, the accessibility to this treatment modality and furthermore to the skillful operators are yet limited in many medical centers.

Juvenile Recurrent Parotitis is defined as a non-obstructive, non-suppurative inflammatory disease characterized by unilateral or bilateral parotid gland swelling recurring at least twice before puberty. It is the second most common salivary gland disease in children after mumps, in young children it is difficult to differentiate between the two. The clinical symptoms of JRP include intermittent and usually unilateral (might also be bilateral, usually with symptoms more prominent on one side) swelling of the parotid gland which occurs in quite a sudden pattern (over a course of houres or even minutes) and may persist for days or weeks, usually associated with local pain and erythema of the overlying skin, and systemic manifestation such as malaise and fever. The first episode typically occurs between ages 3-6, more often in males than females.

The etiology of JRP is still obscure, though a variety of causative factors have been proposed as contributing to JRP, such as dental congenital malformations, congenital duct malformation, genetic factors and immunological anomalies.

In addition to the conservative follow-up treatment modality, management with operative endoscopic treatment is another considerable option, that is now gaining stronger evidence of efficacy.

研究设计

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

入排标准

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

入选标准

  • age 3-18 y/o at least 2 documented incidents in at least 12 months period

排除标准

  • previous parotis interventions e.g. sialography/sialendoscopy/parotidectomy parotitis due to any other known cause (e.g. bacterial infection, autoimmune disease etc.)

研究组 & 干预措施

Watchfull waiting

No Intervention

Interventional

Active Comparator

干预措施: Sialoendoscopy (Procedure)

结局指标

主要结局

Quality of Life (QoL ) Questionnaire

时间窗: 3 years

Frequency of flare-ups

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方
Carmel Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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