Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04074694 |
| Other study ID # |
CMC-18-0075-CTIL |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
August 2019 |
| Source |
Carmel Medical Center |
| Contact |
Rita Yuval, RN |
| Phone |
+97248250279 |
| Email |
ritayuval[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
The procedure of sialoendoscopy has an increasing value of diagnosis and treatment of JRP, as
it provides direct visualization of the ductal system and the abilty of treatment via lavage
and irrigation of medical agents, such as steroids. There are a few reports indicating better
outcomes (e.g. fewer exacerbations) using this modality
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.
Inclusion criteria:
- age 3-18 y/o
- at least 2 documented incidents in at least 12 months period
Exclusion criteia:
- previous parotis interventions e.g. sialography/sialendoscopy/parotidectomy
- parotitis due to any other known cause (e.g. bacterial infection, autoimmune disease
etc.)
