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Treatment of Juvenile Recurrent Parotitis: the Yield of Minimally Invasive Intervention (JRP)

Primary Purpose

Parotitis, Juvenile Recurrent

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Sialoendoscopy
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parotitis, Juvenile Recurrent focused on measuring Parotitis, Juvenile, Sialoendoscopy, Watchfull waiting

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department of Otolaryngology, Carmel Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Watchfull waiting

Interventional

Arm Description

Outcomes

Primary Outcome Measures

Frequency of flare-ups
Quality of Life (QoL ) Questionnaire

Secondary Outcome Measures

Full Information

First Posted
August 29, 2019
Last Updated
August 29, 2019
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04074694
Brief Title
Treatment of Juvenile Recurrent Parotitis: the Yield of Minimally Invasive Intervention
Acronym
JRP
Official Title
Treatment of Juvenile Recurrent Parotitis: the Yield of Minimally Invasive Intervention, a Prospective Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carmel Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parotitis, Juvenile Recurrent
Keywords
Parotitis, Juvenile, Sialoendoscopy, Watchfull waiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Watchfull waiting
Arm Type
No Intervention
Arm Title
Interventional
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Sialoendoscopy
Intervention Description
Sialoendoscopy
Primary Outcome Measure Information:
Title
Frequency of flare-ups
Time Frame
3 years
Title
Quality of Life (QoL ) Questionnaire
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 3-18 y/o at least 2 documented incidents in at least 12 months period Exclusion Criteria: previous parotis interventions e.g. sialography/sialendoscopy/parotidectomy parotitis due to any other known cause (e.g. bacterial infection, autoimmune disease etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rita Yuval, RN
Phone
+97248250279
Email
ritayuval@gmail.com
Facility Information:
Facility Name
Department of Otolaryngology, Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Juvenile Recurrent Parotitis: the Yield of Minimally Invasive Intervention

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