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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parotitis, Juvenile Recurrent
• Intervention / Treatment: Procedure: Sialoendoscopy

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.)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rita Yuval, RN; Phone Number: +97248250279; Email: ritayuval@gmail.com

Study Locations

• Israel
  • Haifa, Israel, 34362
    • Department of Otolaryngology, Carmel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Watchfull waiting
Active Comparator: Interventional	Procedure: Sialoendoscopy; Sialoendoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of flare-ups	3 years
Quality of Life (QoL ) Questionnaire	3 years

Collaborators and Investigators

• Sponsor: Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Juvenile; Parotitis; Sialoendoscopy; Watchfull waiting
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Parotid Diseases; Sialadenitis; Recurrence; Parotitis
• Other Study ID Numbers: CMC-18-0075-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No