NCT04074694

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

August 29, 2019

Last Update Submit

August 29, 2019

Conditions

Parotitis, Juvenile Recurrent

Keywords

ParotitisJuvenileSialoendoscopyWatchfull waiting

Outcome Measures

Primary Outcomes (2)

  • Frequency of flare-ups

    3 years

  • Quality of Life (QoL ) Questionnaire

    3 years

Study Arms (2)

Watchfull waiting

NO INTERVENTION

Interventional

ACTIVE COMPARATOR
Procedure: Sialoendoscopy

Interventions

SialoendoscopyPROCEDURE

Sialoendoscopy

Interventional

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology, Carmel Medical Center

Haifa, 34362, Israel

Location

MeSH Terms

Conditions

Parotitis, Juvenile RecurrentParotitis

Condition Hierarchy (Ancestors)

Parotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesSialadenitis

Central Study Contacts

Rita Yuval, RN

CONTACT

+97248250279ritayuval@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2019

First Posted

August 30, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)