Parotitis, Juvenile RecurrentJRPNCT04074694
Treatment of Juvenile Recurrent Parotitis: the Yield of Minimally Invasive Intervention
A study testing Sialoendoscopy in people with Parotitis, Juvenile Recurrent, run by Carmel Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Parotitis, Juvenile Recurrent
- What is being tested?
- Sialoendoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2020to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 3-18 y/o at least 2 documented incidents in at least 12 months period
Who cannot join
- previous parotis interventions e.g. sialography/sialendoscopy/parotidectomy parotitis due to any other known cause (e.g. bacterial infection, autoimmune disease etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.)
- Conditions
- Parotitis, Juvenile Recurrent
- Being tested
- Sialoendoscopy
- Keywords
- Parotitis, Juvenile, Sialoendoscopy, Watchfull waiting
- Medical subject headings
- Parotitis, Juvenile Recurrent, Parotitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SialoendoscopyProcedure or surgery
Sialoendoscopy
| Study group | Role | What they receive |
|---|---|---|
| Watchfull waiting | No intervention | Not described |
| Interventional | Active comparator | Not described Receives: Procedure: Sialoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of flare-ups
Measured: 3 years
Quality of Life (QoL ) Questionnaire
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotitis, Juvenile RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074694
- Sponsor's protocol ID
- CMC-18-0075-CTIL
- Acronym
- JRP
- Status last verified
- Aug 2019
- First submitted
- 29 Aug 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Juvenile Recurrent Parotitis: the Yield of Minimally Invasive Intervention, a Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT04074694
- Acronym / sponsor ID
- JRP / CMC-18-0075-CTIL
- Conditions
- Parotitis, Juvenile Recurrent
- Keywords
- Parotitis, Juvenile, Sialoendoscopy, Watchfull waiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Watchfull waiting | No intervention | – |
| Interventional | Active comparator | Procedure: Sialoendoscopy |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- age 3-18 y/o at least 2 documented incidents in at least 12 months period
Key exclusion criteria (1 listed)
- previous parotis interventions e.g. sialography/sialendoscopy/parotidectomy parotitis due to any other known cause (e.g. bacterial infection, autoimmune disease etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SialoendoscopySialoendoscopy | Procedure or surgery | Interventional |
Primary outcome
Frequency of flare-ups
Time frame: 3 years
Quality of Life (QoL ) Questionnaire
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sialoendoscopy in people with Parotitis, Juvenile Recurrent, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rita Yuval, RN (+97248250279, ritayuval@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of flare-ups (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.