LithiasisSIAGLANCT04886440
Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis
An observational study of Lithiasis, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
Salivary disorders are common reason for ENT specialist consultation. Sialolithiasis are the most frequent salivary obstruction disease and are characterized by the development of calcified structures in the salivary gland, especially in the submandibular gland. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lithiasis
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 25 Mar 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with submandibular sialolithiasis
Who may be able to join
- Adult patient
- Patient treated in CHR Metz-Thionville between 2013 and 2020
- With a pathological impairment (suspected or confirmed) of a salivary gland
- With sialendoscopy indication for diagnosis and/or treatment
Who cannot join
- Opposed to use data
- Without sialendoscopy indication
- Without lithiasis salivary gland disorder
- With parotid gland lithiasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of the Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis: a Retrospective Study
Salivary disorders are common reason for ENT specialist consultation. Sialolithiasis are the most frequent salivary obstruction disease and are characterized by the development of calcified structures in the salivary gland, especially in the submandibular gland.
The management of salivary obstruction has changed over the past 30 years. Sialendoscopy is considered as a minimally invasive procedure that allows endoscopic visualization of the salivary ductal system and is increasingly used in both diagnosis and treatment. Moreover, many studies have shown the effectiveness of this procedure.
Classification of lithiasis has been set up in 2008 to standardize the nomenclature and was used for patient care since 2009. The main objective of this study is to evaluate the relevance of the lithiasis's classification to predict the efficacy of sialendoscopy in treatment of sialolithiases.
- Conditions
- Lithiasis
- Keywords
- sialendoscopy, submandibular gland, classification
- Medical subject headings
- Lithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of symptom
Absence or presence of symptoms associated to lithiasis
Measured: Month 6
Secondary outcomes (3)
Number of clinical signs
number of clinical signs of the clinical suspicion
Measured: Day 1
Number of intraoperative complications
number of intraoperative complications
Measured: Day 1
Number of post-operative complications
Number of post-operative complications
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Jan 2021
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LithiasisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886440
- Sponsor's protocol ID
- 2021-01Obs-CHRMT
- Acronym
- SIAGLA
- Status last verified
- Aug 2022
- First submitted
- 10 May 2021
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of the Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04886440
- Acronym / sponsor ID
- SIAGLA / 2021-01Obs-CHRMT
- Conditions
- Lithiasis
- Keywords
- sialendoscopy, submandibular gland, classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 14 May 2021 (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.
Salivary disorders are common reason for ENT specialist consultation. Sialolithiasis are the most frequent salivary obstruction disease and are characterized by the development of calcified structures in the salivary gland, especially in the submandibular gland.
The management of salivary obstruction has changed over the past 30 years. Sialendoscopy is considered as a minimally invasive procedure that allows endoscopic visualization of the salivary ductal system and is increasingly used in both diagnosis and treatment. Moreover, many studies have shown the effectiveness of this procedure.
Classification of lithiasis has been set up in 2008 to standardize the nomenclature and was used for patient care since 2009. The main objective of this study is to evaluate the relevance of the lithiasis's classification to predict the efficacy of sialendoscopy in treatment of sialolithiases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with submandibular sialolithiasis
Key inclusion criteria (4 listed)
- Adult patient
- Patient treated in CHR Metz-Thionville between 2013 and 2020
- With a pathological impairment (suspected or confirmed) of a salivary gland
- With sialendoscopy indication for diagnosis and/or treatment
Key exclusion criteria (4 listed)
- Opposed to use data
- Without sialendoscopy indication
- Without lithiasis salivary gland disorder
- With parotid gland lithiasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence of symptom
Time frame: Month 6
Absence or presence of symptoms associated to lithiasis
3 secondary outcomes
Number of clinical signs
Time frame: Day 1
Number of intraoperative complications
Time frame: Day 1
Number of post-operative complications
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
Related trials for Lithiasis
Not yet recruiting
Access Sheaths With Aspiration for Renal RetrOgrade Surgery, Randomized CompArative Outcomes
Urolithiasis, Nephrolithiasis
Recruiting
Evaluation of the Safety and Performance of the Hydrustent® Biodegradable Hydrogel Ureteral Stent
Urinary Lithiasis
Recruiting
Maintenance of an Antiaggregation by Acetylsalicylic Acid, While a Extracorporeal Lithotripsy Session on a Kidney Stone is Perfomed: Comparative Unicentric Prospective Study
Renal Lithiasis, Antiplatelet
RecruitingObservational study
Stone Disease of the Urinary Tract in Children
Urinary Lithiasis
RecruitingObservational study
Protocol No. 2016 - Calculosis- Endourology;
Calculosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lithiasis, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 31 Aug 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of symptom (time frame: Month 6). 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 31 Aug 2022.